Genotropin Kabiven 5.3 mg powder and solvent for solution for injection: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GENOTONORM KABIPEN 5.3 mg and 12 mg powder and solvent for injectable solution

somatropin

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

What Genotonorm Kabipen is and what it is used for
What you need to know before using Genotonorm Kabipen
How to use Genotonorm Kabipen
Possible side effects
How to store Genotonorm Kabipen

Pack contents and additional information

1. What Genotonorm Kabipen is and what it is used for

Genotonorm Kabipen is a recombinant human growth hormone (also known as somatropin). It has the same structure as human growth hormone, which is necessary for the growth of bones and muscles. It also helps muscle and fat tissues develop in appropriate amounts. The term "recombinant" means that it is not derived from human or animal tissue.

In children, Genotonorm Kabipen is used to treat growth disorders:

If the child is not growing properly or does not produce enough of their own growth hormone.
In cases of Turner syndrome. Turner syndrome is a chromosomal disorder that occurs in girls and may affect growth—your doctor will determine whether this condition is present.
In cases of chronic kidney insufficiency. If the kidneys lose their ability to function properly, growth may be impaired.
In cases of Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help the child grow if they are still in a growth phase, and will also improve body composition. Excess fat will decrease and loss of muscle mass will improve.
In cases of being born small or with low birth weight. Growth hormone may help the child grow if they have not yet achieved or maintained normal growth by the age of 4 years or later.

In adults, Genotonorm Kabipen is used to treat individuals with a pronounced deficiency of growth hormone. This deficiency may begin in adulthood or may have started in childhood and continue into adulthood.

If you have been treated with Genotonorm Kabipen for growth hormone deficiency during childhood, your growth hormone status should be reevaluated after completion of the growth phase. If severe growth hormone deficiency is confirmed, your doctor will recommend continuing treatment with Genotonorm Kabipen.

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

2. What you need to know before starting to use Genotonorm Kabipen

Do not use Genotonorm Kabipen and contact your doctor if

You are allergic (hypersensitive) to somatropin or to any of the other components of Genotonorm Kabipen.
You have an active tumor (cancer). Tumors must be inactive and anti-tumor treatment must have been completed before starting treatment with Genotonorm.
You are seriously ill (e.g., complications following open-heart surgery, abdominal surgery, acute respiratory failure, accidental trauma, or a similar condition). If you are about to undergo or have recently undergone major surgery or are to be admitted to hospital for any reason, inform your doctor and remind all other physicians examining you that you are using growth hormone.
You have completed your growth phase (closed epiphyses) and Genotonorm Kabipen was prescribed to stimulate growth.

Use special caution with Genotonorm Kabipen and contact your doctor

If you are at risk of developing diabetes, your doctor will monitor your blood sugar levels during treatment with Genotonorm Kabipen.
If you have diabetes, you must carefully monitor your blood sugar levels during treatment with Genotonorm Kabipen and review the results with your doctor to determine whether your diabetes medication dosage needs to be adjusted.
After starting treatment with Genotonorm Kabipen, some patients may need to begin treatment with thyroid hormone.
If you are receiving thyroid hormone therapy, the dose of thyroid hormone may need to be adjusted.
If you are receiving growth hormone treatment to stimulate growth and you develop a limp, or start limping due to hip pain during treatment with growth hormone, you must inform your doctor.
If increased intracranial pressure occurs (with symptoms such as severe headaches, vision problems, or vomiting), inform your doctor immediately.
If your doctor confirms that you have developed inflammation of the muscles near the injection site due to the preservative metacresol, you should switch to another formulation of Genotonorm that does not contain metacresol.
If you are receiving Genotonorm Kabipen for growth hormone deficiency following a previous tumor (cancer), you should undergo periodic evaluations for possible tumor recurrence or other cancers.
If you experience abdominal pain that becomes more severe, inform your doctor.
Experience with patients over 80 years of age is limited. Elderly patients may be more sensitive to the effects of Genotonorm Kabipen and therefore may be more prone to developing adverse effects.

Children with chronic renal insufficiency:

Your doctor will assess your kidney function and growth rate before starting treatment with Genotonorm Kabipen. Medical treatment for your kidney disease must continue. Treatment with Genotonorm Kabipen should be discontinued in the event of a kidney transplant.

Children with Prader-Willi syndrome:

Your doctor will provide dietary restrictions to help you manage your weight.
Your doctor will perform an examination before starting treatment with Genotonorm Kabipen to determine whether you have upper airway obstruction, sleep apnea (when breathing stops during sleep), or respiratory infections.
If during treatment you develop signs of upper airway obstruction (including new or worsening snoring), your doctor will need to examine you and may discontinue treatment with Genotonorm Kabipen.
During treatment, your doctor will monitor for any signs of scoliosis, a type of spinal deformity.
If during treatment you develop a lung infection, inform your doctor so that you can be treated for the infection.

