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Factsheet Of Gam-COVID-Vac Combined Vector Vaccine (Component I & II) SPUTNIK V Of Dr. Reddy's Laboratories Ltd


Gam- COVID Vac combines vector Vaccine SPUTNIK V of Dr.Reddys Laboratories is being offered for preventing coronavirus disease 2019 caused by SARS-Cov-2. The fact sheet is given here assists you in understanding all the risks and the benefits of the vaccine.

This vaccination is carried out in two stages. The first stage is with component 1, then after three weeks with component 11. The product is given intramuscularly. The first dose of 0.5ml is given, and then after three weeks, an amount of 0.5ml is given. After administering the vaccine, the patient must be monitored by a competent healthcare professional for about 30 minutes.

There are certain things you need to know before you get this vaccine shot.

The vaccine has got permission for getting used in an emergency situation. It has not obtained the marketing authorization, but its approval for restricted use grants permission for getting used for active immunizations of those individuals who are above 18 years for preventing COVID-19 disease. Like any new medicine, this vaccine will be monitored to allow rapid identification of some further safety information. You can assist by reporting any side effects you might get after vaccination to Dr-Reddy laboratories. Every adverse effect should be entered in COWIN App by a health care provider. This is all according to the regulatoryprocess for import of drugs in India.

Before you use Sputnik V

  • Tell your healthcare provider about all of your medical conditions, which includes
  • Kidney and liver problems.
  • Problems with your endocrine system
  • The disease of the hematopoietic system
  •  Problems in association with your cardiovascular system
  • Lung diseases like asthma or COPD
  • If you are pregnant or plan to become pregnant

Who should get Sputnik Vaccine?

Sputnik vaccine has got approval for emergency use in individuals over 18 years.

One should not get the vaccine when they have

  • Allergy to any of the components of the vaccine
  • History of any severe allergic reaction.
  • If you are suffering from cold, fever, cough, body ache, or loose motions.

Ingredients of sputnik vaccine

Component 1 contains Active substance: recombinant adenovirus serotype 26 particles that contain SARS COV 2 protein S gene 1.0 +-0.5 * 1011  particles.

Excipients: Tris-aminomethane - 1.21 mg, sodium chloride - 2.19 mg, sucrose -25.0 mg, magnesium chloride hexahydrate -102.0 μg, EDTA disodium salt dehydrate - 19.0 μg, polysorbate 80 - 250.0 μg, ethanol 95% - 2.50 μl, water for injection Q.s to 0.5 ml.

Component II – Active ingredients: Recombinant adenovirus serotype 5 particles containing the SARS Cov- 2 protein s gene 1.0±0.5 x 1011  Particles. Excipients: Tris aminomethane -1.21 mg, sodium chloride - 2.19 mg, sucrose -25.0 mg, magnesium chloride hexahydrate -102.0 μg, EDTA disodium salt dehydrate - 19.0 μg, polysorbate 80 - 250.0 μg, ethanol 95% - 2.50 μl, water for injection Q.s to 0.5 ml.

How is sputnik given?

The sputnik vaccine is given as an intramuscular injection primarily in the deltoid muscle. While the first dose is given, the second dose is given after three weeks. If, by any chance, you miss getting your shot, then ask your healthcare provider about it.

Significant benefits of Sputnik V vaccine.

Sputnik V vaccine helps in preventing Covid 19 disease after three weeks of the second dose. The duration up to which the vaccine offers protection is still under study. You might get a protective response 1-3 weeks after the double dose. Therefore, it is necessary to practice all precautions for preventing SARS COV -2 infection until three weeks after the second dose.

What are the different risks involved with the Sputnik vaccine?

Some of the side effects of the Sputnik vaccine are tenderness, pain, swelling, bruising, itching, muscle pain, runny nose, cough, stomach ache, feeling feverish, sore throat, decrease appetite.

Sputnik V vaccine is still under study in clinical trials, and follow-up trials are still going on.

#Regulatoryprocessorimportandexportofdrugsinindia



This post first appeared on Amendments Made In Medical Device Rules For NABL Accreditation, please read the originial post: here

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Factsheet Of Gam-COVID-Vac Combined Vector Vaccine (Component I & II) SPUTNIK V Of Dr. Reddy's Laboratories Ltd

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