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SPC, UK: GENOTROPIN Powder and solvent for solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

GENOTROPIN 5.3 mg, powder and solvent for solution for injection.

Qualitative and quantitative composition

GENOTROPIN 5.3 mg powder and solvent for solution for injection, with preservative. One cartridge contains 5.3 mg somatropin*. After reconstitution the concentration of somatropin is 5.3 mg/ml. * produced ...

Pharmaceutical form

Powder and solvent for solution for injection. In the two-chamber cartridge there is a white powder in the front compartment and a clear solution in the rear compartment.

Therapeutic indications

Children Growth disturbance due to insufficient secretion of growth hormone (growth hormone deficiency, GHD) and growth disturbance associated with Turner syndrome or chronic renal insufficiency. Growth ...

Posology and method of administration

The dosage and administration schedule should be individualized. The injection should be given subcutaneously and the site varied to prevent lipoatrophy. Growth disturbance due to insufficient secretion ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial tumours must be inactive and antitumour ...

Special warnings and precautions for use

Diagnosis and therapy with GENOTROPIN should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication ...

Interaction with other medicinal products and other forms of interaction

Concomitant treatment with glucocorticoids inhibits the growth-promoting effects of somatropin containing products. Patients with Adrenocorticotropic hormone (ACTH) deficiency should have their glucocorticoid ...

Pregnancy and lactation

Pregnancy Animal studies are insufficient with regard to effects on pregnancy, embryofoetal development, parturition or postnatal development (See section 5.3). No clinical studies on exposed pregnancies ...

Effects on ability to drive and use machines

GENOTROPIN has no influence on the ability to drive and use machines.

Undesirable effects

Patients with growth hormone deficiency are characterized by extracellular volume deficit. When treatment with somatropin is started this deficit is rapidly corrected. In adult patients adverse effects ...

Overdose

Symptoms Acute overdosage could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term overdosage could result in signs and symptoms consistent with the known effects of human growth ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anterior pituitary lobe hormones and analogues ATC code: H01AC01 Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. ...

Pharmacokinetic properties

Absorption The bioavailability of subcutaneously administered somatropin is approximately 80 % in both healthy subjects and growth hormone deficient patients. A subcutaneous dose of 0.035 mg/kg of somatropin ...

Preclinical safety data

In studies regarding general toxicity, local tolerance and reproduction toxicity no clinically relevant effects have been observed. In vitro and in vivo genotoxicity studies on gene mutations and induction ...

List of excipients

Powder: Front compartment Glycine (E640) Sodium dihydrogen phosphate anhydrous (E339) Disodium phosphate anhydrous (E339) Mannitol (E421) Solvent: Rear compartment Water for injections Metacresol Mannitol ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years. Chemical and physical in-use stability has been demonstrated for 4 weeks at 2°C-8°C. From a microbiological point of view, once reconstituted, the product may be stored for 4 weeks ...

Special precautions for storage

Before reconstitution: Store in a refrigerator (2°C–8°C), or for a maximum of 1 month at or below 25°C. Keep the two-chamber cartridge/pre-filled pen in the outer carton in order to protect from light. ...

Nature and contents of container

Powder and 1 ml solvent in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap ...

Special precautions for disposal and other handling

Only reconstitute the powder with the solvent supplied. Two-chamber cartridge: The solution is prepared by screwing the reconstitution device or injection device or GoQuick pre-filled pen sections together ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/0987

Date of first authorization / renewal of the authorization

1 February 1995/21 April 2010

Date of revision of the text

06/2018

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