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CEREZYME Powder for concentrate for solution for infusion (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cerezyme 400 Units Powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains 400 units* of imiglucerase**. After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml). * An enzyme unit (U) is defined as the ...

Pharmaceutical form

Powder for concentrate for solution for infusion. Cerezyme is a white to off-white powder.

Therapeutic indications

Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease ...

Posology and method of administration

Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease. Posology Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should ...

Contraindications

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

Special warnings and precautions for use

Hypersensitivity Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Pregnancy and lactation

Pregnancy Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial to control the underlying ...

Effects on ability to drive and use machines

Cerezyme has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Tabulated list of adverse reactions Adverse reactions are listed by system organ class and frequency (common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)) in the table ...

Overdose

No case of overdose has been reported. In patients dosages up to 240 U/kg body weight once every two weeks have been used.

Pharmacodynamic properties

Pharmacotherapeutic group: Enzymes-Imiglucerase (recombinant macrophage targeted β-glucocerebrosidase) ATC code: A16AB02 Mechanism of action Gaucher disease is a rare recessively inherited metabolic disorder ...

Pharmacokinetic properties

During 1 hour intravenous infusions of 4 doses (7.5, 15, 30, 60 U/kg) of imiglucerase, steady-state enzymatic activity was achieved by 30 minutes. Following infusion, plasma enzymatic activity declined ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.

List of excipients

Mannitol Sodium citrate (to adjust pH) Citric acid monohydrate (to adjust pH) Polysorbate 80

Incompatibilities

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

Shelf life

Shelf life Unopened vials: 3 years. Diluted solution: From a microbiological safety point of view, the product should be used immediately. If not used immediately, in-use storage and conditions prior to ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). For storage conditions after dilution of the medicinal product, see section 6.3.

Nature and contents of container

Cerezyme is supplied in type I borosilicate (clear) glass 20 ml vials. The closure consists of a siliconised butyl stopper with a tamper proof flip-off cap. To provide sufficient volume to allow accurate ...

Special precautions for disposal and other handling

Each vial of Cerezyme is for single use only. The powder for concentrate for solution for infusion has to be reconstituted with water for injections, diluted with 0.9% sodium chloride intravenous solution ...

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, the Netherlands

Marketing authorization number(s)

EU/1/97/053/003 Cerezyme 400 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 Cerezyme 400 Units 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 November 1997 Date of latest renewal: 17 September 2007

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