Children born small or with low birth weight:

If you were born small or with low birth weight and are between 9 and 12 years old, consult your doctor specifically about puberty and treatment with this product.
Your doctor will perform blood tests for sugar and insulin before starting treatment and once a year during treatment.
Treatment should continue until your growth phase ends.

Use in athletes

This medicine contains somatropin, which may result in a positive doping test.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Genotonorm.

If you are receiving glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need adjustment.

Inform your doctor if you are taking:

Medications for the treatment of diabetes
Thyroid hormones
Synthetic adrenal hormones (corticosteroids)
Orally administered estrogens or other sex hormones
Cyclosporine (a medication that suppresses the immune system after transplantation)
Medications for epilepsy control (anticonvulsants)

Your doctor may need to adjust the dose of these medications or the dose of Genotonorm Kabipen.

Pregnancy and breastfeeding

Do not use Genotonorm Kabipen if you are pregnant, think you might be pregnant, or are trying to become pregnant.

Consult your doctor before using this medicine during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Genotonorm Kabipen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".

3. How to use Genotonorm Kabipen

Recommended dose

The dose depends on your body surface area, the medical condition being treated, and how your growth hormone functions. Each person is different. Your doctor will determine your individualized dose of Genotonorm Kabipen in milligrams (mg), based either on your body weight in kilograms (kg) or on your body surface area calculated from your height and weight in square meters (m²), as well as your treatment schedule. Do not change either the dose or the treatment schedule without consulting your doctor.

Children with growth hormone deficiency:

0.025–0.035 mg/kg body weight per day or 0.7–1.0 mg/m² body surface area per day. Higher doses may be used. When growth hormone deficiency continues into adolescence, treatment with Genotonorm Kabipen should be continued until physical development is complete.

Children with Turner syndrome:

0.045–0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day.

Children with chronic renal insufficiency:

0.045–0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day. If growth velocity is too low, higher doses may be necessary. Dose adjustment may be required after 6 months of treatment.

Children with Prader-Willi syndrome:

0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day. The daily dose must not exceed 2.7 mg. This treatment should not be used in children whose growth phase has nearly ended after puberty.

Children born small for gestational age with growth disorders:

0.035 mg/kg body weight per day or 1.0 mg/m² body surface area per day. It is important to continue treatment until final height is reached. Treatment should be discontinued after the first year if there is no response, or if final height has been achieved and growth has ceased.

Adults with growth hormone deficiency:

If continuing Genotonorm treatment from childhood, start with a dose of 0.2–0.5 mg per day. This dose should be gradually increased or decreased based on laboratory results, clinical response, and adverse effects.

If growth hormone deficiency begins in adulthood, treatment should start at 0.15–0.3 mg per day. This dose should be gradually increased depending on laboratory results, clinical response, and adverse effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men. Dosing should be monitored every 6 months. Patients over 60 years of age should start with doses of 0.1–0.2 mg per day and increase slowly according to individual needs. Use the lowest effective dose. The maintenance dose rarely exceeds 0.5 mg per day. Follow the instructions provided by your doctor.

Injection of Genotonorm Kabipen

This medicine is administered subcutaneously. This means it is injected with a small needle into the fatty tissue just beneath the skin. Your doctor will show you how to use it. Always use the medicine exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.

Instructions for use of the pre-filled device GoQuick are also provided in the GoQuick device box.

Instructions for using Genotonorm Kabipen in a dual-chamber vial together with the Genotonorm Pen are provided in the injection device case.

Please consult these instructions before using your medicine.

When using a pre-filled device or a Genotonorm Pen injection device, you must attach a needle to the device before mixing. Always use a new needle for each injection. Needles must not be reused.

Preparation of the injection:

You may remove the medicine from the refrigerator half an hour before injection. This allows it to reach room temperature slightly, making the injection more comfortable.

The pre-filled GoQuick device contains a dual-chamber vial containing the growth hormone and liquid solvent. The growth hormone and liquid solvent are mixed by rotating the vial (see detailed steps in the Instructions for Use). No additional device is needed.

Genotonorm is also available in a dual-chamber vial containing the growth hormone and liquid solvent for use with the Genotonorm Pen device. The growth hormone and liquid solvent in the dual-chamber vial can be mixed by screwing the Genotonorm Pen device together.

In both cases—whether using the pre-filled GoQuick device or the dual-chamber vial—dissolve the powder by gently tilting until the powder is completely dissolved.

When mixing Genotonorm Kabipen, DO NOT SHAKE the solution. Mix gently. Shaking may cause foaming of the growth hormone and damage the medicine. Inspect the solution and do not inject if you notice cloudiness or particles in it.

