KANUMA Concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
KANUMA 2 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each ml of concentrate contains 2 mg sebelipase alfa*. Each vial of 10 ml contains 20 mg sebelipase alfa. * produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology. Excipient with ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to slightly coloured solution.
Therapeutic indications
KANUMA is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase (LAL) deficiency.
Posology and method of administration
KANUMA treatment should be supervised by a healthcare professional experienced in the management of patients with LAL deficiency, other metabolic disorders, or chronic liver diseases. KANUMA should be ...
Contraindications
Life-threatening hypersensitivity (anaphylactic reaction) to the active substance when attempts to rechallenge are unsuccessful, or to egg or any of the excipients listed in section 6.1, (see section 4.4). ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Hypersensitivity reactions ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Because it is a recombinant human protein, sebelipase alfa is an unlikely candidate for cytochrome P450 mediated or other drug-drug interactions.
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of sebelipase alfa in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). ...
Effects on ability to drive and use machines
KANUMA has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of safety profile The most serious adverse reactions experienced by 3% of patients in clinical studies were signs and symptoms consistent with anaphylaxis. Signs and symptoms included chest discomfort, ...
Overdose
In clinical studies, doses of sebelipase alfa were explored up to 5 mg/kg once weekly and no specific signs or symptoms were identified following the higher doses. For management of adverse reactions, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes ATC code: A16AB14 Lysosomal acid lipase (LAL) deficiency LAL deficiency is a rare disease associated with significant ...
Pharmacokinetic properties
Children and adults The pharmacokinetics of sebelipase alfa in children and adults were determined using a population pharmacokinetic analysis of 65 patients with LAL deficiency who received intravenous ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity in rats and monkeys, or fertility, embryo-foetal and peri- and postnatal ...
List of excipients
Sodium citrate Citric acid monohydrate Human serum albumin Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
<u>Unopened vials:</u> 2 years. <u>After dilution:</u> Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C, or up to 12 hours below 25°C. From a microbiological ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original package in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Clear glass vial (Type I) with a siliconised butyl rubber stopper, and an aluminium seal with a plastic flipoff cap, containing 10 ml of concentrate. Pack size: 1 vial.
Special precautions for disposal and other handling
Each vial of KANUMA is intended for single use only. KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. The diluted solution should be administered ...
Marketing authorization holder
Alexion Europe SAS, 103-105 rue Anatole France, 92300, Levallois-Perret, France
Marketing authorization number(s)
EU/1/15/1033/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 August 2015
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