GARDASIL 9 Suspension for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
Gardasil 9 suspension for injection. Gardasil 9 suspension for injection in a pre-filled syringe. Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed).
2. Qualitative and quantitative composition
1 dose (0.5 ml) contains approximately: Human Papillomavirus<sup>1</sup> Type 6 L1 protein<sup>2,3</sup>: 30 micrograms Human Papillomavirus<sup>1</sup> Type 11 L1 protein<sup>2,3</sup>: 40 micrograms ...
3. Pharmaceutical form
Suspension for injection. Clear liquid with white precipitate.
4.1. Therapeutic indications
Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases: Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus ...
4.2. Posology and method of administration
Posology Individuals 9 to and including 14 years of age at time of first injection Gardasil 9 can be administered according to a 2-dose (0,6-12 months) schedule (see section 5.1). The second dose should ...
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Individuals with hypersensitivity after previous administration of Gardasil 9 or Gardasil/Silgard should not ...
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. The decision to vaccinate an individual ...
4.5. Interaction with other medicinal products and other forms of interaction
Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials. Use with other vaccines ...
4.6. Fertility, pregnancy and lactation
Pregnancy A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicates no malformative nor foeto/neonatal toxicity of Gardasil 9 (see section 5.1). Animal studies do not indicate ...
4.7. Effects on ability to drive and use machines
Gardasil 9 has no or negligible influence on the ability to drive or use machines. However, some of the effects mentioned under section 4.8 Undesirable effects may temporarily affect the ability to drive ...
4.8. Undesirable effects
A. Summary of the safety profile In 7 clinical trials, individuals were administered Gardasil 9 on the day of enrolment and approximately 2 and 6 months thereafter. Safety was evaluated using vaccination ...
4.9. Overdose
No cases of overdose have been reported.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vaccines, Papillomavirus vaccines <b>ATC code:</b> J07BM03 Mechanism of action Gardasil 9 is an adjuvanted non-infectious recombinant 9-valent vaccine. It is prepared ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
A repeat dose toxicity study in rats, which included an evaluation of single-dose toxicity and local tolerance, revealed no special hazards to humans. Gardasil 9 administered to female rats had no effects ...
6.1. List of excipients
Sodium chloride Histidine Polysorbate 80 Borax Water for injections For adjuvant, see section 2.
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Gardasil 9 suspension for injection Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. Gardasil 9 should be administered as soon as possible ...
6.5. Nature and contents of container
Gardasil 9 suspension for injection 0.5 ml suspension in a vial (glass) with stopper (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1. Gardasil 9 suspension for injection ...
6.6. Special precautions for disposal and other handling
<u>Gardasil 9 suspension for injection:</u> Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation. Shake well before use to make a suspension. After thorough agitation, it ...
7. Marketing authorization holder
MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
8. Marketing authorization number(s)
EU/1/15/1007/001 EU/1/15/1007/002 EU/1/15/1007/003 EU/1/15/1007/004
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 10 June 2015 Date of latest renewal: 16 January 2020
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