Injection of Genotonorm Kabipen:

Remember to wash your hands first and clean the skin at the injection site.

Inject your growth hormone at the same time every day. A good time is bedtime, as it is easy to remember. It is also normal to have higher levels of growth hormone at night.

Most patients use the thighs or buttocks for injection. Inject at the site your doctor has shown you. The fatty tissue under the skin may decrease in size at the injection site. To prevent this, change the injection site each time. This allows the skin and underlying tissue time to recover between injections before returning to the same site.

Remember to store the medicine in the refrigerator immediately after injection.

If you use more Genotonorm Kabipen than you should

If you inject more than you should, contact your doctor or pharmacist immediately. Blood sugar levels may drop sharply and later rise to excessively high levels. You may feel restless, sweaty, drowsy, or strange, and you may experience dizziness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 5620420, indicating the medicine and the amount ingested.

If you forget to administer Genotonorm Kabipen

Do not administer a double dose to make up for missed doses.

It is best to inject the growth hormone regularly. If you miss a dose, administer the next injection at the usual time the following day. Record any missed injections and inform your doctor at your next visit.

If you interrupt treatment with Genotonorm Kabipen

Consult your doctor before interrupting treatment with this medicine.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent and very frequent adverse effects in adults may begin during the first months of treatment and may disappear spontaneously or when the dose is reduced.

Very common adverse effects (may affect more than 1 in 10 patients) include:

In adults:

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

Common adverse effects (may affect up to 1 in 10 patients) include:

In children:

Joint pain.
Redness, itching, or temporary pain at the injection site.

In adults:

Numbness/tingling.
Pain or burning sensation in the hands or armpits (known as carpal tunnel syndrome).
Stiffness in arms and legs, muscle pain.

Uncommon adverse effects (may affect up to 1 in 100 people) include:

In children:

Leukemia (reported in a small number of patients with growth hormone deficiency, some of whom have received treatment with somatropin. However, there is no evidence that the incidence of leukemia is increased in growth hormone recipients without predisposing factors).
Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
Numbness/tingling.
Rash.
Itching.
Itchy skin hives.
Muscle pain.
Breast enlargement (gynecomastia).
Fluid retention (manifested as swollen fingers or swollen ankles, for a short period at the beginning of treatment).

In adults:

Breast enlargement (gynecomastia).

Frequency not known: cannot be estimated from available data:

Type II diabetes.
Facial swelling.
Headache.
Decreased blood concentrations of cortisol hormone.

In children:

Stiffness in arms and legs.

In adults:

Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
Rash.
Itching.
Itchy skin hives.
Redness, itching, or pain at the injection site.

Development of antibodies against the injected growth hormone, although this does not appear to affect the hormone's action.

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

The preservative metacresol may very rarely cause inflammation of the muscles near the injection site. If your doctor confirms that you have developed this adverse effect, you should use Genotonorm without metacresol.

Rare cases of sudden death have been reported in patients with Prader-Willi syndrome. However, no causal relationship has been established between these cases and treatment with this medicine.

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

Other possible side effects related to growth hormone treatment are as follows.

You (or your child) may experience increased blood sugar levels or decreased thyroid hormone concentrations. Your doctor may perform tests to monitor this and, if necessary, prescribe appropriate treatment. Pancreatitis has occasionally been reported in patients treated with growth hormone.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaRAM.es.

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

5. Storage of Genotonorm Kabipen

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging as MM/YYYY. The expiry date refers to the last day of the month indicated.

Before reconstitution

Store in a refrigerator (2ºC–8ºC). Keep the dual chamber vial in the outer packaging to protect it from light.

Before opening, the medicine may be kept outside the refrigerator for a maximum period of 1 month at a temperature not exceeding 25ºC; however, after this period it must be discarded.

After reconstitution

Store in a refrigerator (2ºC–8ºC) for a maximum of 28 days. Do not freeze. Keep the prefilled device GoQuick in the outer packaging, or the dual chamber vial in the injection device case, to protect it from light.

Do not use this medicine if you observe particles or if the solution appears cloudy.

Never freeze or expose this medicine to ice. If it has been frozen, do not use it.

Never dispose of needles or empty vials in the regular household waste. Once you have used a needle, it should be carefully discarded into a special sharps container so that no one can reuse it or get pricked.

Medicines must not be disposed of via wastewater or in regular household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Genotonorm Kabipen

The active substance is somatropin*.
A vial 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), anhydrous sodium hydrogen phosphate (E339), and anhydrous disodium dihydrogen phosphate (E339) (see section 2 “Genotonorm Kabipen contains sodium”).
The ingredients of the solvent are: water for injections, mannitol (E421), and metacresol.

*Obtained from Escherichia coli cells by recombinant DNA technology.

