Genotropin

Package leaflet: Information for the user

Genotropin MiniQuick 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg,
2.0 mg, powder and solvent for injectable solution
somatropin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Genotropin MiniQuick is and what it is used for
2. What you need to know before taking Genotropin MiniQuick
3. How to take Genotropin MiniQuick
4. Possible side effects
5. How to store Genotropin MiniQuick
6. Contents of the pack and other information

1. WHAT GENOTROPIN MINIQUICK IS AND WHAT IT IS USED FOR

Genotropin MiniQuick is a medicine containing recombinant human growth hormone (also known as somatropin). It has the same structure as the growth hormone naturally produced by the human body, which is necessary for the growth of bones and muscles. Growth hormone also helps fat and muscle tissues to develop properly. It is termed "recombinant" because it does not originate from human or animal tissue.

In children, Genotropin MiniQuick is used to treat the following growth disorders:

• If the child is not growing properly due to insufficient levels of growth hormone.
• If the child has Turner syndrome. Turner syndrome is a chromosomal abnormality affecting girls and may negatively affect growth – your doctor will have informed you if your child has this condition.
• If the child has chronic renal insufficiency. In this case, the kidneys lose their normal function, which may impair growth.
• If the child has Prader-Willi syndrome (a disease caused by a chromosomal abnormality). Growth hormone will help the child grow taller if still in a growth phase, and will improve body composition. Excess fat will decrease and reduced muscle mass will improve.
• If the child was born small or with low birth weight. Growth hormone may help the child grow taller if normal growth has not been achieved or maintained by the age of 4 years or beyond.

In adults, Genotropin MiniQuick is used to treat individuals with severe growth hormone deficiency. This deficiency may develop during adulthood or may have originated in childhood.
If you were treated with Genotropin MiniQuick during childhood due to growth hormone deficiency, your growth hormone status must be re-evaluated upon completion of growth. If a severe growth hormone deficiency is confirmed, your doctor may recommend continuing treatment with Genotropin MiniQuick.

This medicine must be prescribed only by a physician experienced in growth hormone therapy, who has confirmed your diagnosis.

2. WHAT YOU SHOULD KNOW BEFORE TAKING GENOTROPIN MINIQUICK

Do not use Genotropin MiniQuick and inform your doctor
If you are allergic (hypersensitive) to somatropin or to any of the other ingredients in Genotropin MiniQuick.
If you have an active tumor (cancer). Tumors must be inactive and anti-tumor therapy must
be completed before starting treatment with Genotropin MiniQuick.
If you are severely ill (for example, due to complications following open-heart surgery, abdominal surgery, acute respiratory failure, accidental trauma, or similar conditions). If you are undergoing or have recently undergone major surgery, or if you are admitted to hospital for any reason, inform your doctor and remind other physicians managing your care that you are receiving growth hormone therapy.
If Genotropin MiniQuick has been prescribed to stimulate growth, but growth has already stopped (epiphyses have fused).

Use particular caution with Genotropin MiniQuick and inform your doctor if any of the following
conditions apply to you

• If you are at risk of developing diabetes, your doctor should monitor your blood glucose levels during treatment with Genotropin MiniQuick. If you have diabetes, you must carefully monitor your blood glucose levels during treatment with Genotropin MiniQuick and discuss the results with your doctor to determine whether adjustment of your diabetes medication dosage is needed. After starting treatment with Genotropin, some patients may need to begin replacement therapy with thyroid hormones. If you are already taking thyroid hormones, your dosage may need to be adjusted. If you are taking growth hormone to stimulate growth and you have a limp or develop a limp during treatment with growth hormone due to hip pain, you must inform your doctor. If you experience increased intracranial pressure (with symptoms such as severe headache, visual disturbances, or vomiting), inform your doctor. If Genotropin MiniQuick has been prescribed due to growth hormone deficiency following a previous tumor (cancer), you must be regularly monitored for tumor recurrence or development of any other cancer. If you notice worsening of abdominal pain, you must inform your doctor. Experience in patients over 80 years of age is limited. Elderly patients may be more sensitive to the effects of Genotropin MiniQuick and therefore more susceptible to adverse effects.

Children with chronic renal insufficiency:
Your doctor must evaluate your kidney function and growth velocity before starting treatment with Genotropin MiniQuick. Medical treatment for your kidney condition must continue. Treatment with Genotropin MiniQuick must be discontinued following kidney transplantation.

Children with Prader-Willi syndrome:
Your doctor will prescribe a diet to help control weight.
Before starting treatment with Genotropin MiniQuick, your doctor will assess for signs of upper airway obstruction, sleep apnea (interruption of breathing during sleep), or respiratory infections.
If during treatment you develop signs of upper airway obstruction (including new onset or worsening of snoring), your doctor must examine you and may discontinue treatment with Genotropin MiniQuick.
During treatment, your doctor will monitor for signs of scoliosis, a type of spinal deformity.
If a lung infection develops during treatment, inform your doctor so that appropriate treatment can be initiated.

Children born small or with low birth weight:
If you were very small at birth or had low birth weight and are between 9 and 12 years old, ask your doctor for specific advice regarding puberty and treatment with this medicine.
Your doctor will check your blood glucose and insulin levels before starting treatment and annually during treatment.
Treatment should continue until growth stops.

Taking other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Warnings and precautions
Talk to your doctor or pharmacist before using Genotropin.
If you are receiving glucocorticoid replacement therapy, you must consult your doctor regularly, as your glucocorticoid dose may need adjustment.
You must inform your doctor if you are taking:

• Medicines for the treatment of diabetes,
• Thyroid hormones,
• Synthetic adrenal hormones (corticosteroids),
• Oral estrogens or other sex hormone therapies,
• Cyclosporine (a medicine that suppresses the immune system after transplantation),
• Medicines used to control epilepsy (anticonvulsants).
  Your doctor may assess whether dosage adjustments of these medicines or of Genotropin MiniQuick are necessary.
  For athletes: The use of this medicine without a therapeutic indication constitutes doping and may lead to a positive anti-doping test.

Pregnancy and breastfeeding
Do not use Genotropin if you are pregnant, think you might be pregnant, or are planning a pregnancy.
Ask your doctor for advice before using this medicine during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Genotropin MiniQuick contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. HOW TO TAKE GENOTROPIN MINIQUICK

Recommended dosage
The dosage depends on your body size, the condition for which you are being treated, and how effectively growth hormone works for you. Every person is different. Your doctor will advise you on the appropriate dose of Genotropin MiniQuick in milligrams (mg), based on your body weight in kilograms (kg) or your body surface area calculated in square meters (m²) according to height and weight, as well as the appropriate administration schedule for you. Do not change the dosage or administration schedule without consulting your doctor.

