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Euvax B (Pediatric) 0.5ml
Add to WishlistEuvax B consists of highly purified, non infect......
Euvax B consists of highly purified, non infectious particles of Hepatitis B surface antigen (HBsAg) adsorbed onto aluminum salts as an adjuvant and preserved with thimerosal. It is a recombinant DNA hepatitis B vaccine derived from HBsAg produced by DNA recombinant technology in yeast cells (Saccharomyces cerevisiae).
The vaccine meets the WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in its manufacture.
COMPOSITION
1 ml of the above vaccine contains :
– Active ingredient : Purified HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 µg
– Adjuvant :Aluminum Hydroxide Gel (as Al) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg
– Preservative :Thimerosal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.01 w/v%
– Excipients : Potassium phosphate, monobasic, Sodium phosphate, dibasic, Sodium chloride.
INDICATION AND USAGE
Immunization against infection caused by all known subtypes of Hepatitis B virus.
DOSAGE AND ADMINISTRATION
Euvax B is for intramuscular use only.
– One pediatric dose (neonates, infants, and children aged up to and including 15 years of age) is 0.5 ml containing 10 µg of HBsAg.
The immunization regimen consists of three doses of vaccine given according to the following schedule;
– 1st dose : at elected date
– 2nd dose : 1 month after the first dose
– 3rd dose : 6 months after the first dose
ADVERSE REACTIONS
Common :
– Local reactions such as erythema, pain, swelling or minor fever may rarely occur; these symptoms disappear in 2 days.
Rare :
– Hyperthermia (above 38.8°C).
– Systemic reactions such as malaise, asthenia, headache, nausea, vomiting, dizziness, myalgia, arthritis
– Skin rash and transient increase of transaminases.
Very rare :
– A causal sequence of cause and effect could not be established for reports of multiple neuritis, optic neuritis,
facial paralysis, exacerbation of multiple sclerosis, and Guillain-Barré syndrome.
STORAGE CONDITIONS
Do not exceed the expiry date stated on the external packaging. Store between + 2° C and +8° C (in a refrigerator). Do not freeze.
This medicine is Prescription Only Medicine (POM ) and required under medical supervision.
ဤဆေးသည် POM ဆေးအုပ်စုတွင်ပါဝင်သောကြောင့် ဆရာဝန်ညွှန်ကြားချက်အတိုင်းသာ သုံးစွဲသင့်ပါသည်။
Size : 0.5ml
Description
Euvax B (Pediatric) 0.5ml
Euvax B consists of highly purified, non infectious particles of Hepatitis B surface antigen (HBsAg) adsorbed onto aluminum salts as an adjuvant and preserved with thimerosal. It is a recombinant DNA hepatitis B vaccine derived from HBsAg produced by DNA recombinant technology in yeast cells (Saccharomyces cerevisiae).
The vaccine meets the WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in its manufacture.
COMPOSITION
1 ml of the above vaccine contains :
– Active ingredient : Purified HBsAg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 µg
– Adjuvant :Aluminum Hydroxide Gel (as Al) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.5 mg
– Preservative :Thimerosal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.01 w/v%
– Excipients : Potassium phosphate, monobasic, Sodium phosphate, dibasic, Sodium chloride.
INDICATION AND USAGE
Immunization against infection caused by all known subtypes of Hepatitis B virus.
DOSAGE AND ADMINISTRATION
Euvax B is for intramuscular use only.
– One pediatric dose (neonates, infants, and children aged up to and including 15 years of age) is 0.5 ml containing 10 µg of HBsAg.
The immunization regimen consists of three doses of vaccine given according to the following schedule;
– 1st dose : at elected date
– 2nd dose : 1 month after the first dose
– 3rd dose : 6 months after the first dose
ADVERSE REACTIONS
Common :
– Local reactions such as erythema, pain, swelling or minor fever may rarely occur; these symptoms disappear in 2 days.
Rare :
– Hyperthermia (above 38.8°C).
– Systemic reactions such as malaise, asthenia, headache, nausea, vomiting, dizziness, myalgia, arthritis
– Skin rash and transient increase of transaminases.
Very rare :
– A causal sequence of cause and effect could not be established for reports of multiple neuritis, optic neuritis,
facial paralysis, exacerbation of multiple sclerosis, and Guillain-Barré syndrome.
STORAGE CONDITIONS
Do not exceed the expiry date stated on the external packaging. Store between + 2° C and +8° C (in a refrigerator). Do not freeze.
This medicine is Prescription Only Medicine (POM ) and required under medical supervision.
ဤဆေးသည် POM ဆေးအုပ်စုတွင်ပါဝင်သောကြောင့် ဆရာဝန်ညွှန်ကြားချက်အတိုင်းသာ သုံးစွဲသင့်ပါသည်။
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