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ZOMACTON is a brand name for Somatropin (also known as Somatotropin). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Zomacton® is indicated for the long-term treatment of children who have growth failure due to inadequate secretion of growth hormone and for the long-term treatment of growth retardation due to Turner’s Syndrome confirmed by chromosome analysis.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology ZOMACTON therapy should be used only under the supervision of a qualified physician experienced in the management of patients with growth hormone deficiency. The dosage and schedule of administration of ZOMACTON should be individualised for each patient.
The duration of treatment, usually a period of several years, will depend on maximum achievable therapeutic benefit. c. 0 mg/m2 body surface area). 04 mg/kg). c. 63 mg/m2/body surface area). Method of administration The required ZOMACTON dose is administered by using the Ferring-Pen (a needle device) or alternatively a conventional syringe.
Specific instructions for use of the Ferring-Pen are given in a brochure supplied with the device. The clear, colourless solution should then be administered subcutaneously. Following reconstitution, the following steps should be performed for injection 1.
Hands should be washed. 2. The top of the vial should be wiped with an alcohol swab to prevent contamination of the content. Do not touch the rubber stopper after cleaning. 3. Turn the vial upside down keeping the top of the needle below the surface of the medication.
Gently pull back on the plunger until your prescribed amount of medication fills the syringe. If you do not have enough medication for a full dose, reconstitute a new vial to make up the difference. 4. With the needle still in the upside down vial, gently tap the syringe to loosen any air bubbles.
5. Remove the needle from the vial and carefully replace the needle cap until ready to inject. 6. Thoroughly clean the injection site with an alcohol swap. 7. Check that the correct dose is in the syringe. 8. Remove the needle cap and hold the syringe the way you 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 beneath the skin’s surface at a 45° to 90° angle to reduce discomfort. 11. Holding the syringe in place, pull back (if there is blood in the syringe, it means you have entered a blood vessel.
Do not inject ZOMACTON. Withdraw 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 pull the needle straight out and apply pressure to the site of injection with a sterile gauze pad.
The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue at the injection site. On rare occasions patients have developed pain and an itchy rash at the site of injection. System Organ Class Very Common (≥ 1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000, to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000 ) Blood and lymphatic system disorders anemia Cardiac disorders tachycardia, (adult) hypertension (children) hypertensi on Ear and labyrinth disorders vertigo Endocrine disorders hypothyroidism Eye disorders papilloedem a, diplopia Gastrointestina l disorders vomiting, abdominal pain, flatulence, nausea diarrhoea General disorders and administration site conditions (adults) oedema, (adults) peripheral oedema (children) oedema, (children) peripheral oedema, injection site reactions, asthenia weakness, injection site atrophy, injection site haemorrhage , injection site mass, hypertrophy Immune system disorders antibody building Investigations renal function test abnormal Metabolism and nutrition disorders (adult) mild hyperglyca (children) glucose tolerance hypoglycae mia, hyperphosph diabetes mellitus type II emia impaired atemia Musculoskeleta l and connective tissue disorders (adults) arthralgia; (adults) myalgia (children) arthralgia; (children) myalgia (Adults) Stiffness in the extremities muscle atrophy, bone pain, carpal tunnel syndrome (Children) Stiffness in the extremities Neoplasms benign, malignant and unspecified neoplasm malignant, neoplasm (children) leukaemia Nervous system disorders (adult) headache, (adult) paresthesia headache, hypertonia, (adult) insomnia somnolence, nystagmus neuropathy , intracranial pressure increased, (children) insomnia, (children) paresthesia Psychiatric disorders personality disorders Renal and urinary disorders urinary incontinence , haematuria, polyuria, urine frequency/po llakiuria, urine abnormality Reproductive system and breast disorders genital discharge, gynecomasti a Skin and subcutaneous tissue disorders lipodystroph y, skin atrophy, dermatitis exfoliative, urticaria, hirsutism, skin hypertrophy Pancreatitis has been reported post-marketing during GH therapy (frequency unknown).
2). Due to the presence of benzyl alcohol as excipient, ZOMACTON may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates. ZOMACTON is not indicated for the long term treatment of paediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome, unless they also have a diagnosis of GH deficiency.
