Genotropin Miniquick 1.6 mg powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GENOTONORM 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 solution for injection

somatropin

Read the entire leaflet carefully before you start using this medicine, because 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 you should not give it to others, even if they have the same symptoms as you, because it could 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:

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

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

Genotonorm Miniquick 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 ensure that fatty and muscle tissues develop in appropriate amounts. The term "recombinant" means that it is not derived from human or animal tissue.

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

• If the child is not growing adequately or does not produce enough of their own growth hormone.
• In cases of Turner syndrome. Turner syndrome is a chromosomal disorder affecting girls and may impair growth – your doctor will determine whether this condition is present.
• In cases of chronic renal 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 achieved or maintained normal growth by the age of 4 years or later.

In adults, Genotonorm Miniquick 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 Miniquick for growth hormone deficiency during childhood, your growth hormone status should be re-evaluated after completion of the growth phase. If severe growth hormone deficiency is confirmed, your doctor may recommend continuing treatment with Genotonorm Miniquick.

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 using Genotonorm Miniquick

Do not use Genotonorm Miniquick and contact your doctor if

• You are allergic (hypersensitive) to somatropin or to any of the other components of Genotonorm Miniquick.
• You have an active tumor (cancer). Tumors must be inactive and antitumor 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 similar conditions). 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 examining physicians that you are using growth hormone.
• You have completed your growth period (closed epiphyses) and Genotonorm Miniquick was prescribed to stimulate growth.

Take special care with Genotonorm Miniquick and contact your doctor

• If you are at risk of developing diabetes, your doctor will monitor your blood sugar levels during treatment with Genotonorm Miniquick.
• If you have diabetes, you must carefully monitor your blood sugar levels during treatment with Genotonorm Miniquick and review the results with your doctor to determine whether your diabetes medication dosage needs adjustment.
• After starting treatment with Genotonorm, some patients may need to begin treatment with thyroid hormone.
• If you are receiving thyroid hormone therapy, it may be necessary to adjust the dose of thyroid hormone.
• If you are being treated with growth hormone to stimulate growth and you limp, or begin to limp due to hip pain during growth hormone treatment, inform your doctor.
• If increased intracranial pressure occurs (with symptoms such as severe headaches, vision problems, or vomiting), inform your doctor immediately.
• If you are receiving Genotonorm Miniquick due to growth hormone deficiency following a previous tumor (cancer), you should undergo periodic evaluations for possible tumor recurrence or any other cancer.
• If you experience abdominal pain that becomes more severe, inform your doctor.
• Experience in patients over 80 years of age is limited. Elderly patients may be more sensitive to the effects of Genotonorm Miniquick 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 Miniquick. Medical treatment for your kidney disease must continue. Treatment with Genotonorm Miniquick should be discontinued in case of kidney transplantation.

Children with Prader-Willi syndrome:

• Your doctor will provide dietary restrictions to help you control your weight.
• Your doctor will perform an examination before starting treatment with Genotonorm Miniquick 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 interrupt treatment with Genotonorm Miniquick.
• 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 appropriate treatment can be provided.

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 test in doping controls.

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 must consult your doctor regularly, as your glucocorticoid dosage 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 dosage of these medications or the dosage of Genotonorm Miniquick.

Pregnancy and breastfeeding

Do not use Genotonorm 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 Miniquick 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 Miniquick

Recommended dose

The dose depends on your body surface area, the condition for which you are being treated, and how your growth hormone functions. Each person is different. Your doctor will determine your individualized dose of Genotonorm Miniquick 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 during adolescence, treatment with Genotonorm 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. Higher doses may be necessary if growth velocity is too low. A 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 practically ended after puberty.

Small-for-gestational-age children 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 you continue using Genotonorm Miniquick after childhood treatment, start with a dose of 0.2–0.5 mg per day. This dose should be gradually increased or decreased according to 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 based on laboratory results, clinical response, and adverse effects. The daily maintenance dose rarely exceeds 1.0 mg. 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. The lowest effective dose should be used. The maintenance dose rarely exceeds 0.5 mg per day. Follow the instructions provided by your doctor.

Injection of Genotonorm Miniquick

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

Please read the "Instructions for use" at the end of this leaflet for information on how to use Genotonorm Miniquick. If you cannot remember how to do it, do not attempt to administer the injection. Ask your doctor to show you again.

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

Remember to wash your hands and clean your skin before injecting.

Administer your growth hormone injection at the same time every day. An ideal 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 their thighs or buttocks for injection. Inject in the area your doctor has shown you. The fatty tissue under the skin may decrease in size at the injection site. To avoid this, change the injection site each time. This allows the skin and underlying tissue time to recover between injections before using the same spot again.

If you use more Genotonorm Miniquick than you should

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

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 medication and the amount ingested.

If you forget to administer Genotonorm Miniquick

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

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 check-up.

If you stop treatment with Genotonorm Miniquick

Consult your doctor before stopping treatment with Genotonorm Miniquick.