Children with growth hormone deficiency:
Dose of 0.025–0.035 mg per kg of body weight per day or 0.7–1.0 mg per m² of body surface area per day. Higher doses may also be administered. When growth hormone deficiency persists into adolescence, Genotropin MiniQuick should be used until full physical development is achieved.

Children with Turner syndrome:
Dose of 0.045–0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day.

Children with chronic renal insufficiency:
Dose of 0.045–0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day. Higher doses may be required if growth velocity is too low. Dose adjustment may be necessary after 6 months of treatment.

Children with Prader-Willi syndrome:
Dose of 0.035 mg per kg of body weight per day or 1.0 mg per m² of body surface area per day. The daily dose must not exceed 2.7 mg. Treatment should not be initiated in children whose growth has nearly stopped after puberty.

Children born small for gestational age or with low birth weight and suffering from growth disorders:
Dose of 0.035 mg per kg of body weight per day or 1.0 mg per m² of body surface area per day. It is important to continue treatment until final height is reached. You must stop treatment after the first year if there is no response to therapy or if final height is reached and growth has ceased.

Adults with growth hormone deficiency:
If continuing Genotropin MiniQuick therapy after childhood treatment, start with a dose of 0.2–0.5 mg per day. This dosage should be gradually increased or decreased based on blood test results, clinical response, and side effects.

If growth hormone deficiency develops in adulthood, start treatment with 0.15–0.3 mg per day. This dosage should be gradually increased based on blood test results, clinical response, and side effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be reviewed every 6 months. Patients over 60 years of age should start with a dose of 0.1–0.2 mg per day, which should be gradually increased according to individual needs. Use the lowest effective dose. The daily maintenance dose rarely exceeds 0.5 mg per day. Follow the instructions given by your doctor.

Injection of Genotropin MiniQuick
Genotropin MiniQuick must be administered subcutaneously, i.e., injected into the fatty tissue just beneath the skin, using a short injection needle. Your doctor should have already shown you how to use Genotropin MiniQuick. Always inject Genotropin MiniQuick exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Read the “Instructions for Use” at the end of this Package Leaflet for guidance on how to use Genotropin MiniQuick. If you do not remember what to do, do not attempt the injection. Ask your doctor to demonstrate again how to use Genotropin MiniQuick.

You may remove the medicine from the refrigerator half an hour before injection. This allows the product to warm slightly, making the injection easier.

Remember to wash your hands and clean the skin before injection.

Administer the growth hormone injection every day at approximately the same time. It is recommended to administer the injection before going to bed, as this is easier to remember. Also, it is normal to have higher levels of growth hormone during the night.

Most people inject into the thigh or buttock. Inject at the site shown by your doctor. Repeated injections at the same site may cause reduction of subcutaneous fatty tissue. To avoid this, always inject at a different site each time. This allows the skin and underlying tissue to recover from the previous injection before another injection is given at the same site.

If you use more Genotropin MiniQuick than you should
If you have injected too much Genotropin MiniQuick, contact your doctor or pharmacist immediately. Blood sugar levels may drop too low and subsequently rise too high. You may experience tremors, sweating, drowsiness, feel "not yourself," or may faint.

If you forget to use Genotropin MiniQuick
Do not take a double dose to make up for a missed dose.
It is best to take the growth hormone regularly.

If you forget to take a dose, administer the next injection the following day at the usual time. Record each missed injection and inform your doctor at your next check-up.

If you stop using Genotropin MiniQuick
Consult your doctor before stopping treatment with Genotropin MiniQuick.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Genotropin MiniQuick can cause adverse reactions, although not everyone experiences them. Very common and common adverse reactions in adults may occur within the first few months of treatment and may resolve spontaneously or if the dose is reduced.

Very common adverse reactions (may occur in more than 1 in 10 patients) include:
In adults:

• Joint pain.
• Fluid retention (manifesting as swollen fingers or ankles).

Common adverse reactions (may occur in less than 1 in 10 patients) include:
In children:

• Joint pain.
• Temporary redness, itching, or pain at the injection site.

In adults:

• Numbness, tingling.
• Pain or burning sensation in the hands or armpits (known as Carpal Tunnel Syndrome).
• Aching in arms and legs, muscle pain.

Uncommon adverse reactions (may occur in less than 1 in 100 patients) include:
In children:

• Leukaemia (reported in a limited number of patients with growth hormone deficiency, some of whom had previously been treated with somatropin. However, there is no evidence that the incidence of leukaemia is higher in patients receiving growth hormone in the absence of predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting).
• Numbness, tingling.
• Rash.
• Itching.
• Itchy skin eruptions.
• Muscle pain.
• Breast enlargement (gynaecomastia).
• Fluid retention (manifesting as swollen fingers or ankles, for a short period at the beginning of treatment).

In adults:

• Breast enlargement (gynaecomastia).

Not known: frequency cannot be estimated from available data:

• Type 2 diabetes.
• Facial swelling.
• Headache.
• Decreased blood levels of cortisol hormone.

In children:

• Aching in arms and legs.

In adults:

• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting).
• Rash.
• Itching.
• Itchy skin eruptions.
• Redness, itching, or pain at the injection site.

Formation of antibodies against the injected growth hormone, which however do not appear to block the action of the growth hormone.
The skin around the injection site may become irregular or lumpy, but this can be avoided by always injecting in a different site each time.
Rare cases of sudden death have been reported in patients with Prader-Willi Syndrome. However, these cases have not been associated with treatment with Genotropin MiniQuick.
If, during treatment with Genotropin, you experience hip or knee problems or pain, your doctor may consider the possibility of slipped capital femoral epiphysis or Legg-Calvé-Perthes disease.
Other possible adverse reactions related to treatment with growth hormone may include the following. You (or your child) may develop elevated blood glucose levels (sugar in the blood) or reduced thyroid hormone levels. These can be monitored by your doctor, who may prescribe appropriate treatment if necessary. Rarely, patients treated with growth hormone have reported inflammation of the pancreas.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report adverse reactions directly via the national reporting system (reazioni-avverse).
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GENOTROPIN MINIQUICK

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging in the format Month/Year.
The expiry date refers to the last day of that month.

Before reconstitution:
Store in the refrigerator (+2°C to +8°C). Do not freeze. Keep the syringe in the outer packaging to protect the medicine from light.
Before opening, the product may be stored outside the refrigerator, without returning it to the refrigerator, for a maximum period of 6 months at a temperature not exceeding 25°C. The date on which the medicine is removed from the refrigerator and the new expiry date must be written on the outer packaging. This new expiry date must never exceed the original expiry date stated on the outer packaging. If the medicine is not used before the new expiry date, it must be disposed of.

