NUCALA Powder for solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Nucala 100 mg powder for solution for injection.
Qualitative and quantitative composition
Each vial contains 100 mg mepolizumab. After reconstitution, each ml of solution contains 100 mg mepolizumab. Mepolizumab is a humanised monoclonal antibody produced in Chinese hamster ovary cells by recombinant ...
Pharmaceutical form
Powder for solution for injection. Lyophilised white powder.
Therapeutic indications
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older (see section 5.1).
Posology and method of administration
Nucala should be prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma. Posology Adults and adolescents aged 12 years and older The recommended dose ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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 product should be clearly recorded in the patient file. Asthma exacerabations ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab. Increased levels of pro-inflammatory cytokines ...
Pregnancy and lactation
Pregnancy There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women. Mepolizumab crosses the placental barrier in monkeys. Animal studies do not ...
Effects on ability to drive and use machines
Nucala has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Adults and adolescents In clinical studies in subjects with severe refractory eosinophilic asthma, the most commonly reported adverse reactions during treatment were headache, ...
Overdose
Single doses of up to 1,500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities. There is no specific treatment for ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases ATC code: R03DX09 Mechanism of action Mepolizumab is a humanised monoclonal antibody ...
Pharmacokinetic properties
Following subcutaneous dosing in patients with asthma, mepolizumab exhibited approximately dose-proportional pharmacokinetics over a dose range of 12.5 mg to 250 mg. Absorption Following subcutaneous administration ...
Preclinical safety data
As mepolizumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been conducted. Animal toxicology and/or pharmacology Non-clinical data reveal no special hazards for humans based ...
List of excipients
Sucrose Sodium phosphate dibasic heptahydrate Polysorbate 80
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 4 years. After reconstitution: Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30°C. From a microbiological point ...
Special precautions for storage
Store below 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Clear, colourless 10 mL type I glass vial, with bromobutyl rubber stopper and a grey aluminium overseal with a plastic flip-cap containing 100 mg powder for solution for injection. Pack sizes: 1 vial ...
Special precautions for disposal and other handling
Reconstitution should be carried out under aseptic conditions. Instructions for reconstitution for each vial: Reconstitute the contents of the vial with 1.2 mL of sterile water for injections preferably ...
Marketing authorization holder
GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland
Marketing authorization number(s)
EU/1/15/1043/001 EU/1/15/1043/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 02 December 2015
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