Zomacton 10 mg/ ml polvo y disolvente para solucion inyectable

Package Insert: Information for the User

Zomacton 10 mg/ml Powder and Diluent for Injectable Solution

Somatropin

Read this package insert carefully before starting to use the medicine because it contains important information for you.Thispackage insertis for your information only.

• Keep this package insert, 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 should not be given to others, even if they have the same symptoms, as it may harm them. If you experience any side effects, consult your doctor or pharmacist. Even if they are not listed in this package insert. See section 4.

The information in this package insert refers to you or a child or adolescent in your care.

Zomacton contains the active ingredient somatropin, also known as growth hormone. Growth hormone is naturally produced in the body. It has a very important function in growth. Zomacton contains somatropin obtained in a pharmaceutical manufacturing facility.

Zomacton is used for the long-term treatment of:

• Growth problems due to the absence of growth hormone in children;
• Growth problems due to Turner Syndrome (a genetic disorder affecting women).

Do not use Zomacton

• In children when bone growth is complete (epiphyseal closure)
• Do not use Zomacton and inform your doctor if you have an active tumor (cancer). Tumors must remain inactive and treatment for the tumor must be completed before starting Zomacton treatment
• If you are allergic to any of the components of Zomacton or to any of the ingredients of this medication (listed in section 6)
• If you are seriously ill due to the following complications: open-heart or abdominal surgery, multiple trauma from an accident, or respiratory failure
• In children with chronic kidney disease after kidney transplantation

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zomacton.

Zomacton treatment should only be initiated under the supervision of a specialist doctor, with experience in diagnosing patients with growth hormone deficiency.

• Zomacton contains a preservative called metacresol. In very rare cases, the presence of metacresol may cause inflammation (swelling) of the muscles. If you experience muscle pain or pain at the injection site, inform your doctor.
• Patients with Prader-Willi syndrome should not be treated with Zomacton unless they also have growth hormone deficiency.
• If you have a family history ofdiabetes mellitus, your blood sugar levels should be regularly checked by your doctor.
• If you arediabetic, you will require strict control of your blood glucose levels and your dose may need to be adjusted to maintain diabetic control. Your doctor will inform you if necessary.

• If your growth hormone deficiency is caused by a problem in your brain (intracranial lesion), you should be frequently examined to evaluate possible worsening or recurrence of the disease. If this is confirmed, your doctor will inform you if you need to interrupt Zomacton treatment.
• If you have had a serious illness, such as cancer, Zomacton treatment may cause the disease to recur or worsen. Therefore, if you experience any symptoms that concern you, you should consult your doctor immediately.
• If you are receiving glucocorticoid replacement therapy, you should consult your doctor regularly as your dose of glucocorticoid may need to be adjusted.
• Zomacton treatment may lead to thyroid hormone deficiency, which may require treatment. To control it, your doctor will perform regular checks to ensure that your thyroid gland is functioning correctly.
• Some children with growth hormone deficiency have developed leukemia (an increase in the number of white blood cells in the blood), whether or not they have received growth hormone treatment. However, there is no evidence that the incidence of leukemia is increased in patients without risk factors treated with growth hormone. No cause-and-effect relationship with growth hormone treatment has been proven.
• If you suffer from complications after surgery, trauma, or acute respiratory failure.
• If you require surgery, are seriously injured in an accident, or are seriously ill, your doctor will review your treatment.
• Consider pancreatitis in children treated with somatropin who develop abdominal pain.
• Zomactonmay cause pancreatitis, which causes intense pain in the abdomen and back. If you, or your child, develop stomach pain after administering Zomacton, consult your doctor.

If you develop any of the following while on treatment with Zomacton, contact your doctor or nearest assistance department urgently:

• repeated or intense headaches
• vision problems
• nausea and/or vomiting

Please consult your doctor immediately if you develop limping or pain in the hip, knee, or thigh.

Use in athletes

This medication contains somatropin, which may produce a positive result in doping control tests.

Use of other medications and Zomacton

Inform your doctor or pharmacist:

• If you are being treated with steroids due to insufficient production of ACTH (adrenocorticotropic hormone). This is because your steroid dose will normally need to be adjusted while on Zomacton treatment.
• If you are being treated with high doses of androgens, estrogens, and anabolic steroids, as they may reduce the final height gain.
• If you are being treated with regularly prescribed medication, such as steroids, epilepsy medication, or immunosuppressive medication.
• If you are being treated with insulin,your dose may need to be adjusted to maintain diabetic control. Your doctor will inform you if necessary.

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

Pregnancy and lactation

Zomacton should not be used during pregnancy or during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Zomacton has no influence on the ability to drive or operate machinery.

Follow exactly the administration instructions for Zomacton as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor or nurse will inform you of the correct dose for you. The dose is administered via subcutaneous injection (under the skin) using a syringe.