After reconstitution:
Use immediately or store in the refrigerator (2°C–8°C) for up to a maximum of 24 hours. Do not freeze. Keep the syringe in the outer packaging to protect the medicine from light.
Do not use the medicine if particles are present in the solution or if it is not clear.

Never dispose of needles or empty syringes in household waste. After using a needle, dispose of it carefully in a special container for "sharps" so that no one can reuse it or get injured by it.
Do not dispose of any medicines down the drain or in household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Genotropin MiniQuick contains
The active substance is somatropin*.
After reconstitution, a cartridge contains: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg,
1.4 mg, 1.6 mg, 1.8 mg, or 2.0 mg per 0.25 ml of somatropin*, corresponding to a concentration of
0.8 mg, 1.6 mg, 2.4 mg, 3.2 mg, 4 mg, 4.8 mg, 5.6 mg, 6.4 mg, 7.2 mg, and 8 mg per ml.
The other components of the powder are: glycine (E640), mannitol (E421), sodium dihydrogen
phosphate anhydrous (E339), and disodium phosphate anhydrous (E339).
The components of the solvent are: water for injections and mannitol (E421).
* Produced by Escherichia coli cells using recombinant DNA technology.

Description of the appearance of Genotropin MiniQuick and contents of the pack
Powder and solvent for solution for injection, in a dual-chamber cartridge containing the powder in
one compartment and the solvent in the other (0.2 mg/0.25 ml, 0.4 mg/0.25 ml, 0.6 mg/0.25 ml,
0.8 mg/0.25 ml, 1.0 mg/0.25 ml, 1.2 mg/0.25 ml, 1.4 mg/0.25 ml, 1.6 mg/0.25 ml, 1.8 mg/0.25 ml or
2.0 mg/0.25 ml). The cartridge is contained in a syringe. Packs contain 4, 7, or 28 syringes.
Not all strengths and pack sizes may be marketed.
The powder is white and the solvent is clear and transparent.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo 71
04100 Latina
Italy

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Genotropin MiniQuick: Austria, Denmark, Germany, Greece, Ireland, Italy, Portugal, Sweden, United Kingdom
Genotonorm MiniQuick: Belgium, France, Luxembourg, Spain

This leaflet was last reviewed on.

Genotropin MiniQuick instructions for use
Genotropin MiniQuick is a syringe designed to mix and administer a single dose of Genotropin (growth hormone).
Each Genotropin MiniQuick pack is pre-filled with a dual-chamber cartridge and a needle. If you need additional needles, ask for the same type of needles (Becton Dickinson Micro-Fine) supplied with Genotropin MiniQuick. The injection volume is always 0.25 ml.
Genotropin MiniQuick is for single use only; therefore, after administration of the dose, the device must be discarded as described in section 6.
The figure below identifies the different components.

The dual-chamber cartridge of Genotropin MiniQuick contains the growth hormone powder in one compartment and the solvent in the other. By turning the threaded plunger clockwise, the growth hormone powder and solvent are automatically mixed, and the powder dissolves.

1 Remove the paper protective cap from the needle. Place the needle perpendicularly onto the rubber stopper. Screw the needle onto the Genotropin MiniQuick by turning it clockwise until it stops.

2 Hold the Genotropin MiniQuick with the needle pointing upward and screw the plunger clockwise until it stops.
DO NOT shake the solution. Mix gently. Shaking the solution may cause foaming and damage the active substance. Check that the solution is clear. Use the solution only if it is clear and free from particles.

3 Remove both the outer and inner protective caps from the needle.

4 Grasp a firm fold of skin at the injection site and insert the needle through the skin.

5 Push the plunger completely down to inject the entire content of Genotropin MiniQuick. Wait a few seconds before removing the needle to ensure that all the growth hormone has been injected.

6 After injection, do not attempt to re-sheath the needle. Dispose of the syringe with the needle attached, along with the outer and inner protective caps, according to local regulations or as instructed by your doctor or pharmacist.

QUESTIONS AND ANSWERS

| Question | Answer | |------------|----------| | Is it a problem if I see air bubbles in the syringe? | No. It is not necessary to remove air from the Genotropin MiniQuick syringe. The small amount of air present in the syringe does not affect subcutaneous administration. | | What should I do if I feel resistance when screwing the plunger (step 2) or during injection (step 5)? | Resistance may be due to incorrect angulation when inserting the needle into the rubber stopper. Carefully replace the outer protective cap (the opaque white one) onto the needle and unscrew it counterclockwise to remove the needle. Hold the MiniQuick syringe with the needle end pointing upward and reposition the needle perpendicularly onto the top of the syringe. Screw the needle onto the syringe. | | What should I do if the needle is damaged or bent? | Discard that needle and use a new one with the MiniQuick. |

Package leaflet: information for the user

Genotropin 5.3 mg and 12 mg powder and solvent for injectable solution

somatropin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Genotropin is and what it is used for
2. What you need to know before taking Genotropin
3. How to take Genotropin
4. Possible side effects
5. How to store Genotropin
6. Contents of the pack and other information

2. WHAT GENOTROPIN IS AND WHAT IT IS USED FOR

Genotropin is a medicine containing recombinant human growth hormone (also known as somatropin). It has the same structure as the growth hormone naturally produced by the human body, which is necessary for the growth of bones and muscles. Growth hormone also helps fat and muscle tissue to develop properly. It is called recombinant because it is not derived from human or animal tissue.

In children, Genotropin is used to treat the following growth disorders:

• If the child is not growing properly and does not produce sufficient amounts of growth hormone.
• If the child has Turner Syndrome. Turner Syndrome is a chromosomal abnormality affecting girls and may negatively affect growth – your doctor should have informed you if your child has this condition.
• If the child has chronic renal insufficiency. In this case, the kidneys lose their normal function, which may impair growth.
• If the child has Prader-Willi Syndrome (a disorder caused by a chromosomal abnormality).
  Growth hormone will help the child grow taller if still in the growing phase, and will improve body composition. Excess fat will decrease and the reduced muscle mass will improve.
• If the child was born too small or with low birth weight. Growth hormone may help the child grow taller if normal growth has not been achieved or maintained by the age of 4 years or beyond.

In adults, Genotropin is used to treat individuals with severe growth hormone deficiency. This deficiency may develop during adulthood or may have originated in childhood.

If you were treated with Genotropin during childhood due to growth hormone deficiency, your growth hormone status should be re-evaluated upon completion of growth. If a severe growth hormone deficiency is confirmed, your doctor may recommend continuing treatment with Genotropin.

This medicine must be prescribed only by a physician experienced in growth hormone therapy, who has confirmed the diagnosis.