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

4. Possible adverse effects

Like all medicines, Genotonorm Miniquick may cause adverse effects, although not everyone experiences them.

Frequent and very common 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 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 patients) include:

In children:

• Leukaemia (reported in a small number of patients with growth hormone deficiency, some of whom received treatment with somatropin. However, there is no evidence that the incidence of leukaemia is increased in recipients of growth hormone in the absence of predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
• Numbness/tingling.
• Rash.
• Itching.
• Itchy skin welts (urticaria).
• Muscle pain.
• Breast enlargement (gynaecomastia).
• Fluid retention (manifested as swollen fingers or ankle swelling, occurring for a short period at the beginning of treatment).

In adults:

• Breast enlargement (gynaecomastia).

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 welts (urticaria).
• 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 rough and irregular, but this should not occur if the injection is given at a different site each time.

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 Genotonorm Miniquick.

If you experience hip or knee pain or discomfort while receiving Genotonorm treatment, 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 include:

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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for 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 Miniquick

Keep out of the 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 (2°C–8°C). Do not freeze. Keep the syringe in the outer packaging to protect it from light.

Before opening, the product may be stored outside the refrigerator for a maximum period of 6 months at temperatures not exceeding 25°C. The date when the medicine is removed from refrigeration and the new expiry date must be recorded on the outer packaging. This new expiry date must never exceed the original expiry date stated on the outer packaging. If the medicine has not been used before this new expiry date, it must be discarded.

After reconstitution

Use immediately or store in a refrigerator (2°C–8°C) for a maximum of 24 hours. Do not freeze. Keep the syringe in the outer packaging to protect it from light.

Do not use this medicine if you notice particles or if the solution is not clear.

Never dispose of needles or empty syringes in household waste. After use, needles should be carefully discarded into a special sharps container to prevent accidental injury or reuse.

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

6. Package contents and other information

Composition of Genotonorm Miniquick

• The active substance is somatropin*.
• One vial 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 of somatropin* in 0.25 ml after reconstitution, corresponding to a concentration of 0.8 mg, 1.6 mg, 2.4 mg, 3.2 mg, 4.0 mg, 4.8 mg, 5.6 mg, 6.4 mg, 7.2 mg, and 8.0 mg/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 Miniquick contains sodium”).
• The ingredients of the solvent are: water for injections and mannitol (E421).

*Obtained from Escherichia coli cells by recombinant DNA technology.

Appearance of Genotonorm Miniquick 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 (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 vial is contained in a syringe. Pack sizes: 4, 7, or 28 syringes.

Only certain pack sizes may be marketed.

The powder is white and the solvent is clear.

Marketing Authorization 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 authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

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

Genotonorm Miniquick: Belgium, France, Luxembourg, 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 MINIQUICK

Genotonorm Miniquick is a syringe designed to mix and administer a single dose of Genotonorm (growth hormone).

Genotonorm Miniquick is supplied pre-filled with a dual-chamber vial and a needle. If you require additional needles, please request the same Becton Dickinson Micro-fine needles supplied with Miniquick. The injection volume is always 0.25 ml.

Genotonorm Miniquick is for single use only; after administering the dose, dispose of it as described in step 6.

The illustration below identifies its different components.

The Genotonorm Miniquick vial contains growth hormone powder in one chamber and solvent in the other. When the plunger is rotated clockwise, the growth hormone powder and solvent mix and the powder dissolves.

1. Remove the paper covering the injection needle. Firmly attach the needle until it reaches the rubber stopper. Rotate the Genotonorm Miniquick needle clockwise until it can no longer turn.

1. Hold Genotonorm Miniquick with the needle pointing upwards. Rotate the plunger clockwise until it stops.

DO NOT SHAKE the solution. Mix gently. Shaking may cause foaming of the growth hormone and damage the active substance. Check that the solution is clear; use only clear solutions free from particles.

1. Remove both the outer and inner needle caps.

1. Firmly pinch the skin at the injection site and insert the needle.

1. Inject by pressing the plunger fully to deliver the entire contents of Genotonorm Miniquick. Wait a few seconds before removing the needle to ensure all the growth hormone is injected.

1. After injection, do not attempt to recap the needle. Dispose of the syringe with the needle attached, along with the outer and inner caps, according to standard procedures or as instructed by your doctor or pharmacist.

QUESTIONS AND ANSWERS

Question Is it a problem if I see air bubbles in the syringe? What should I do if there is resistance when turning the plunger (step 2) or during injection (step 5)? What should I do if the needle becomes damaged or bent?

Answer No. It is not necessary to remove the air from the Genotonorm Miniquick syringe. The small amount of air in the syringe does not affect the injection. Resistance may be due to the needle being inserted at an angle into the rubber stopper. Carefully place the outer protective cap (the one that is opaque white) over the needle and turn it counterclockwise to remove the needle. Hold the Miniquick syringe with the end where the needle attaches facing upward, and place a new needle straight onto the end of the syringe. Screw the needle onto the syringe. Dispose of the damaged needle and use a new one with Miniquick.