ROTARIX Powder and solvent for oral suspension (2022)
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Περιεχόμενα
Name of the medicinal product
Rotarix powder and solvent for oral suspension. Rotavirus vaccine, live.
Qualitative and quantitative composition
<u>After reconstitution, 1 dose (1 ml) contains:</u> Human rotavirus RIX4414 strain (live, attenuated)* not less than 10<sup>6.0</sup> CCID<sub>50</sub>. * Produced on Vero cells Excipients with known ...
Pharmaceutical form
Powder and solvent for oral suspension. The powder is white. The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.
Therapeutic indications
Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). The use of Rotarix should be ...
Posology and method of administration
Posology The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity after previous administration of rotavirus vaccines. History of intussusception. Subjects with ...
Special warnings and precautions for use
It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination. There are no data on the ...
Interaction with other medicinal products and other forms of interaction
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), ...
Pregnancy and lactation
Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and lactation. Based on evidence generated in clinical trials, breast-feeding does not reduce the protection ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix. In a total of four clinical ...
Overdose
Some cases of overdose have been reported. In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix.
Pharmacodynamic properties
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines ATC code: J07BH01 Protective efficacy In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common ...
Pharmacokinetic properties
Not applicable.
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
List of excipients
Powder: Sucrose Dextran Sorbitol Amino acids Dulbeccos Modified Eagle Medium (DMEM) Solvent: Calcium carbonate Xanthan gum Sterile water
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years. <u>After reconstitution:</u> After the reconstitution, the vaccine should be administered immediately. If not used immediately, in-use storage should not be longer than 24 hours and at a temperature ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Store in the original package, in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3. ...
Nature and contents of container
1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl). 1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl). ...
Special precautions for disposal and other handling
Before reconstitution A white deposit and clear supernatant is observed upon storage of the oral applicator containing the solvent. The solvent should be inspected visually for any foreign particulate ...
Marketing authorization holder
GlaxoSmithKline Biologicals s.a., Rue de lInstitut 89, B-1330, Rixensart, Belgium
Marketing authorization number(s)
EU/1/05/330/001 EU/1/05/330/002 EU/1/05/330/003 EU/1/05/330/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 February 2006 Date of latest renewal: 14 January 2016
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