4. WHAT YOU SHOULD KNOW BEFORE TAKING GENOTROPIN

Do not use Genotropin and inform your doctor
if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of
Genotropin.
if you have an active tumor (cancer). Tumors must be inactive and anti-tumor therapy must
be completed before starting treatment with Genotropin.
if you are severely ill (for example, due to complications following open-heart surgery, abdominal surgery, acute respiratory failure, accidental trauma, or similar conditions). If you are undergoing, or have recently undergone, major surgery, or if you are admitted to hospital for any reason, inform your doctor and remind other physicians managing your care that you are receiving growth hormone therapy.
if Genotropin has been prescribed to stimulate growth, but growth has already stopped (epiphyses have fused).

Use particular caution with Genotropin and inform your doctor if any of the following conditions apply to you

• If you are at risk of developing diabetes, your doctor should monitor your blood glucose levels during treatment with Genotropin. If you have diabetes, you must carefully monitor your blood glucose levels during treatment with Genotropin and discuss the results with your doctor to assess whether adjustment of your diabetes medication dosage is needed. After starting treatment with Genotropin, some patients may need to start replacement therapy with thyroid hormones. If you are already taking thyroid hormones, their dosage may need to be adjusted. If you are taking growth hormone to stimulate growth and you develop a limp, or if you start limping during growth hormone treatment due to hip pain, you must inform your doctor. If you experience increased intracranial pressure (with symptoms such as severe headache, visual disturbances, or vomiting), inform your doctor. If your doctor detects inflammation of the muscles near the injection site caused by the preservative metacresol, you should use Genotropin without metacresol. If Genotropin has been prescribed due to growth hormone deficiency following a previous tumor (cancer), you must be regularly monitored for tumor recurrence or development of any other cancer. If you notice worsening of abdominal pain, you must inform your doctor. Experience in patients over 80 years of age is limited. Elderly patients may be more sensitive to the effects of Genotropin and therefore more susceptible to adverse effects.

Children with chronic renal insufficiency:
Your doctor must evaluate your kidney function and growth rate before starting treatment with Genotropin. Medical treatment for your kidney condition must continue. Treatment with Genotropin must be discontinued after kidney transplantation.

Children with Prader-Willi syndrome:
Your doctor will prescribe a diet to control body weight.
Before starting treatment with Genotropin, your doctor will assess for signs of upper airway obstruction, sleep apnea (interruption of breathing during sleep), or respiratory infections.
If during treatment you develop signs of upper airway obstruction (including new onset or worsening of snoring), your doctor must evaluate you and may discontinue treatment with Genotropin.
During treatment, your doctor will monitor for signs of scoliosis, a type of spinal deformity.
If you develop a lung infection during treatment, inform your doctor so that appropriate treatment can be provided.

Children born small or with low birth weight:
If you were very small or had low birth weight at birth and are between 9 and 12 years old, ask your doctor for specific advice regarding puberty and treatment with this medicine.
Your doctor will check your blood glucose and insulin levels before starting treatment and annually during treatment.
Treatment should continue until growth stops.

Taking other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Warnings and precautions
Talk to your doctor or pharmacist before using Genotropin.
If you are receiving glucocorticoid replacement therapy, you must consult your doctor regularly, as your glucocorticoid dose may need adjustment.
You must inform your doctor if you are taking:
medicines for the treatment of diabetes,
thyroid hormones,
synthetic adrenal hormones (corticosteroids),
oral estrogens or other sex hormone therapies,
cyclosporine (a medicine that suppresses the immune system after transplantation),
medicines used to control epilepsy (anticonvulsants).
Your doctor may consider whether the dosage of these medicines or the dosage of Genotropin needs to be adjusted.
For individuals engaged in sports: using this medicine without a therapeutic indication constitutes doping and may lead to a positive anti-doping test.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are planning a pregnancy, you must not use Genotropin.
Ask your doctor for advice before using this medicine during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Genotropin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., essentially “sodium-free”.

5. HOW TO USE GENOTROPIN

Recommended dosage
The dosage depends on your body size, the condition being treated, and how effectively the growth hormone works for you. Each person is different. Your doctor will advise you on the appropriate dose of Genotropin in milligrams (mg), based on your body weight in kilograms (kg) or your body surface area calculated in square meters (m²) from your height and weight, as well as the appropriate administration schedule for you. Do not change either the dosage or the administration schedule without consulting your doctor.

Children with growth hormone deficiency:
Dose of 0.025–0.035 mg per kg of body weight per day or 0.7–1.0 mg per m² of body surface area per day. Higher doses may also be administered. When growth hormone deficiency continues into adolescence, Genotropin should be used until full physical development is achieved.

Children with Turner syndrome:
Dose of 0.045–0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day.

Children with chronic renal insufficiency:
Dose of 0.045–0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day. Higher doses may be required if growth velocity is too low. Dose adjustment may be necessary after 6 months of treatment.

Children with Prader-Willi syndrome:
Dose of 0.035 mg per kg of body weight per day or 1.0 mg per m² of body surface area per day. The daily dose of 2.7 mg must not be exceeded. Treatment should not be used in children whose growth has nearly stopped after puberty.

Children born small or with low birth weight and affected by growth disorders:
Dose of 0.035 mg per kg of body weight per day or 1 mg per m² of body surface area per day. It is important to continue treatment until final height is reached. You must discontinue treatment after the first year if there is no response to therapy or if final height is achieved and growth stops.

Adults with growth hormone deficiency:
If continuing Genotropin therapy after childhood treatment, start with a dose of 0.2–0.5 mg per day. This dosage should be gradually increased or decreased based on blood test results, clinical response, and side effects.
If growth hormone deficiency develops in adulthood, start treatment with 0.15–0.3 mg per day. This dosage should be gradually increased based on blood test results, clinical response, and side effects. The maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be reviewed every 6 months. Individuals over 60 years of age should start with a dose of 0.1–0.2 mg per day, which should be gradually increased according to individual needs. The lowest effective dose should be used. The daily maintenance dose rarely exceeds 0.5 mg per day. Follow the instructions provided by your doctor.

Injection of Genotropin:
Genotropin must be administered subcutaneously, i.e., injected into the fatty tissue just beneath the skin, using a short injection needle. Your doctor should have already shown you how to use Genotropin. Always inject Genotropin exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The instructions for use of the pre-filled pen GoQuick are provided in the package together with the pre-filled pen.
The instructions for use of Genotropin dual-chamber cartridges with Genotropin Pen are provided with the devices.
Please consult the instructions for use before using this medicine.

When using the pre-filled pen, injection pen, or reconstitution device, the needle must be screwed on before reconstitution. Use a new needle for each injection. Do not reuse needles.