Appearance of Genotonorm Kabipen and contents of the pack

Powder and solvent for solution for injection, in a dual-chamber vial containing the powder in one compartment and the solvent in the other (5.3 mg/ml or 12 mg/ml). The vial may be supplied in a pre-filled device. Pack sizes: 1 or 5 pre-filled device(s), or 1, 5, or 20 vial(s).

Only certain pack sizes may be marketed.

The powder is white and the solvent is clear.

The vials must be used with a specific Genotonorm Kabipen injection device. Genotonorm Kabipen vials have a colour code and must be used with the matching colour-coded Genotonorm Kabipen injection device to ensure correct dosing: the Genotonorm Kabipen 5.3 mg vial (blue) must be used with the Genotonorm Kabipen 5.3 injection device (blue). The Genotonorm Kabipen 12 mg vial (violet) must be used with the Genotonorm Kabipen 12 injection device (violet).

Instructions for use of the device are included in its packaging. If you do not have an injection device, please ask your doctor.

Marketing Authorisation Holder

Pfizer, S.L.

Avda. de Europa 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid), Spain.

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Genotropin: Austria, Denmark, Finland, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Sweden, United Kingdom (Northern Ireland).

Genotonorm: Belgium, France, Luxembourg.

Genotonorm Kabipen: Spain.

Date of the most recent review of this leaflet: May 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

INSTRUCTIONS FOR USE OF GENOTONORM KABIPEN GOQUICK®

Read these instructions completely before using the GoQuick device.

If you have any questions about the dose or treatment with Genotonorm, contact your doctor or nurse.

About GoQuick

GoQuick is a pre-filled, multi-dose, disposable injection device containing 5.3 mg of somatropin. The device can deliver doses from 0.1 mg to 1.5 mg of medication. Each click of the black wheel changes the dose by 0.05 mg. The Genotonorm vial inside the device is mixed only once, when you start using a new device. You must never replace the vial. When the device is empty, you must begin using a new one.

The device has dose memory. The dose is set each time you start using a new device. After that, the device allows you to prepare the same set dose for each injection. This will prevent you from drawing a dose larger than the one set.

Important Information

Do not mix the powder and liquid in the device unless you have a needle attached.
Do not store the device with the needle attached. Medication may leak from the device and air bubbles may form in the vial. Always remove the needle and place the device cap or needle shield cap before storing.
Take care not to drop the device. If the device is dropped and any part appears broken or damaged, do not use it. Contact your doctor or nurse to obtain a replacement. If the device is dropped but not damaged or broken, you must perform another purge as described in Step 6 (Preparation and use of a new GoQuick device).
Clean the device with a damp cloth. Do not immerse the device in water.
Always use a new needle for each injection. Do not share needles between devices.
The remaining volume scale along the side of the vial holder is a guide to show the amount of medication remaining in the device.

Storage and Disposal

Store the device in the refrigerator (between 2 °C and 8 °C) in the outer packaging to protect it from light. Do not freeze or expose to frost.
Do not use the device after its expiration date.
Dispose of (discard) the device 28 days after mixing, even if some medication remains.
Refer to the reverse side of this leaflet for information on how to store the GoQuick device.

Follow local health and safety regulations for disposal (discarding) of the device. Ask your doctor or nurse if you are unsure what to do.

Parts of the GoQuick Device

Medical diagram showing parts of an injection device, components of the

Needles for the device are not included with the GoQuick device. You will need to obtain needles for devices up to 8 mm in length from your pharmacy.

Needles compatible with the GoQuick device:

31 G or 32 G (Becton Dickinson and Company)
31 G or 32 G (Novo Nordisk®)
32.5 G or 34 G (Terumo)

Preparation and Use of a New GoQuick Device

(-:Step 1. )=100%(Step 1. :-) (-:Attach the Needle )=89%(Preparation

A hand holding a Genotropin injection pen with a magnified view showing detail of the

(-:Pull the white pen cap straight off the pen.)=74%(Wash and dry your hands.
Place the following items on a clean, flat surface:

One new GoQuick device
One new needle (not included)
An appropriate sharps container (not included)

Check the expiration date on the device label. Do not use the device if it has passed its expiration date.

(-:Push the needle onto the cartridge holder tip.)=81%((-:Do not overtighten.)=100%(

(-:Leave both needle covers on the needle.)=0%(<0}

{0>Step 2. <}100{>Step 2. <0} {0>Mix the Genotropin <}0{>Select the injection site <0}

Medical diagram showing the trunk and legs of a person with two gray areas on the thighs and a magnified view highlighting the application sites

{0>Hold the pen with the needle pointing up and A facing you.<}87{> Select and clean the injection site as recommended by your doctor or nurse. Choose a different site each time an injection is given. Each new injection should be administered at least 2 cm away from the previous injection site.
Avoid bony, bruised, red, painful, or hard areas, and areas of skin with scars or skin conditions.