There have been reports of sleep apnoea and sudden death after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea or unidentified respiratory infection.
Rare cases of benign intra-cranial hypertension have been reported. In the event of severe or recurring headache, visual problems, and nausea/vomiting, a funduscopy for papilla edema is recommended. 8). At present, there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension.
If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary. Leukaemia has been reported in a small number of growth hormone deficient patients treated with somatropin as well as in untreated patients.
However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposition factors. As with all somatropin containing products, a small percentage of patients may develop antibodies to somatropin.
The binding capacity of these antibodies is low and there is no effect on growth rate. Testing for antibodies to somatropin should be carried out in any patient who fails to respond to therapy. Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask incipient hypothyroidism.
1 Zomacton must not be given to premature babies or neonates as the solvent contains benzyl alcohol. Zomacton must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumor therapy must be completed prior to starting GH therapy.
Treatment should be discontinued if there is evidence of tumour growth. Zomacton should not be used for growth promotion in children with closed epiphyses. Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions should not be treated with Zomacton.
In children with chronic renal disease, treatment with Zomacton should be discontinued at renal transplantation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Throw away the needle and syringe in your sharps disposable container. Do not share your syringes, needles, or vials with anyone else. You may give them an infection or get one from them. The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue at the injection site.
Therefore, injection sites should be alternated. 6.
Antibodies anti-somatropin: the protein somatropin may give rise to the formation of antibodies. Depending on the concerned product, these antibodies have been identified in a definite percentage of the treated population. Their binding capacity and their titres are generally low with no clinical consequence.
However, testing for antibodies to somatropin should be performed in case of absence of response to somatropin therapy. Leukaemia: cases of leukaemia (very rare) have been reported in children with a GH deficiency, some of them being treated with somatropin and included in the post-marketing experience.
However, there is no evidence of an increased risk of leukaemia without predisposition factors. Slipped capital femoral epiphysis and Legg-Calve-Perthes disease have been reported in children treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calve-Perthes is more frequent in case of short stature.
But, it is unknown if these 2 pathologies are more frequent or not while treated with somatropin. A discomfort, a pain in the hip and/or the knee must evocate their diagnosis. Other adverse drug reactions may be considered as class effect, as the hyperglycaemia due to the decrease in insulin-sensitivity, the decreased of free thyroxin level and the possible development of a benign intra-cranial hypertension.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Monitoring of thyroid function should therefore be conducted in all patients. In patients with hypopituitarism, standard replacement therapy must be closely monitored when somatropin therapy is administered. Because somatropin may reduce insuline sensitivity , patients should be monitored for evidence of glucose intolerance.
For patients with diabetes mellitus, the insuline dose may require adjustment after somatropin containing product therapy is initiated. Patients with diabetes or glucose intolerance should be monitored closely during somatropin therapy.
ZOMACTON should also be used with caution in patients with a family history predisposing for the disease. Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. In patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked and glucocorticoid replacement may be required.
5). In patients with growth hormone deficiency secondary to an intra-cranial lesion, frequent monitoring for progression or recurrence of the underlying disease process is advised. In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.
Intracranial tumours, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, were the most common of these second neoplasms Discontinue ZOMACTON therapy if progression or recurrence of the lesion occurs.
In patients with previous malignant diseases special attention should be given to signs and symptoms of relapse. Scoliosis may progress in any child during rapid growth. Signs of scoliosis should be monitored during somatropin treatment.
Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders. A patient treated with ZOMACTON who develops a limp or complains of hip or knee pain should be evaluated by a physician. The effects of treatment with growth hormone on recovery were studied in two placebo controlled trials involving 522 critically ill adult patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure.
Mortality was higher (42 % vs. 3 to 8 mg/day) compared to those receiving placebo. Based on this information, such patients should not be treated with growth hormones. As there is no information available on the safety of growth hormone substitution therapy in acutely critically ill patients, the benefits of continued treatment in this situation should be weighed against the potential risks involved.
Pancreatitis Although rare, pancreatitis should be considered in somatropin-treated patients who develop abdominal pain, especially in children. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.