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NORMOSANG Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

NORMOSANG 25 mg/ml, concentrate for solution for infusion.

Qualitative and quantitative composition

Human hemin 25 mg/ml. One ampoule of 10 ml contains 250 mg of human hemin. After dilution of one 10 ml ampoule in 100 ml of 0.9% Na Cl solution, the diluted solution contains 2273 micrograms per ml of ...

Pharmaceutical form

Concentrate for solution for infusion. NORMOSANG is a dark coloured concentrate for solution for infusion.

Therapeutic indications

Treatment of acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegata, hereditary coproporphyria).

Posology and method of administration

Posology The recommended daily dose is 3 mg/kg once daily for four days, diluted in 100 ml of 0.9% sodium chloride in a glass bottle and infused intravenously over at least 30 minutes into a large antebrachial ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Before treatment is started, it is necessary to confirm an attack of hepatic porphyria by series of clinical and biological criteria: suggestive family or personal history, suggestive clinical signs, ...

Interaction with other medicinal products and other forms of interaction

During treatment with NORMOSANG the enzyme activity of the P450 enzymes increases. The metabolism of concomitantly administered drugs that are metabolised by cytochrome P450 enzymes (such as oestrogens, ...

Pregnancy and lactation

Pregnancy In the absence of specific experimental and clinical data, the risks during pregnancy are not defined; to date, however, no after-effects have been observed in new-born babies whose mothers were ...

Effects on ability to drive and use machines

There is no evidence to suggest that NORMOSANG affects adversely the ability to drive or use machines.

Undesirable effects

The most commonly reported ADRs are infusion site reactions especially occurring if infusion takes place into veins which are too small (see section 4.4. Special warnings and precautions for use). Reported ...

Overdose

In animal experiments with NORMOSANG the acute toxic effects after high dosage were directed to the liver. Ten times higher total doses than the recommended human posology also decreased blood pressure ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other hematological agents ATC code: BO6AB Haem arginate is indicated for hepatic porphyria (intermittent acute porphyria, porphyria variegata and hereditary coproporphyria). ...

Pharmacokinetic properties

After an intravenous infusion of hemin (3 mg/kg), the pharmacokinetic parameters (mean ± SD) observed in healthy volunteers and patients with porphyria are as follows: C<sub>(o)</sub> 60.0 ± 17 µg/ml ...

Preclinical safety data

Non-clinical data reveal no special effects for humans based on studies of safety pharmacology, single dose, repeated dose toxicity, mutagenicity, immunogenicity. Due to the human origin of NORMOSANG non-clinical ...

List of excipients

Arginine Ethanol 96% Propylene glycol Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life: 2 years. After dilution, the solution should be used within 1 hour.

Special precautions for storage

Store in a refrigerator (2°C–8°C). Keep the ampoule in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

10 ml of solution in ampoule (type I glass) - pack of 4.

Special precautions for disposal and other handling

Preparation of the solution NORMOSANG, presented in ampoules, should be diluted immediately prior to administration in 100 ml of 0.9% NaCl solution in a glass bottle; the amount of product required, calculated ...

Marketing authorization holder

Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92800, Puteaux, France

Marketing authorization number(s)

PL 15266/0008 (UK) PA 0928/001/001 (Ireland)

Date of first authorization / renewal of the authorization

Date of latest renewal: 5 May 2019

Date of revision of the text

12 December 2019

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