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SPIKEVAX Dispersion for injection (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Spikevax dispersion for injection. COVID-19 mRNA Vaccine (nucleoside modified).

2. Qualitative and quantitative composition

This is a multidose vial which contains 10 doses of 0.5 mL. One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles). One dose (0.25 mL) contains 50 micrograms ...

3. Pharmaceutical form

Dispersion for injection. White to off white dispersion (pH: 7.0–8.0).

4.1. Therapeutic indications

Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 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 Primary series Individuals 12 years of age and older Spikevax is administered as a course of 2 (two) 100 microgram doses (0.5 mL each). It is recommended to administer the second dose 28 days ...

4.3. Contraindications

Hypersensitivity to the active substance 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. Hypersensitivity and anaphylaxis ...

4.5. Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. Concomitant administration of Spikevax with other vaccines has not been studied.

4.6. Fertility, pregnancy and lactation

Pregnancy There is limited experience with use of Spikevax 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

Spikevax has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. ...

4.8. Undesirable effects

Summary of the safety profile Participants 18 years of age and older The safety of Spikevax was evaluated in an ongoing Phase 3 randomised, placebo-controlled, observer-blind clinical study conducted in ...

4.9. Overdose

No case of overdose has been reported. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Vaccine, other viral vaccines <b>ATC code:</b> J07BX03 Mechanism of action Spikevax contains mRNA encapsulated in lipid nanoparticles. The mRNA encodes for the full-length ...

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 repeat dose toxicity and reproductive and developmental toxicity. General toxicity General toxicity studies were conducted ...

6.1. List of excipients

Lipid SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate) Cholesterol 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene ...

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products or diluted.

6.3. Shelf life

Unopened vial 7 months at -25ºC to -15ºC. The unopened vaccine may be stored refrigerated at 2°C to 8°C, protected from light, for maximum 30 days. Within this period, up to 12 hours may be used for transportation. ...

6.4. Special precautions for storage

Store frozen between -25ºC to -15ºC. Store in the original carton to protect from light. Do not store on dry ice or below -50ºC. For storage conditions after thawing and first opening see section 6.3. ...

6.5. Nature and contents of container

5 mL dispersion in a vial (type 1 or type 1 equivalent glass) with a stopper (chlorobutyl rubber) and a flip-off plastic cap with seal (aluminium seal). Each vial contains 5 mL. <u>Pack size:</u> 10 multidose ...

6.6. Special precautions for disposal and other handling

The vaccine should be prepared and administered by a trained healthcare professional using aseptic techniques to ensure sterility of the dispersion. The vaccine comes ready to use once thawed. Do not shake ...

7. Marketing authorization holder

MODERNA BIOTECH SPAIN, S.L., Calle Monte Esquinza 30, 28010 Madrid, Spain

8. Marketing authorization number(s)

EU/1/20/1507/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 06 January 2021 Date of latest renewal: 04 October 2021

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