• Preparation of the injection
  You may take Genotropin out of the refrigerator half an hour before injection. This allows the product to warm slightly, making the injection easier.

The pre-filled pen GoQuick contains a dual-chamber cartridge that holds both the growth hormone and the solvent. The growth hormone and solvent are mixed by gently inverting the cartridge holder (see specific steps in the Instructions for Use). No separate device is required.
Genotropin in dual-chamber cartridges contains both the growth hormone and the solvent and must be used with a Genotropin device. The growth hormone and solvent in the dual-chamber cartridge can be mixed using the Genotropin Pen device.
For both the pre-filled pen GoQuick and the dual-chamber cartridge, dissolve the powder by gently inverting the device until complete dissolution is achieved.
During mixing of Genotropin, DO NOT SHAKE the solution. Mix gently. Shaking may cause foaming and damage the active substance. Check the solution and do not proceed with injection if the solution is cloudy or contains particles.

• Injection of Genotropin: Remember to wash your hands and clean the skin before injection.

Administer the growth hormone injection daily at approximately the same time. It is recommended to inject before going to bed, as it is easier to remember. Also, it is normal to have higher levels of growth hormone during the night.
Most people inject into the thigh or buttock. Inject where your doctor has shown you. The fatty tissue under the skin may decrease at the injection site. To avoid this, always inject in a different spot. This allows the skin and underlying tissue to recover from the previous injection before another injection is given at the same site.
Remember to return Genotropin to the refrigerator immediately after injection.

If you use more Genotropin than you should
If you have injected too high a dose of Genotropin, contact your doctor or pharmacist as soon as possible. Blood sugar levels may drop too low and subsequently rise too high. You may experience tremors, sweating, drowsiness, feel "not yourself," or may faint.

If you forget to use Genotropin
Do not take a double dose to make up for a missed dose.
It is best to take the growth hormone regularly.
If you forget to take a dose, administer the next injection the following day at the usual time. Keep a record of any missed injections and inform your doctor at your next check-up.

If you stop using Genotropin
Ask your doctor for advice before stopping treatment with Genotropin.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Genotropin can cause adverse reactions, although not everyone experiences them. Very common and common adverse reactions in adults may occur within the first months of treatment and may resolve spontaneously or if the dose is reduced.

Very common adverse reactions (may occur in more than 1 out of 10 patients) include:
In adults:

• Joint pain.
• Fluid retention (manifesting as swollen fingers or ankles).

Common adverse reactions (may occur in less than 1 out of 10 patients) include:
In children:

• Joint pain.
• Temporary redness, itching, or pain at the injection site.

In adults:

• Numbness, tingling.
• Pain or burning sensation in the hands or underarms (known as Carpal Tunnel Syndrome).
• Aching in arms and legs, muscle pain.

Uncommon adverse reactions (may occur in less than 1 out of 100 patients) include:
In children:

• Leukemia (reported in a limited number of patients with growth hormone deficiency, some of whom had previously been treated with somatropin. However, there is no evidence that the incidence of leukemia is higher in patients receiving growth hormone without predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting).
• Numbness, tingling.
• Rash.
• Itching.
• Itchy skin eruptions.
• Muscle pain.
• Breast enlargement (gynecomastia).
• Fluid retention (manifesting as swollen fingers or ankles, for a short period at the beginning of treatment).

In adults:

• Breast enlargement (gynecomastia).

Not known: frequency cannot be estimated from available data:

• Type 2 diabetes.
• Facial swelling.
• Headache.
• Decreased blood levels of cortisol hormone.

In children:

• Aching in arms and legs.

In adults:

• Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting).
• Rash.
• Itching.
• Itchy skin eruptions.
• Redness, itching, or pain at the injection site.

Formation of antibodies against injected growth hormone, which however do not appear to block the action of the growth hormone.

The skin around the injection site may become irregular or lumpy, but this should not occur if each injection is given at a different site.

A very rare adverse reaction due to the preservative metacresol is inflammation of the muscles near the injection site. If your doctor observes that you are experiencing this adverse reaction, you should use Genotropin without metacresol.

Rare cases of sudden death have occurred in patients with Prader-Willi Syndrome. However, these cases have not been associated with treatment with Genotropin.

If hip or knee pain or discomfort occurs during treatment with Genotropin, your doctor may consider the possibility of slipped capital femoral epiphysis or Legg-Calvé-Perthes disease.

Other possible adverse reactions related to treatment with growth hormone may include the following. You (or your child) may show elevated blood glucose levels (sugar in the blood) or reduced thyroid hormone levels. This can be monitored by your doctor, who will prescribe appropriate treatment if necessary. Rarely, patients treated with growth hormone have reported inflammation of the pancreas.

If any of the adverse reactions worsen, or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report adverse reactions directly via [appropriate national reporting system, e.g., "reazioni-avverse"].

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GENOTROPIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging in the format Month/Year.
The expiry date refers to the last day of that month.

Before reconstitution:
Store in a refrigerator (+2°C - +8°C). Keep the dual-chamber cartridge in the outer packaging to protect the medicine from light.
Before opening, the product may be removed from the refrigerator and kept at a temperature not exceeding 25°C for a maximum of 1 month, after which it must be discarded.

After reconstitution:
Store in a refrigerator (+2°C - +8°C) for up to 28 days. Do not freeze. Keep the pre-filled pen GoQuick in the outer packaging of the GoQuick pen, or the dual-chamber cartridge in the outer packaging of the Genotropin Pen, to protect the medicine from light.
Do not use the medicine if particles are present in the solution or if it appears cloudy.
Do not freeze or expose Genotropin to extreme cold. If it freezes, do not use it.

Never dispose of needles or empty or partially used cartridges in household waste. After using a needle, dispose of it carefully in a special container for "sharps" provided, so that no one can reuse it or get injured by it.
Never dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Genotropin contains

• The active substance is somatropin*.
• One cartridge contains 5.3 mg or 12 mg of somatropin*.
• After reconstitution, the concentration of somatropin* is 5.3 mg or 12 mg per ml.
• The other components of the powder are: glycine (E640), mannitol (E421), monobasic anhydrous sodium phosphate (E339), dibasic anhydrous sodium phosphate (E339).
• The components of the solvent are: water for injections, mannitol (E421) and metacresol. * Produced by Escherichia coli cells using recombinant DNA technology.

