![]() The risk of myocarditis after a third dose of Comirnaty has not yet been characterised.Īnxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. They have been observed more often after the second vaccination, and more often in younger males (see section 4.8). These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.Ĭlose observation for at least 15 minutes is recommended following vaccination. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.Įvents of anaphylaxis have been reported. The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.įor precautions to be taken before administering the vaccine, see section 4.4.įor instructions regarding thawing, handling and disposal of the vaccine, see section 6.6. The preferred site is the deltoid muscle of the upper arm. Do not pool excess vaccine from multiple vials.If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.Each dose must contain 0.2 mL of vaccine.Irrespective of the type of syringe and needle: If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. In order to extract 10 doses from a single vial, low dead-volume syringes and/or needles should be used. The safety and efficacy of Comirnaty in children aged less than 5 years have not yet been established.Ĭomirnaty 10 micrograms/dose concentrate for dispersion for injection should be administered intramuscularly after dilution (see section 6.6).Īfter dilution, vials of Comirnaty contain 10 doses of 0.2 mL of vaccine. ![]() Individuals who have received a dose of Comirnaty should continue to receive Comirnaty to complete the primary course.Ĭomirnaty 10 micrograms/dose should be used only for children 5 to 11 years of age. The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary course has not been established. Severely immunocompromised aged 5 years and olderĪ third primary course dose may be administered intramuscularly at least 28 days after the second dose to individuals who are severely immunocompromised (see section 4.4). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1). Date of first authorisation/renewal of the authorisationĬhildren 5 to 11 years of age (i.e., 5 to less than 12 years of age)Ĭomirnaty 10 micrograms/dose is administered intramuscularly after dilution as a primary course of 2 doses (0.2 mL each). 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction. ![]() 4.4 Special warnings and precautions for use. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |