INCRELEX Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
INCRELEX 10 mg/ml solution for injection.
Qualitative and quantitative composition
Each ml contains 10 mg of mecasermin*. Each vial of 4 ml contains 40 mg of mecasermin*. * Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli. ...
Pharmaceutical form
Solution for injection (injection). Aqueous, clear and colourless solution.
Therapeutic indications
For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with confirmed severe primary insulin-like growth factor-1 deficiency (Primary IGFD). Severe Primary IGFD is ...
Posology and method of administration
Treatment with mecasermin should be directed by physicians who are experienced in the diagnosis and management of patients with growth disorders. Posology The dose should be individualised for each patient. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. INCRELEX is contraindicated in children and adolescents with active or suspected neoplasia, or any condition ...
Special warnings and precautions for use
Benign and malignant neoplasms There is an increased risk of benign and malignant neoplasia in children and adolescents treated with INCRELEX, since IGF-1 plays a role in the initiation and progression ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced (see section 4.4).
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females A negative pregnancy test is recommended for all women of child bearing potential prior to treatment with mecasermin. It is also recommended ...
Effects on ability to drive and use machines
INCRELEX may have a major influence on the ability to drive or use machines in case of a hypoglycaemic episode. Hypoglycaemia is a very common adverse reaction.
Undesirable effects
Summary of the safety profile Adverse reaction data was taken from a total of 413 clinical trial patients with severe Primary IGFD. Data was also collected from post-marketing sources. The most frequently ...
Overdose
Acute overdose could lead to hypoglycaemia. Treatment of acute overdose of mecasermin should be directed at alleviating any hypoglycaemic effects. Oral glucose or food should be consumed. If the overdose ...
Pharmacodynamic properties
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and somatropin agonists ATC code: H01AC03 Mecasermin is a human insulin-like growth factor-1 (rhIGF-1) produced ...
Pharmacokinetic properties
Absorption The absolute subcutaneous bioavailability of mecasermin in severe Primary IGFD subjects has not been determined. The bioavailability of mecasermin after subcutaneous administration in healthy ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity. Adverse reactions not observed in clinical studies, but ...
List of excipients
Benzyl alcohol Sodium chloride Polysorbate 20 Glacial acetic acid Sodium acetate Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. After opening: Chemical and physical in-use stability has been demonstrated for 30 days at 2°C to 8°C. From a microbiological point of view, once opened, the medicinal product may ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3. ...
Nature and contents of container
5 ml vial (type I glass) closed with a stopper (bromobutyl/isoprene polymer) and a seal (lacquered plastic). Each vial contains 4 ml of solution. Pack size of 1 vial.
Special precautions for disposal and other handling
INCRELEX is supplied as a multi-dose solution. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Ipsen Pharma, 65, quai Georges Gorse, 92100, Boulogne-Billancourt, France
Marketing authorization number(s)
EU/1/07/402/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 03 August 2007 Date of latest renewal: 03 August 2017
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