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Step 3. Attach a new needle <0}

Hands rotating a cap onto a medical device with blue arrows and a crossed circle indicating not to remove the component

- {0>Pull the outer needle cover off.<}0{>Remove the white cap from the device by pulling straight off.
Take a new needle and remove its paper seal.
Gently insert and then screw the needle onto the device. Do not overtighten.

Note: Be careful not to attach the needle at an angle. This may cause leakage from the device.

Keep both needle covers on the needle.

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Step 4. Mix the contents of the Genotonorm vial <0}

Diagram with three stages showing how to rotate a medical device from position A to position B with an audible click

{0>Hold the pen in one hand below the green logo.<}0{>Hold the device with the needle pointing upward and “A” facing you.
Turn the vial holder firmly until “B” clicks into the notch.
Gently tilt the device from side to side to help completely dissolve the powder. Do not shake. Shaking may damage the growth hormone.
Check that the liquid in the vial is clear and that all powder is dissolved.

If the liquid is cloudy or you see powder, gently tilt the device from side to side several more times.
If the liquid remains cloudy or you still see powder, do not use the device and try again with a new one.

Step 5. Remove air from the device

Diagram with three steps: remove the cap, rotate the device, and reach position C with a click indicated in a magnified view

Remove the outer needle cover. Keep it to remove the needle after injection.
Leave the inner needle cover on.

Note: You should see an inner needle cover after removing the outer cover. If you do not, try reattaching the needle.

Hold the device with the needle pointing upward.
Gently tap the vial holder to bring trapped air to the top.
Firmly turn the vial holder on the device until “C” clicks into the notch.
- A small amount of liquid may appear around the inner needle cover. This is normal.

Step 6. Prime the device

Three illustrated steps: remove the cap, rotate the device dial, and press the button for the

Priming removes any remaining air by pushing a small amount of liquid out of the device. The initial dose is 0.1 mg and differs from the dose prescribed by your doctor or nurse. Prime the device only the first time you use it.

Remove the inner needle cover and discard it.

Caution: Do not touch the needle to avoid accidental needlestick.

Check that the memory window is set to 0.1 mg.
Turn the grey dial in the direction of the arrows until it stops clicking.
Hold the device with the needle pointing upward.
Press the blue injection button fully down.
Check for liquid at the needle tip. If liquid appears, the device is primed.
- If no liquid appears, repeat the priming steps up to two more times.
- If liquid still does not appear, do not use the device. Contact your doctor or nurse for advice.

Step 7. Set and prepare your dose

Diagram with instructions to rotate a black wheel and a gray dial on a medical device with numerical indicators and directional arrows

The first time you use the device, you will set the dose prescribed by your doctor or nurse.

There is no need to reset the dose until you start using a new device or until your doctor or nurse instructs you otherwise.

Turn the black wheel counterclockwise until your dose aligns with the white indicator in the memory window. Be careful not to turn the grey dial.

If you turn past your dose, rotate the black wheel backward to set the correct dose.

Note: If you cannot turn the black wheel, press the blue injection button until it stops clicking. Then try adjusting your dose again. Note that liquid will come out of the needle.

Turn the grey dial in the direction of the arrows until it stops clicking.

Step 8. Check your dose

Close-up of a medical device with two blue circular indicators showing the value 1.3 on a numbered scale

Your dose must be aligned with the white indicator.

Check that the dose set on the black ring matches the dose set in the memory window.

If the doses match, the device is ready to administer the injection.
If the doses do not match, ensure that you have turned the grey dial in the direction of the arrows until it stops clicking.

Step 9. Administer the Genotonorm Kabipen injection

Diagram with three phases: insert the

Hold the device over the injection site.
Insert the needle straight into the skin.
Press the blue injection button fully down until it stops clicking.
Wait a full 5 seconds to ensure the complete dose is delivered. Continue to gently press the blue injection button while counting.
After 5 seconds, remove the needle straight out of your skin.

Note: If you see a drop of liquid at the injection site or on the needle tip, for the next injection try pressing the blue injection button a little longer before removing the needle from the skin.

Step 10 Remove the needle

Technical illustration showing the

Carefully cover the needle with its outer cap.
Caution: Do not touch the needle to avoid accidental needlestick injury.
Use the needle cap to unscrew the needle.
Dispose of the needle in an appropriate sharps container.

Press the white cap onto the device.

Store the device in the refrigerator until the next injection.

Regular (daily) use of the GoQuick device

Step 1 Preparation

A hand holding a Genotropin 5.3 mg/ml injection pen with a circular magnification showing the detail of the batch and expiration date section

Wash and dry your hands.
Place the following items on a clean, flat surface:

One new GoQuick device
One new needle (not included)
An appropriate sharps container (not included)

Check the expiration date on the device label. Do not use the device if it has passed its expiration date. Do not use the device 28 days after first use.