Dosage:

Growth Hormone Deficiency in Children:

Your doctor will calculate the exact dose for you, based on your body weight in kilograms (kg). Generally, a dose of 0.17 – 0.23 mg per kg of body weight per week is recommended. This weekly amount can be divided into six or seven doses, corresponding to a daily dose of 0.02 – 0.03 mg per kg of body weight. The maximum recommended weekly dose is 0.27 mg per kg of body weight, equivalent to daily doses of up to approximately 0.04 mg per kg of body weight.

Turner Syndrome (only in women):

Your doctor will calculate the exact dose for you, based on your body weight. A dose of 0.33 mg per kg of body weight per week is generally recommended. This weekly amount can be divided into six or seven doses, equivalent to a daily dose of 0.05 mg per kg of body weight.

Reconstitution Instructions:

Zomacton is provided as a powder and should only be mixed with the provided solvent (liquid).

The 10 mg/ml solution for injection is prepared by mixing the Zomacton powder with 1 ml of solvent using a pre-loaded syringe as described below.

1.Wash your hands.

2. Remove the yellow plastic cap from the vial.

3. The top of the vial should be cleaned with an antiseptic solution or alcohol to prevent contamination of the contents. Do not touch the rubber stopper of the vial after cleaning.

4. Take the pre-loaded syringe with solvent. Remove the gray cap. Attach the reconstitution needle to the syringe. Remove the cap from the needle.

5. Place the needle in the center of the rubber stopper of the cleaned vial and inside the vial, and slowly inject the solvent into the vial, directing the liquid stream against the glass wall to prevent foam formation.

6. Discard the syringe in a sharp object disposal container.

7. Gently rotate the vial a few times until the contents are completely dissolved. Do not agitate.

8. If the solution is cloudy or contains particles, do not use it. If cloudiness persists after refrigeration, let the product reach room temperature. If cloudiness persists, discard the vial and its contents.

The contents should be clear and colorless after reconstitution.

Reconstitution with a standard syringe:

Step 5.

The vial should then be gently rotated until the powder is completely dissolved, forming a clear and colorless solution.

Place the reconstituted Zomacton vial in a vertical position in the refrigerator at 2°C to 8°C.

Avoid shaking or vigorously mixing. If the solution remains cloudy or contains particles, the vial and its contents should be discarded. If cloudiness persists after refrigeration, wait for the solution to reach room temperature. If cloudiness persists, discard the vial and its contents.

Administration:

The required dose of Zomacton 10 mg/ml is administered using a standard syringe as shown by your healthcare professional in the clinic.

After reconstitution, the following steps should be taken for injection.

1.Wash your hands.

2. Clean the top of the vial with an alcohol swab to prevent contamination of the contents. Do not touch the rubber stopper after cleaning.

3. Place the vial upside down, keeping the top of the needle below the surface of the medication. Gently pull the plunger until the prescribed amount of medication fills the syringe. If there is not enough medication for a complete dose, reconstitute a new vial to compensate for the difference.

4. With the needle still in the vial, gently tap the syringe to loosen any air bubbles.

5. Remove the needle from the vial and carefully replace the needle cap until you are ready to inject.

6. Thoroughly clean the injection site with alcohol.

7. Check that the syringe contains the correct dose.

8. Remove the needle cap and hold the syringe as you would hold a pencil.

9. With your free hand, gently pinch the skin around the injection site between your fingers.

10. Insert the needle into the tissue under the skin surface at an angle of 45° to 90° to reduce discomfort.

11. Holding the syringe in place, pull the plunger back (if blood appears in the syringe, it means you have entered a blood vessel. Do not inject ZOMACTON. Remove the needle, discard all supplies, and go back to step 1. Choose and clean a new injection site). If no blood appears, slowly push the plunger until the syringe is empty.

12. Quickly remove the needle and apply pressure to the injection site with a sterile gauze. Discard the needle and syringe in a sharp object disposal container.

Do not share your syringes, needles, or vials with anyone else. You may infect them or contract an infection from them. Any unused product or waste must be disposed of in accordance with local regulations.

Do not share your syringes, needles, or vials with anyone else. You may infect them or contract an infection from them.

Any unused product or waste must be disposed of in accordance with local regulations.

If you use more Zomacton than you should:

A overdose may cause low blood sugar (hypoglycemia) and subsequently high blood sugar (hyperglycemia).

If you or someone else has used more Zomacton than they should, contact your doctor or nearest hospital immediately. The effects of repeated overdose are unknown. Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to use Zomacton:

If you forget a dose, do not worry. Continue normally and administer the next dose at your usual time.

Do not use a double dose to compensate for the missed dose.

You may experience hypoglycemia (low blood sugar) that may cause dizziness, confusion, and blurred vision. Although long-term treatment effectiveness will not be affected, you should consult your doctor if this happens.

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Like all medicines, Zomacton can cause side effects, although not everyone will experience them.

The injection of growth hormone under the skin may cause weight gain or loss, as well as bruising and hematoma (purple skin discoloration) at the injection site. Therefore, it is recommended to change the injection site frequently. In rare cases, patients developed skin pain or itching at the injection site.