Description of the appearance of Genotropin and contents of the pack
Genotropin is a powder and solvent for solution for injection, supplied in a two-compartment cartridge containing the powder in one compartment and the solvent in the other (5.3 mg/ml or 12 mg/ml). The cartridge may be contained in a pre-filled pen. Packs contain 1 or 5 pre-filled pens, or 1 or 5 or 20 cartridges.
It is possible that not all strengths and pack sizes are marketed.
The powder is white and the solvent is clear.
You may use the cartridges with the pen designed specifically for Genotropin injections. The cartridges of Genotropin are colour-coded and must be used with the corresponding colour-coded Genotropin Pen to ensure correct dosing: the 5.3 mg Genotropin cartridge (blue) must be used with the Genotropin Pen 5.3 (blue). The 12 mg Genotropin cartridge (purple) must be used with the Genotropin Pen 12 (purple). Instructions for use of the device are included in the device packaging. You must request an injection or reconstitution device from your doctor if you do not already have one available.

Marketing Authorization Holder
Pfizer Italia S.r.l.
Via Isonzo 71
04100 Latina
Italy

Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

This medicinal product is authorized in the European Economic Area Member States under the following names:
Genotropin: Austria, Denmark, Finland, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Sweden, United Kingdom
Genotonorm: Belgium, France, Luxembourg
Genotonorm Kabipen: Spain
This leaflet was last approved on:
INSTRUCTIONS FOR USE OF GENOTROPIN GOQUICK
Read these instructions completely before using the GoQuick pen. If you have questions about your dosage or therapy with Genotropin, contact your doctor or nurse.

Information about GoQuick
GoQuick is a pre-filled, multi-dose, disposable injection pen containing 5.3 mg of somatropin. The pen can deliver doses from 0.1 mg to 1.5 mg of Genotropin. Each click of the black ring adjusts the dose by 0.05 mg. Genotropin is mixed only once in the pen, when starting to use a new pen. Never change the cartridges. When the pen is empty, start using a new pen.
The pen stores the dose setting. The dose is set only once on a new pen. The pen allows administration of the same pre-set dose with each injection, thereby preventing administration of a dose higher than the one set.

Important information

• Do not mix the powder and liquid in the pen before attaching a needle.
• Do not store the pen with the needle attached. Genotropin may leak from the pen and air bubbles may form in the cartridge. Always remove the needle and apply the pen cap or needle cover before storage.
• Be careful not to drop the pen. If the pen is dropped and any part appears broken or damaged, do not use it. Contact your doctor or nurse to obtain a replacement pen. If the pen is dropped but appears undamaged, you must repeat the initial preparation procedure described in step 6 (Prepare and use a new GoQuick pen).
• Clean the pen with a damp cloth. Do not immerse the pen in water.
• Always use a new needle for each injection. Do not share pen needles.
• The scale indicating the remaining volume along the side of the cartridge holder shows the amount of Genotropin remaining in the pen.

Storage and disposal

• Store the pen in the refrigerator (between +2 °C and +8 °C) in its outer packaging to protect the medicine from light. Do not freeze or expose the pen to freezing temperatures.
• Do not use the pen after the expiry date.
• 28 days after mixing, discard (dispose of) the pen, even if medicine remains.
• Read the sections of this patient information leaflet relating to storage of the GoQuick pen.
• For disposal of the pen, follow local regulations regarding safety and health. If you are unsure what to do, consult your doctor or nurse.

Components of the GoQuick pen

Needles are not included with the GoQuick pen. You will need to obtain pen needles of maximum length 8 mm from a pharmacy.

• Needles suitable for use with the GoQuick pen: 31 G or 32 G (Becton Dickinson and Company), or 31 G or 32 G (Novo Nordisk), or 32.5 G or 34 G (Terumo)

Prepare and use a new GoQuick pen
Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface:
  o A new GoQuick pen
  o A new needle (not included)
  o A suitable sharps container (not included).
• Check the expiry date printed on the pen label. Do not use the pen if the expiry date has passed.

Step 2 Choose the injection site

• Choose and clean an injection site as recommended by your doctor or nurse. Choose a different site each time you give an injection. Each new injection should be given at least 2 cm away from the previous injection site.
• Avoid bony, bruised, red, painful or hardened areas, and skin areas with scars or skin diseases.

Step 3 Attach the new needle

• Remove the white cap by pulling it off.
• Take a new needle and remove the paper seal.
• Gently push and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage from the pen.
• Leave both caps on the needle.

Step 4 Mix Genotropin

• Hold the pen with the needle pointing upwards and the “A” facing towards you.
• Screw the cartridge holder firmly onto the pen until “B” locks into the groove with a click.
• Gently tilt the pen from side to side to help dissolve the powder completely. Do not shake, as this may damage the growth hormone.
• Check that the liquid in the cartridge is clear and that all powder has dissolved.
  o If the liquid is cloudy or undissolved powder is visible, gently tilt the pen from side to side a few more times.
  o If the liquid remains cloudy or powder is still visible, do not use the pen and try again with a new pen.

Step 5 Remove air from the pen

• Remove the outer needle cap. Keep it to remove the needle after injection.
• Do not remove the inner needle cap. Note: The inner needle cap should be visible after removing the outer cap. If it is not visible, try re-attaching the needle.
• Hold the pen with the needle tip pointing upwards.
• Gently tap the cartridge holder to help any trapped air rise to the top.
• Screw the cartridge holder firmly onto the pen until “C” locks into the groove with a click.
  o Some liquid may appear around the inner needle cap. This is normal.

Step 6 Prepare the pen (priming)

Initial preparation removes any remaining air by expelling a small amount of liquid from the pen. The initial priming dose is 0.1 mg and is different from the dose prescribed by your doctor or nurse. Prime the pen only at first use.

• Remove the inner needle cap and discard it. Caution: do not touch the needle to avoid accidental needle sticks.
• Check that the dose memory window shows 0.1 mg.
• Rotate the grey selector in the direction of the arrows until it stops clicking.
• Hold the pen with the needle pointing upwards.
• Press the blue injection button fully down.
• Check for liquid at the needle tip. If liquid appears, the initial pen preparation is complete.
  o If no liquid appears, repeat the priming steps up to two more times.
  o If still no liquid appears, do not use the pen. Contact your doctor or nurse for advice.

Step 8 Check the dose

The dose on the black mark must be aligned with the white indicator.

• Check that the dose selected at the black mark equals the dose shown in the dose memory window.
  o If the doses match, the pen is ready for injection.
  o If the doses do not match, ensure you have rotated the grey selector in the direction of the arrows until it stops clicking.

Step 9 Administer Genotropin injection

• Hold the pen over the injection site.
• Insert the needle vertically into the skin.
• Press the blue injection button until it stops clicking.
• Wait 5 seconds to ensure the full dose is delivered. While counting, maintain slight pressure on the blue injection button.
• After 5 seconds, remove the needle from the skin.
• Note: If you notice a drop of liquid at the injection site or on the needle tip, at the next injection try holding the blue injection button longer before removing the needle from the skin.

