SYNAGIS Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Synagis 50 mg/0.5 ml solution for injection. Synagis 100 mg/1 ml solution for injection.
Qualitative and quantitative composition
1 ml of Synagis solution contains 100 mg of palivizumab*. Each 0.5 ml vial contains 50 mg of palivizumab. Each 1 ml vial contains 100 mg of palivizumab. * Palivizumab is a recombinant humanised monoclonal ...
Pharmaceutical form
Solution for injection. The solution is clear or slightly opalescent.
Therapeutic indications
Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: Children ...
Posology and method of administration
Posology The recommended dose of palivizumab is 15 mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community. The volume (expressed in ml) of Palivizumab to be administered ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.
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. Allergic reactions including very ...
Interaction with other medicinal products and other forms of interaction
No formal interactions studies with other medicinal products were conducted. In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric populations, the proportions of ...
Pregnancy and lactation
Not relevant. Synagis is not indicated for use in adults. Data on fertility, pregnancy and lactation are not available.
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions. Common adverse reactions occurring with palivizumab ...
Overdose
In clinical studies, three children received an overdose of more than 15 mg/kg. These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg. No medical consequences were identified in these instances. From ...
Pharmacodynamic properties
Pharmacotherapeutic group: immune sera immunoglobulins, specific immunoglobulins ATC Code: J06BB16 Palivizumab is a humanised IgG<sub>1κ</sub> monoclonal antibody directed to an epitope in the A antigenic ...
Pharmacokinetic properties
Lyophilised formulation of palivizumab In studies in adult volunteers, palivizumab had a pharmacokinetic profile similar to a human IgG1 antibody with regard to volume of distribution (mean 57 ml/kg) and ...
Preclinical safety data
Single dose toxicology studies have been conducted in cynomolgus monkeys (maximum dose 30 mg/kg), rabbits (maximum dose 50 mg/kg) and rats (maximum dose 840 mg/kg). No significant findings were observed. ...
List of excipients
Histidine Glycine Water for injections
Incompatibilities
This medicinal product should not be mixed with other medicinal products.
Shelf life
Shelf-life: 3 years.
Special precautions for storage
Store in a refrigerator (2ºC to 8ºC). Do not freeze. Keep the vial in the carton in order to protect from light.
Nature and contents of container
Single-use vials: 3 ml capacity, clear, colourless type I glass vial with a chlorobutyl stopper and flipoff seal containing either 0.5 ml or 1 ml of solution for injection. Pack size of 1.
Special precautions for disposal and other handling
Do not mix the palivizumab liquid and lyophilised formulations. Do not dilute the product. Do not shake the vial. Both the 0.5 ml and 1 ml vials contain an overfill to allow the withdrawal of 50 mg or ...
Marketing authorization holder
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061, Ludwigshafen, Germany
Marketing authorization number(s)
EU/1/99/117/003 EU/1/99/117/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
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