VAXZEVRIA Suspension for injection (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Vaxzevria suspension for injection. COVID-19 Vaccine (ChAdOx1-S [recombinant]).
2. Qualitative and quantitative composition
These are multidose vials which contain 8 doses or 10 doses of 0.5 ml per vial (see section 6.5). <u>One dose (0.5 ml) contains:</u> Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)*, ...
3. Pharmaceutical form
Suspension for injection (injection). The suspension is colourless to slightly brown, clear to slightly opaque with a pH of 6.6.
4.1. Therapeutic indications
Vaxzevria is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations. ...
4.2. Posology and method of administration
Posology Individuals 18 years of age and older The Vaxzevria primary vaccination course consists of two separate doses of 0.5 ml each. The second dose should be administered between 4 and 12 weeks (28 ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria ...
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. Hypersensitivity and anaphylaxis ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Concomitant administration of Vaxzevria with other vaccines has not been studied.
4.6. Fertility, pregnancy and lactation
Pregnancy There is limited experience with use of Vaxzevria in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition ...
4.7. Effects on ability to drive and use machines
Vaxzevria has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability to drive or use ...
4.8. Undesirable effects
Summary of the safety profile Primary vaccination course The overall safety of Vaxzevria is based on an analysis of pooled data from four clinical studies phase I/II, II/III and III conducted in the United ...
4.9. Overdose
There is no specific treatment for an overdose with Vaxzevria. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vaccines, other viral vaccines <b>ATC code:</b> J07BX03 Mechanism of action Vaxzevria is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
In a repeat-dose toxicity study in mice, IM administration of Vaxzevria was well tolerated. Nonadverse, mixed and/or mononuclear cell inflammation was observed in the subcutaneous tissues and skeletal ...
6.1. List of excipients
L-Histidine L-Histidine hydrochloride monohydrate Magnesium chloride hexahydrate Polysorbate 80 (E433) Ethanol Sucrose Sodium chloride Disodium edetate (dihydrate) Water for injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products or diluted.
6.3. Shelf life
Unopened vial 9 months when stored in a refrigerator (2°C–8°C). The following information is intended to guide healthcare professionals only in case of an unforeseen temporary temperature excursion. It ...
6.4. Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Keep vials in outer carton in order to protect from light. For storage conditions after first opening of the medicinal product, see section 6.3.
6.5. Nature and contents of container
Multidose vial <u>8-dose vial:</u> 4 mL of suspension in an 8-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 8 doses of 0.5 mL. Pack sizes of 10 multidose ...
6.6. Special precautions for disposal and other handling
Handling instructions and administration This vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose. Do not use this vaccine after the expiry ...
7. Marketing authorization holder
AstraZeneca AB, SE-151 85 Södertälje, Sweden
8. Marketing authorization number(s)
EU/1/21/1529/001 10 multidose vials (8 doses per vial) EU/1/21/1529/002 10 multidose vials (10 doses per vial)
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29 January 2021 Date of latest renewal: 9 November 2021
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