Cofepris issues alert on hepatitis B vaccine fraud

Federal Council for the Protection of Health Risks (Kaufipli) issued health alert after multiple cases detected Counterfeit Hepatitis B Vaccine.

The Ministry of Health (SSa) said in a statement that the counterfeit product is Provibac-B, which appears to be a 200 microgram (20 ml) injection suspension and does not have a health approval.

In light of these incidents, Cofepris also reminds health professionals and the general public about the falsification of this biological agent.

It is understood that the Counterfeit Products The batch number on the secondary packaging or outer packaging is 2526211014-1, and the batch number on the vial label is 2566220/410-2; similarly, the expiry date on the secondary packaging is October 6, 2023, while the label states that it must be in 2023 Use before November.

The committee argued that falsification of the vaccine may represent health risks Due to unknown manufacturing, handling and storage conditions, its safety, quality and effectiveness cannot be guaranteed.

Characteristics of counterfeit batches. (X/@Cofepris)

Given this situation, Cofepris advises the general public and health professionals to always verify that the batch number and expiry date on any product packaging match.

The agency requires that if there are doubts about the originality of a product, it is necessary to contact the health registration holder.

If the doctor has provided andl Fake bio If patients experience any adverse reactions or discomfort, they must report it by email to or by calling 800 033 5050.

According to information on the website of the Mexican Institute of Social Security (IMSS), hepatitis B is a life-threatening liver infection Caused by the hepatitis B virus, it is spread through contact with the blood or other body fluids of an infected person and through sexual intercourse. This condition is one of the leading causes of cirrhosis and liver cancer.

It has two stages, acute stage and chronic stage. Most affected people will not experience symptoms during the acute phase. In this case, it can last six months.

Chronic hepatitis B virus infection can be treated with medications, especially oral antivirals. In chronic cases, it can last for more than six months.

this symptom They can develop within four months of infection and include:

  • stomach ache
  • dark urine
  • fever
  • joint pain
  • Loss of appetite
  • nausea and vomiting
  • weakness and fatigue
  • Yellowing of the skin and whites of the eyes (jaundice)
Hepatitis B vaccine should be given to children under 18 months of age; and to persons over 11 years of age.

According to information from the Ministry of Health, the hepatitis B vaccine must be administered by intramuscular injection into the left thigh of boys and girls. 18 months old; or from the age of eleven.

Hepatitis B vaccine is available for girls and boys up to 5 years of age and the schedule consists of 3 doses, the first dose is best given within the first hours of life (in extreme cases within the first 7 days of life); the second dose The first time was when I was 2 months old, and the third time was when I was 6 months old.

If the baby has not been vaccinated within 7 days of birth, vaccines are given at 2, 4 and 6 months of age. All 3 doses are needed to fully protect it.

If the child weighs less than 2 kg at birth, four doses will be given: at birth, at 2 months, 4 months and 6 months.

For adolescents and adults, the vaccine is given as an intramuscular injection in the right arm starting at age 11. In this case, the number of administrations and doses will depend on the regimen.

People who are severely allergic to any component of the vaccine will not be able to get vaccinated; similarly, if the fever exceeds 38.5 degrees, application should be postponed.

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