SHINGRIX Powder for suspension for injection (2023)
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Περιεχόμενα
1. Name of the medicinal product
Shingrix powder and suspension for suspension for injection. Herpes zoster vaccine (recombinant, adjuvanted).
2. Qualitative and quantitative composition
After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus<sup>1</sup> glycoprotein E antigen<sup>2,3</sup> 50 micrograms. 1 Varicella Zoster Virus = VZV 2 adjuvanted with AS01<sub>B</sub> ...
3. Pharmaceutical form
Powder and suspension for suspension for injection. The powder is white. The suspension is an opalescent, colourless to pale brownish liquid.
4.1. Therapeutic indications
Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in: adults 50 years of age or older; adults 18 years of age or older at increased risk of HZ. The use of Shingrix ...
4.2. Posology and method of administration
Posology The primary vaccination schedule consists of two doses of 0.5 mL each: an initial dose followed by a second dose 2 months later. If flexibility in the vaccination schedule is necessary, the second ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
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 product should be clearly recorded. Prior to immunisation As with all ...
4.5. Interaction with other medicinal products and other forms of interaction
Shingrix can be given concomitantly with unadjuvanted inactivated seasonal influenza vaccine, 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13), reduced ...
4.6. Pregnancy and lactation
Pregnancy There are no data from the use of Shingrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition ...
4.7. Effects on ability to drive and use machines
Shingrix may have a minor influence on the ability to drive and use machines in the 2-3 days following vaccination. Fatigue and malaise may occur following administration (see section 4.8).
4.8. Undesirable effects
Summary of the safety profile In adults aged 50 years and above, the most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose; 3.8% severe/dose), myalgia (32.9% overall/dose; ...
4.9. Overdose
No case of overdose has been reported.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Varicella zoster vaccines <b>ATC code:</b> J07BK03 Mechanism of action By combining the VZV specific antigen (gE) with an adjuvant system (AS01B), Shingrix is designed ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of acute and repeated dose toxicity, local tolerance, cardiovascular/respiratory safety pharmacology and toxicity to ...
6.1. List of excipients
<u>Powder (gE antigen):</u> Sucrose Polysorbate 80 (E433) Sodium dihydrogen phosphate dihydrate (E339) Dipotassium phosphate (E340) <u>Suspension (AS01<sub>B</sub> Adjuvant System):</u> Dioleoyl phosphatidylcholine ...
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years. <u>After reconstitution:</u> Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. From a microbiological point of view, the vaccine should be used immediately. If ...
6.4. 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.
6.5. Nature and contents of container
Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber) Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber). Shingrix is available in a pack size of 1 vial of ...
6.6. Special precautions for disposal and other handling
Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant). The powder and the suspension must ...
7. Marketing authorization holder
GlaxoSmithKline Biologicals S.A., Rue de lInstitut 89, B-1330 Rixensart, Belgium
8. Marketing authorization number(s)
EU/1/18/1272/001 EU/1/18/1272/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 21 March 2018 Date of latest renewal: 05 December 2022
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