Step 10 Remove the needle

• Carefully cover the needle with the outer needle cap. Caution: do not touch the needle to avoid accidental needle sticks.
• Use the outer needle cap to unscrew the needle.
• Discard (dispose of) the needle in a suitable sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Routine (daily) use of the GoQuick pen
Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface:
  o A pre-mixed GoQuick pen
  o A new needle (not included)
  o A suitable sharps container (not included).
• Check the expiry date printed on the pen label. Do not use the pen if the expiry date has passed.

Do not use the pen 28 days after first use.
Step 2 Choose the injection site

• Choose and clean an injection site as recommended by your doctor or nurse. Choose a different site each time you give an injection. Each new injection should be given at least 2 cm away from the previous injection site.
• Avoid bony, bruised, red, painful or hardened areas, and skin areas with scars or skin diseases.

Step 3 Attach the new needle

• Remove the white cap by pulling it off.
• Take a new needle and remove the paper seal.
• Gently push and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage from the pen.
• Remove both caps from the needle.
  o Keep the outer needle cap to remove the needle after injection.

Step 4 Prepare the dose

• Rotate the grey selector in the direction of the arrows until it stops clicking.
• The dose on the black mark must be aligned with the white indicator.
• Verify that the dose selected at the black mark equals the dose shown in the dose memory window.
  o If the doses match, the pen is ready for injection.
  Note: If the prepared dose is lower, the pen does not contain a complete dose of Genotropin. When a full dose is not available in the pen, follow the instructions provided by your doctor or nurse. Alternatively, contact your doctor or nurse for advice.

Step 5 Administer Genotropin injection

• Hold the pen over the injection site.
• Insert the needle vertically into the skin.
• Press the blue injection button until it stops clicking.
• Wait 5 seconds to ensure the full dose is delivered. While counting, maintain slight pressure on the blue injection button.
• After 5 seconds, remove the needle from the skin.
• Note: If you notice a drop of liquid at the injection site or on the needle tip, at the next injection try holding the blue injection button longer before removing the needle from the skin.

Step 6 Remove the needle

• Carefully cover the needle with the outer needle cap. Caution: do not touch the needle to avoid accidental needle sticks.
• Use the needle cap to unscrew the needle.
• Discard (dispose of) the needle in a suitable sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Use of the needle cover (optional)
The needle cover is an optional accessory supplied separately to conceal the needle during injection.
Apply the needle cover:
Apply the needle cover after step 5 (Prepare and use a new GoQuick pen) to prevent accidental needle sticks.

• Remove the black cap of the needle cover.
  o If the safety shield pops out, push it back into the needle cover until it clicks into place.
• Align the black logo on the needle cover with the blue logo on the pen. Carefully push the needle cover onto the pen until it is securely in place.
• After step 6 (Prepare and use a new GoQuick pen), press the black button to release the safety shield from the needle cover.
• Follow the instructions described in step 7 (Prepare and use a new GoQuick pen).

To remove the needle with the needle cover in place:

• Place the outer needle cap over the end of the safety shield.
• Use the outer needle cap to push the safety shield until it locks into place.
• Use the needle cap to unscrew the needle and discard (dispose of) it in a suitable sharps container.
• Leave the needle cover on the pen.
• Place the black cap on the needle cover. Store the pen in the refrigerator.

To remove the needle cover:

• Remove the needle first, then gently pull the needle cover off the pen.
• Do not discard the needle cover. It can be reused with the next pen.

INSTRUCTIONS FOR USE OF GENOTROPIN GOQUICK

Read these instructions completely before using the GoQuick pen. If you have any questions about the
dosage or Genotropin therapy, contact your doctor or nurse.
Information about GoQuick
GoQuick is a prefilled, multi-dose, disposable injection pen containing 12 mg of
somatropin. The pen can deliver doses from 0.3 mg to 4.5 mg of Genotropin. Each click of the
black ring adjusts the dose by 0.15 mg. Genotropin is mixed only once in the pen, before
starting to use a new pen. Never replace the cartridges. When the pen is empty,
use a new pen.
The pen stores the dose. The dose is set only once on a new pen. The pen
allows administration of the same preset dose at each injection, thereby preventing
administration of a dose higher than the one set.
Important information

• Do not mix the powder and liquid in the pen unless a needle is attached to the pen.
• Do not store the pen with the needle attached. Genotropin may leak from the pen and air bubbles may form in the cartridge. Always remove the needle and apply the pen cap or the needle cap before storage.
• Be careful not to drop the pen. If the pen is dropped and any part appears broken or damaged, do not use it. Contact your doctor or nurse to obtain another pen. If the pen is dropped but is not damaged or broken, the preparation must be repeated as described in step 6 (Prepare and use a new GoQuick pen).
• Clean the pen with a damp cloth. Do not immerse the pen in water.
• Always use a new needle for each injection. Do not share pen needles.
• The scale indicating remaining volume along the side of the cartridge holder shows the amount of Genotropin remaining in the pen.

Storage and disposal

• Store the pen in the refrigerator (between +2 °C and +8 °C) in the outer packaging to protect the medicine from light. Do not freeze or expose the pen to freezing temperatures.
• Do not use the pen after the expiry date.
• 28 days after mixing, discard (dispose of) the pen, even if medicine remains.
• Read the sections of this instruction leaflet dedicated to storage of the GoQuick pen.
• For disposal of the pen, follow local safety and health regulations. If you are unsure what to do, consult your doctor or nurse.

Components of the GoQuick pen

Needles are not included with the GoQuick pen. You will need to obtain pen needles of maximum length 8 mm from a pharmacy.

• Needles to use with the GoQuick pen: either 31 G or 32 G (Becton Dickinson and Company) or 31 G or 32 G (Novo Nordisk) or 32.5 G or 34 G (Terumo)

Prepare and use a new GoQuick pen
Step 1 Preparation

• Wash and dry your hands.
• Gather the following materials and place them on a clean, flat surface: a new GoQuick pen, a new needle (not included), and a suitable sharps container (not included).
• Check the expiry date printed on the pen label. Do not use the pen if the expiry date has passed.

Step 2 Choose the injection site

• Choose and clean an injection site as recommended by your doctor or nurse. Choose a different site each time you give an injection. Each new injection should be given at least 2 cm away from the previous injection site.
• Avoid bony areas, bruised, red, painful or hardened areas, and skin areas with scars or skin diseases.

Step 3 Attach the new needle

• Remove the white cap by pulling it off.
• Take a new needle and remove the paper seal.
• Gently push and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage from the pen.
• Leave both caps on the needle.

