VAQTA ADULT Suspension for injection (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
VAQTA Adult, suspension for injection. Hepatitis A vaccine, inactivated, adsorbed. For adults.
Qualitative and quantitative composition
One dose (1mL) contains: Hepatitis A virus (strain CR 326F) (inactivated)<sup>1,2</sup>: 50 U<sup>3</sup>. 1 Produced on human diploid (MRC–5) fibroblast cells. 2 Adsorbed on amorphous aluminium hydroxyphosphate ...
Pharmaceutical form
Suspension for injection in a prefilled syringe or vial.
Therapeutic indications
VAQTA Adult is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. VAQTA Adult is recommended for healthy adults 18 years of age and older who are at risk of contracting ...
Posology and method of administration
Posology The vaccination series consists of one primary dose and one booster dose given according to the following schedule: <u>Primary dose:</u> Adults 18 years of age and older should receive a single ...
Contraindications
History of hypersensitivity to the active substances, to any of the excipients listed in section 6.1, to neomycin or to formaldehyde (which may be present as trace residues, see sections 2 and 4.4). Vaccination ...
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. Individuals who develop symptoms ...
Interaction with other medicinal products and other forms of interaction
If VAQTA Adult is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained. Known or presumed ...
Fertility, pregnancy and lactation
Pregnancy It is not known whether VAQTA Adult can cause foetal harm when administered to a pregnant woman, or can affect reproduction capacity. VAQTA Adult is not recommended in pregnancy unless there ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, VAQTA Adult is expected to have no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile In clinical trials with 1,529 healthy adults who received one or more doses of hepatitis A vaccine, subjects were followed for elevated temperature and local reactions during ...
Overdose
There are no data with regard to overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: viral vaccines, hepatitis A, inactivated, whole virus ATC code: J07BC02 VAQTA Adult contains inactivated virus of a strain which was originally derived by further serial passage ...
Pharmacokinetic properties
Evaluation of pharmacokinetic properties is not required for vaccines.
Preclinical safety data
No preclinical safety testing was performed using the vaccine.
List of excipients
Sodium borate Sodium chloride Water for injections For adjuvant and for information regarding residual components in trace quantities, see sections 2, 4.3 and 4.4.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
3 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). DO NOT FREEZE since freezing destroys potency.
Nature and contents of container
1 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend). 1 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene ...
Special precautions for disposal and other handling
The vaccine should be used as supplied; no reconstitution is necessary. Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration. ...
Marketing authorization holder
Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
Marketing authorization number(s)
PL 53095/0007
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 August 1996 Date of latest renewal: 16 October 2006
Date of revision of the text
29 January 2021
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
