JCOVDEN Suspension for injection (2022)
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Περιεχόμενα
1. Name of the medicinal product
JCOVDEN suspension for injection. COVID-19 vaccine (Ad26.COV2-S [recombinant]).
2. Qualitative and quantitative composition
This is a multi-dose vial which contains 5 doses of 0.5 mL. One dose (0.5 mL) contains: Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein* (Ad26.COV2-S), not less than 8.92 log<sub>10</sub> ...
3. Pharmaceutical form
Suspension for injection (injection). Colourless to slightly yellow, clear to very opalescent suspension (pH 6-6.4).
4.1. Therapeutic indications
JCOVDEN 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 Primary vaccination JCOVDEN is administered as a single-dose of 0.5 mL by intramuscular injection only. Booster dose A booster dose (second dose) of 0.5 mL ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. A history of confirmed thrombosis with thrombocytopenia syndrome (TTS) following vaccination with any COVID-19 ...
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 JCOVDEN with other vaccines has not been studied.
4.6. Fertility, pregnancy and lactation
Pregnancy There is limited experience with the use of JCOVDEN in pregnant women. Animal studies with JCOVDEN do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal ...
4.7. Effects on ability to drive and use machines
JCOVDEN 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 machines. ...
4.8. Undesirable effects
Summary of safety profile Primary vaccination (primary analysis) The safety of JCOVDEN was evaluated in an ongoing phase 3 study (COV3001). A total of 21 895 adults aged 18 years and older received JCOVDEN. ...
4.9. Overdose
No case of overdose has been reported. In phase ½ studies where a higher dose (up to 2-fold) was administered JCOVDEN remained well-tolerated, however vaccinated individuals reported an increase in reactogenicity ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Vaccines, other viral vaccines <b>ATC code:</b> J07BX03 Mechanism of action JCOVDEN is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus ...
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Non-clinical data reveal no special hazards for humans based on conventional studies of repeat-dose toxicity and local tolerance, and reproductive and developmental toxicity. Genotoxicity and carcinogenicity ...
6.1. List of excipients
<u>10 vial pack:</u> 2-hydroxypropyl-β-cyclodextrin (HBCD) Citric acid monohydrate Ethanol Hydrochloric acid Polysorbate-80 Sodium chloride Sodium hydroxide Trisodium citrate 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 2 years when stored at -25°C to -15°C. Once removed from the freezer, the unopened vaccine may be stored refrigerated at 2°C to 8°C, protected from light, for a single period of up to 3 months, ...
6.4. Special precautions for storage
Store and transport frozen at -25°C to -15°C. The expiry date for storage at -25°C to -15°C is printed on the vial and outer carton after EXP. When stored frozen at -25°C to -15°C, the vaccine can be thawed ...
6.5. Nature and contents of container
A 2.5 mL suspension in a multi-dose vial (type I glass) with a rubber stopper (chlorobutyl with fluoropolymer coated surface), aluminium crimp and blue plastic cap. Each vial contains 5 doses of 0.5 mL. ...
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. The vaccine comes ready to use once thawed. ...
7. Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
8. Marketing authorization number(s)
EU/1/20/1525/001 EU/1/20/1525/002
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 11 March 2021 Date of latest renewal: 03 January 2022
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