Step 2 Choose the injection site

Medical diagram showing the trunk and legs of a person with two gray areas on the thighs and a magnified view highlighting the injection sites

Choose and clean the injection site as recommended by your doctor or nurse. Select a different site each time you administer 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 hard areas, and areas of skin with scars or skin conditions.

Step 3 Attach a new needle

Two hands rotating the top part of an injection pen to the right with blue arrows and a prohibited symbol indicating not to do so

Remove the white cap from the device by pulling straight off.
Take a new needle and remove the paper seal.
Gently insert and then screw the needle onto the device. Do not overtighten.
Note: Be careful not to attach the needle at an angle. This may cause leakage from the device.
Remove both needle caps.
- Keep the outer needle cap to remove the needle after injection.

Step 4 Prepare your dose

Two illustrations showing a hand rotating the dial of a medical device to set the dosage to 1.3 units and verify it

Turn the grey dial in the direction of the arrows until it stops clicking.
Your dose shown in the black ring should be aligned with the white indicator.

Check that the drawn-up dose in the black ring matches the dose set in the memory window.

If the dose matches, the device is ready to administer the injection.

Note: If the drawn-up dose is lower, the device does not contain a full dose of Genotonorm.

Follow the instructions provided by your doctor or nurse if a full dose is not available in the device. Alternatively, contact your doctor or nurse for advice.

Step 5 Administer the Genotonorm Kabipen injection

Diagram with three phases: insert the

Hold the device over the injection site.
Insert the needle directly into the skin.
Press the blue injection button until it stops clicking.
Wait a full 5 seconds to ensure the full dose is delivered. Continue to gently press the blue injection button while counting.
After 5 seconds, remove the needle from your skin straight out.

Note: If you see a drop of liquid at the injection site or on the needle tip, for the next injection try pressing the blue injection button for a longer time before removing the needle from the skin.

Step 6 Remove the needle

Technical illustration showing the rotational movement of a vial to separate the cap from the container body using a blue arrow

Carefully cover the needle with its outer cap.

Caution: Do not touch the needle to avoid accidental needlestick injury.

Use the outer needle cap to unscrew the needle.
Dispose (throw away) the needle into an appropriate sharps container.

Replace the white cap onto the device.
Store the device in the refrigerator until the next injection.

Three illustrated instructions for the Use of the needle cover (optional)

The needle cover is an optional accessory supplied separately to conceal the needle during injection.

Attaching the needle cover:

Attach the needle cover after step 5 (Adjustment and use of a new GoQuick device) to avoid accidental needle sticks.

Remove the black cap from the needle cover.

If the needle shield slides outward, 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 device. Carefully push the needle cover onto the device until it clicks into place.
After step 6 (Preparation and use of a new GoQuick device), press the black button to release the needle cover shield.

Follow the instructions described in step 7 (Preparation and use of a new GoQuick device).

To remove the needle with the needle cover attached:

Place the outer needle cap over the end of the needle cover.
Use the outer needle cap to push the needle cover forward until it clicks into place.
Use the needle cover to unscrew the needle and dispose of it in an appropriate sharps container.
Leave the needle cover attached to the device.
Place the black cap onto the needle cover. Store the device in the refrigerator.

To remove the needle cover:

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

INSTRUCTIONS FOR USE OF GENOTONORM KABIPEN GOQUICK®

Read these instructions in full before using the GoQuick device.

If you have any questions about the dose or treatment with Genotonorm Kabipen, contact your doctor or nurse.

About GoQuick

GoQuick is a prefilled, multidose, disposable injection device containing 12 mg of somatropin. The device can deliver doses of Genotonorm Kabipen ranging from 0.3 mg to 4.5 mg. Each click of the black wheel changes the dose by 0.15 mg. The Genotonorm vial built into the device is mixed only once, when you begin using a new device. You must never replace the vial. When the device is empty, you must start using a new one.

The device has dose memory. The dose is set each time a new device is used. Afterwards, the device allows you to prepare the same preset dose for each injection. This will prevent you from drawing a dose larger than the one set.

Important information

Do not mix the powder and liquid in the device unless you have a needle attached to the device.
Do not store the device with the needle attached. The medication may leak from the device and air bubbles may form in the vial. Always remove the needle and replace either the device cap or the needle cover before storing.
Avoid dropping the device. If the device is dropped and any part appears broken or damaged, do not use it. Contact your doctor or nurse to obtain a replacement device. If the device is dropped but not damaged or broken, perform another purge as described in Step 6 (Preparation and use of a new GoQuick device).
Clean the device with a damp cloth. Do not immerse the device in water.
Always use a new needle for each injection. Do not share needles between devices.
The remaining volume scale along the side of the vial holder is a guide to show the amount of medication left in the device.