Very common side effects,that affect more than 1 in 10 patients treated:Only adults:

• Swelling due to fluid retention, especially in the hands and feet (Edema)
• Mildly increased blood sugar levels (hyperglycemia)
• Joint pain (Arthralgia)
• Muscle pain (Myalgia)
• Headache
• Numbness, tingling, burning, or crawling sensation on the skin (Paresthesia)

Common side effects,that affect between 1 and 10 in every 100 patients treated:Children and adults:

• Hypothyroidism
• Immune reaction to growth hormone, which may appear in a blood test (formation of antibodies)
• Headache
• Increased muscle tone (hypertonia)

Only children:

• Swelling due to fluid retention, especially in the hands and feet (Edema, peripheral edema)
• Reactions at the injection site
• Weakness (Asthenia)
• Modified glucose tolerance
• Joint pain (Arthralgia)
• Muscle pain (Myalgia)

Only adults:

• Rigidity in the legs and/or arms
• Difficulty falling asleep and/or difficulty staying asleep (Insomnia)

Rare side effects, that affect between 1 and 10 in every 1,000 patients treated:

Children and adults:

• Anemia
• High heart rate (Tachycardia)
• Sensation of spinning (Vertigo)
• Dual vision (Diplopia)
• Papilledema (swelling of the optic disc)
• Vomiting, abdominal pain, flatulence, nausea
• Weakness
• Atrophy at the injection site, bleeding at the injection site, swelling at the injection site, hypertrophy
• Low blood sugar levels (Hypoglycemia)
• Hyperphosphatemia (elevated phosphate levels in the blood)
• Muscle atrophy
• Bone pain
• Carpal tunnel syndrome
• Malignant neoplasia, neoplasia
• Drowsiness
• Involuntary eye movements (Nystagmus)
• Personality disorders
• Urinary incontinence, hematuria (blood in the urine), polyuria (increased urine volume), increased frequency of urination, urinary anomalies
• Reactions at the injection site (including lipodystrophy, skin atrophy, exfoliative dermatitis, urticaria, hirsutism, skin hypertrophy)
• Enlargement of the breasts (Gynecomastia)

Only children:

• Rigidity in the legs and/or arms

Only adults:

• High blood pressure (Hypertension)

Rare side effects, that affect between 1 and 10 in every 10,000 patients treated:

Children and adults:

• Diarrhea
• Abnormal renal function tests
• Type 2 diabetes mellitus
• Numbness or tingling in certain areas of the body (Neuropathy)
• Fluid retention around the brain (manifests as repeated or intense headache, blurred vision, and/or nausea and/or vomiting)

Only children:

• High blood pressure (Hypertension)
• Difficulty falling asleep and/or difficulty staying asleep (Insomnia)
• Numbness, tingling, burning, or crawling sensation on the skin (Paresthesia)

Very rare side effects, that affect less than 1 in every 10,000 patients treated:

Only children:

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationoutofsightandoutofthereachofchildren.

Do not use Zomacton after the expiration date indicated on the packaging (EXP).The expiration date is the last day of the month indicated.

Store in a refrigerator at2°C-8°C; store in the original packaging to protect it from light.

Once the powder has been dissolved in the provided solvent (reconstituted), store the vial in an upright position at 2° C and 8° C (in a refrigerator).

After reconstitution, the solution must be used within 28 days. Any remaining solution in the vial must be discarded at the end of this period.

In the event of turbidity after refrigeration, the solution should be allowed to reach room temperature. If turbidity persists or coloration appears, discard the vial and its contents.

Medications should not be disposed of through drains or in the trash.Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of empty packaging and unused medications. This will help protect the environment.

Composition of Zomacton

The active ingredient is somatropin 10 mg (10 mg/ml after reconstitution).

The other components are:

Powder: Mannitol, disodium dodecahydrate phosphate, dihydrogen sodium phosphate dihydrate.

Solvent: Injection water and metacresol

What Zomacton looks like and contents of the pack.

The product is a powder and solvent for injectable solution.

The powder is provided in a vial and the solvent in a syringe. The powder is white to off-white in color. When dissolved in the provided solvent, a clear and transparent solution is formed.

Zomacton is available in packs of 1, 3 and 5 and contains:

10 mg of somatropin in a vial and 1 ml of solvent in a syringe.

All packs may not be marketed.

Marketing Authorization Holder:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Responsible for manufacturing:FERRING GmbH

Wittland 11, D-24109 Kiel

GERMANY

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria ZOMACTON 10 mg/ml – Powder and solvent for the preparation of an injection solution

BelgiumZOMACTON 10 mg/ml

DenmarkZOMACTON 10 mg

FinlandZOMACTON 10 mg/ml

FranceZomacton 10 mg/ml

GermanyZOMACTON 10 mg/ml

GreeceZOMACTON 10 mg

IrelandZOMACTON 10 mg

ItalyZOMACTON 10 mg

LuxembourgZOMACTON 10 mg/ml

NetherlandsZOMACTON 10 mg/ml

PortugalZOMACTON 10 mg

SpainZOMACTON 10 mg

SwedenZOMACTON 10 mg/ml

United Kingdom (Northern Ireland)ZOMACTON 10 mg

This text was approved in September 2021.

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