Step 4 Mix Genotropin

• Hold the pen with the needle pointing upward and the “A” facing toward you.
• Screw the cartridge holder firmly onto the pen until “B” locks into the groove with a click.
• Gently tilt the pen from side to side to help dissolve all the powder completely. Do not shake, as growth hormone may be damaged.
• Check that the liquid in the cartridge is clear and that all powder is dissolved.
  o If the liquid is cloudy or powder is visible, tilt the pen from side to side a few more times.
  o If the liquid is still cloudy or powder is still visible, do not use the pen and try again with a new pen.

Step 5 Remove air from the pen

• Remove the outer needle cap. Keep it for removing the needle after injection.
• Do not remove the inner needle cap. Note: The inner needle cap should be visible after removing the outer cap. If it is not visible, try reattaching the needle.
• Hold the pen with the needle pointing upward.
• Gently tap the cartridge holder to help any trapped air rise to the top.
• Screw the cartridge holder firmly onto the pen until “C” locks into the groove with a click.
  o Some liquid around the inner needle cap may appear. This is normal.

Step 6 Prepare the pen

Preparation removes any remaining air by expelling a small amount of liquid
from the pen. The preparation dose is 0.3 mg and is different from the dose prescribed by your doctor or
nurse. Prepare the pen only the first time it is used.

• Remove the inner needle cap and discard it. Caution: do not touch the needle to avoid accidental needle sticks.
• Check that the dose memory window shows 0.3 mg.
• Turn the grey selector in the direction of the arrows until it stops clicking.
• Hold the pen with the needle pointing upward.
• Press the purple injection button fully down.
• Check for liquid at the needle tip. If liquid appears, pen preparation is complete.
  o If no liquid appears, repeat the preparation steps up to two more times.
  o If no liquid still appears, do not use the pen. Contact your doctor or nurse for guidance.

Step 7 Set and prepare the dose

On first use of the pen, you will set the dose prescribed by your doctor or nurse.
It is not necessary to reset the dose until you start using a new pen or until instructed otherwise by your doctor or nurse.

• Turn the black ring counterclockwise until the dose aligns with the white indicator in the dose memory window. Be careful not to turn the grey selector.
  o If you turn the ring past the white indicator, turn the black ring backward to set the correct dose. Note: If you cannot turn the ring, press the purple injection button until it stops clicking. Then try setting the dose again. Liquid will come out of the needle.
• Turn the grey selector in the direction of the arrows until it stops clicking.

Step 8 Check the dose

The dose on the black mark must be aligned with the white indicator.

• Check that the dose selected on the black mark matches the dose set in the dose memory window.
  o If the doses match, the pen is ready for injection.
  o If the doses do not match, ensure that you have turned the grey selector in the direction of the arrows until it stops clicking.

Step 9 Administer the Genotropin injection

• Hold the pen over the injection site.
• Insert the needle vertically into the skin.
• Press the purple injection button until it stops clicking.
• Wait 5 seconds to ensure the full dose is delivered. While counting, maintain slight pressure on the purple injection button.
• After 5 seconds, remove the needle from the skin in a straight motion. Note: If you see a drop of liquid at the injection site or on the needle tip, at the next injection try holding the purple injection button pressed longer before removing the needle from the skin.

Step 10 Remove the needle

• Carefully cover the needle with the outer needle cap. Caution: do not touch the needle to avoid accidental needle sticks.

Routine (daily) use of the GoQuick pen
Step 1 Preparation

• Wash and dry your hands.
• Gather the following supplies and place them on a clean, flat surface:
  o A pre-mixed GoQuick pen
  o A new needle (not included)
  o A proper sharps container (not included).
• Check the expiration date on the pen label. Do not use the pen if the expiration date has passed. Do not use the pen more than 28 days after first use.

Step 2 Choose the injection site

• Choose and clean an injection site as recommended by your doctor or nurse. Select a different site each time you give an injection. Each new injection should be given at least 2 cm away from the previous injection site.
• Avoid bony areas, bruised, red, sore or hardened skin, and areas with scars or skin diseases.

Step 3 Attach the new needle

Remove the white cap by pulling it off.

• Take a new needle and remove the paper seal.
• Gently push and then screw the needle onto the pen. Do not overtighten. Note: Be careful not to attach the needle at an angle, as this may cause leakage from the pen.
• Remove both needle caps. Keep the outer needle cap for removing the needle after injection.

Step 4 Prepare the dose

Turn the grey selector in the direction of the arrows until it stops clicking.
The dose on the black mark must align with the white indicator.
Verify that the dose shown at the black mark matches the dose set in the dose memory window.
If the doses match, the pen is ready for injection.
Note: If the prepared dose is lower, the pen does not contain a full dose of Genotropin.
When a full dose is not available in the pen, follow the instructions provided by your doctor or nurse. Alternatively, contact your doctor or nurse for guidance.

Step 5 Inject Genotropin

Hold the pen over the injection site.
Insert the needle vertically into the skin.
Press the purple injection button until it stops clicking.
Wait 5 seconds to ensure the full dose is delivered. While counting, maintain light pressure on the purple injection button.
After 5 seconds, remove the needle from the skin with a straight motion.
Note: If you see a drop of liquid at the injection site or on the needle tip, at the next injection try holding the purple injection button down longer before removing the needle from the skin.

Step 6 Remove the needle

• Carefully cover the needle with the outer needle cap. Caution: do not touch the needle to avoid accidental needle sticks.
• Use the needle cap to unscrew the needle.
• Dispose of the needle in a proper sharps container.
• Replace the white cap on the pen.
• Store the pen in the refrigerator until the next injection.

Use the needle cover (optional)

The needle cover is an optional accessory provided separately to hide the needle during injection. Attach the needle cover:
Attach the needle cover after Step 5 (Prepare and use a new GoQuick pen) to prevent accidental needle sticks.

• Remove the black cap of the needle cover.
  o If the needle shield comes out of position, push it back into the needle cover until it clicks into place.
• Align the black logo on the needle cover with the purple logo on the pen. Carefully push the needle cover onto the pen until it is securely in place.
• After Step 6 (Prepare and use a new GoQuick pen), press the black button to release the needle shield from the needle cover.
• Follow the instructions described in Step 7 (Prepare and use a new GoQuick pen).

To remove the needle with the needle cover in place:

• Place the outer needle cap over the end of the needle shield.
• Use the outer needle cap to push the needle shield until it locks into place.
• Use the needle cap to unscrew the needle and dispose of it in a proper sharps container.
• Leave the needle cover on the pen.
• Replace the black cap on the needle cover. Store the pen in the refrigerator.

To remove the needle cover:

• First remove the needle, then gently remove the needle cover from the pen.
• Do not dispose of the needle cover. It can be reused with the next pen.