Storage and disposal

Store the device in the refrigerator (between 2 °C and 8 °C) inside the outer packaging to protect it from light. Do not freeze or expose to freezing temperatures.
Do not use the device after its expiration date.
Dispose of (throw away) the device 28 days after mixing, even if some medication remains.
Refer to the reverse side of this leaflet for further information on how to store the GoQuick device.
Follow local health and safety regulations for disposal of the device. Ask your doctor or nurse if you are unsure what to do.

Parts of the GoQuick device

Medical diagram showing parts of an injection device with labels in Spanish, including syringe, needle, cap, and release button

Device needles are not included with the GoQuick device. You will need to obtain device needles up to 8 mm in length from your pharmacy.

Needles compatible with the GoQuick device:

31 G or 32 G (Becton Dickinson and Company)
31 G or 32 G (Novo Nordisk®)
32.5 G or 34 G (Terumo)

Preparation and use of a new GoQuick device

Step 1 Preparation

A hand holding a 12 mg Genotropin syringe with a magnified view showing the

Wash and dry your hands.
Place the following items on a clean, flat surface:

One new GoQuick device
One new needle (not included)
An appropriate sharps container (not included)

Check the expiration date on the device label. Do not use the device if it has passed its expiration date.

Step 2 Choose the injection site

Human body diagram showing the thigh areas highlighted in gray for the

Choose and clean the injection site as recommended by your doctor or nurse. Select a different site each time an injection is administered. Each new injection should be given at least 2 cm away from the previous injection site.
Avoid bony, bruised, red, painful, or hard areas, and areas of skin with scars or skin conditions.

Step 3 Attach a new needle

Two hands rotating a white cap onto a medical device with purple arrows indicating movement and a no-symbol prohibiting the action

- Remove the white cap from the device by pulling straight off.
Take a new needle and remove the paper seal.
Gently insert and then screw the needle onto the device. Do not overtighten.

Note: Be careful not to attach the needle at an angle. This may cause leakage from the device.

Leave both needle covers in place.

Step 4. Mix the contents of the Genotonorm vial

Diagram with three phases: Position A with notch facing down, rotating the device by hand, and Position B with notch facing up

Hold the device with the needle pointing upward and the “A” facing you.
Turn the vial holder firmly until “B” clicks into place.
Gently tilt the device from side to side to help completely dissolve the powder. Do not shake. Shaking may damage the growth hormone.
Check that the liquid in the vial is clear and that all the powder has dissolved.

If the liquid is cloudy or you see powder, gently tilt the device from side to side several more times.
If the liquid remains cloudy or any powder is still visible, do not use the device; discard it and try again with a new device.

Step 5. Remove air from the device

Diagram with three steps: remove the cap, rotate the device, and place into position C with indication of an audible click

Remove the outer needle cap. Keep it for removing the needle after injection.
Leave the inner needle cap in place.

Note: After removing the outer cap, you should see an inner needle cap. If you do not, try attaching the needle again.

Hold the device with the needle pointing upward.
Gently tap the vial holder to allow trapped air to rise to the top.
Firmly turn the vial holder into the device until “C” clicks into place.
A small amount of liquid may appear around the inner needle cap. This is normal.

Step 6. Prime the device

Three illustrated steps: remove the cap, rotate the graduated dial, and press the button with the hand holding the

Priming removes any remaining air by expelling a small amount of liquid from the device. The initial dose is 0.3 mg and is different from the dose prescribed by your doctor or nurse. Prime the device only the first time you use it.

Remove the inner needle cap and discard it.

Caution: Do not touch the needle to avoid accidental needlestick.

Check that the memory window is set to 0.3 mg.
Turn the grey dial in the direction of the arrows until it stops clicking.

Hold the device with the needle pointing upward.
Press the purple injection button fully down.
Check the tip of the needle for liquid. If liquid appears, the device is primed.

If no liquid appears, repeat the priming steps up to two more times.
If liquid still does not appear, do not use the device. Contact your doctor or nurse for advice.

Step 7. Set and prepare your dose

Diagram with instructions to rotate the black wheel and gray dial of a medical device with dosage indications in milligrams

The first time you use the device, you will set the dose prescribed by your doctor or nurse.

There is no need to readjust the dose until you start using a new device or your doctor or nurse instructs you otherwise.

Turn the black wheel counterclockwise until your prescribed dose aligns with the white indicator in the memory window. Be careful not to turn the grey dial.

If you turn past your dose, rotate the black wheel backward to correctly align your dose.

Note: If you cannot turn the black wheel, press the purple injection button until it stops clicking, then try adjusting the dose again. Note that liquid may come out of the needle.

Turn the grey dial in the direction of the arrows until it stops clicking.

Step 8. Check your dose

Close-up of a medical device with two circular windows showing the dosage of 1.5 mg on a white and gray graduated scale

Your dose should be aligned with the white indicator.

Check that the dose displayed on the black ring matches the dose set in the memory window.

If the doses match, the device is ready to administer the injection.
If the doses do not match, ensure that you have turned the grey dial in the direction of the arrows until it stops clicking.

Step 9. Administer the Genotonorm Kabipen injection

Diagram with three phases: insert the injection pen into the skin, inject the medication, and wait 5 seconds as indicated by the

Hold the device over the injection site.
Insert the needle straight into the skin.
Press the purple injection button fully down until it stops clicking.
Wait a full 5 seconds to ensure the complete dose is delivered. Continue to gently press the purple injection button while counting.
After 5 seconds, remove the needle from your skin straight out.

Note: If you see a drop of liquid at the injection site or on the needle tip, for your next injection try pressing the purple injection button a little longer before removing the needle from the skin.

Step 10. Remove the needle

Illustration of a hand rotating a syringe cap to the left to unscrew or close the medical device

Carefully cover the needle with its outer cap.
Caution: Do not touch the needle to avoid accidental needlestick.
Use the needle cap to unscrew the needle from the device.
Dispose of the needle in an appropriate sharps container.

Press the white cap onto the device.
Store the device in the refrigerator until the next injection.

Regular (daily) use of the GoQuick device
Step 1 Preparation Wash and dry your hands. Place the following items on a clean, flat surface: One new GoQuick device One new needle (not included) An appropriate sharps container (not included) Check the expiration date on the device label. Do not use the device if it has passed its expiration date. Do not use the device more than 28 days after first use.
Step 2 Choose the injection site Choose and clean the injection site as recommended by your doctor or nurse. Select a different site each time you administer an injection. Each new injection should be given at least 2 cm away from the previous injection site. Avoid bony, bruised, red, painful or hard areas, and areas of skin with scars or skin conditions. Step 3 Attach a new needle Remove the white cap from the device by pulling straight off. Take a new needle and remove the paper seal. Gently insert and then screw the needle onto the device. Do not overtighten. Note: Be careful not to attach the needle at an angle. This may cause leakage from the device. Remove both needle covers. Keep the outer needle cover for removing the needle after injection.
Step 4 Prepare your dose
Turn the grey dial in the direction of the arrows until it stops clicking. Your dose shown in the black ring should be aligned with the white indicator. Check that the dose drawn up in the black ring matches the dose set in the memory window. If the doses match, the device is ready to administer the injection. Note: If the drawn-up dose is lower, the device does not contain a full dose of Genotonorm. Follow the instructions provided by your doctor or nurse if a full dose is not available in the device. Alternatively, contact your doctor or nurse for advice.
Step 5 Administer the Genotonorm Kabipen injection Hold the device over the injection site. Insert the needle directly into the skin. Press the violet injection button until it stops clicking. Wait a full 5 seconds to ensure the complete dose is injected. Continue to gently press the violet injection button while counting. After 5 seconds, remove the needle from your skin straight out. Note: If you see a drop of liquid at the injection site or on the needle tip, for your next injection try pressing the violet injection button for a longer time before removing the needle from the skin.
Step 6 Remove the needle
Carefully cover the needle with its outer cover. Caution: Do not touch the needle to avoid accidental needlestick. Use the needle cover to unscrew the needle. Dispose (throw away) the needle into an appropriate sharps container. Press the white cap back onto the device. Store the device in the refrigerator until the next injection. Use of the needle cover (optional) The needle cover is an optional accessory sold separately to hide the needle during injection. Attaching the needle cover: Attach the needle cover after Step 5 (Setting up and using a new GoQuick device) to avoid needlestick injury. Remove the black cap from the needle cover. If the needle shield slides out, push it back into the needle cover until it clicks into place. Align the black logo on the needle cover with the violet logo on the device. Carefully push the needle cover onto the device until it clicks into place. After Step 6 (Preparing and using a new GoQuick device), press the black button to release the shield of the needle cover. Follow the instructions described in Step 7 (Preparing and using a new GoQuick device). To remove the needle with the needle cover attached: Place the outer needle cover on the end of the needle cover. Use the outer needle cover to push the needle cover until it clicks into place. Use the needle cover to unscrew the needle and dispose (throw away) it in an appropriate sharps container. Leave the needle cover on the device. Place the black cap on the needle cover. Store the device in the refrigerator. To remove the needle cover: First remove the needle, then gently remove the needle cover from the device. Do not dispose of the needle cover. It can be reused with your next device.