Vaksin Pentabio (DTP-HB-Hib)

Pentabio is a DTP-HB-Hib combination vaccine in forms of homogenous suspension containing: Diphtheria toxoid and pure tetanus, inactive Pertussis bacteria (whooping cough), non-infectious pure Hepatitis B surface antigen (HBsAg) and non-infectious HiB component which is a conjugation result between polysaccharide subunit of Haomophilus influenza type B and tetanus toxoid.

HBsAg protein is produced through yeast DNA recombination. The polysaccharide subunit is originally from Hib bacteria grown in a particular media, which is then purified through several steps of ultrafiltration. Vaccine is sequestered in aluminum phosphate. Thimerosal acts as preserving agent.

Vaccine potential per dosage is less that 4IU for pertussis, 30 IU for diphtheria, 60 IU for tetanus (determined in rat) or 40 IU determined in guinea pig, 10mcg HBsAg and 10 mcg Hib.

COMPOSITION

Each dose (0.5 mL) contains

Active substance

Pure Diphtheroid Toxoid 20 Lf (k.30 IU)

Pure Tetanus Toxoid 5 Lf 60 IU)

B. pertussis inaktif 12 OU (k 4 IU)

HBsAg 10 mcg

Conjugate Hib 10 mcg

Additives

as 0.33 mg aluminum phosphate

Thimerosal 0.025 mg

INDICATION

Vaccines are used for the prevention of diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and Haemophilus influenzae type b infection simultaneously.

HOW TO WORK DRUG

Stimulates the body to form antibodies against diphtheria-i, tetanus, pertussis, hepatitis B, and Haemophilus influenza type b.

WAY OF GIVING

Vaccines should be injected intramuscularly. Injection should be performed on the anterolateral upper thighs. Injections in the child's buttocks can cause sciatic nerve injuries and are not recommended. Injections should not be given into the skin as it may increase local reactions. One dose of the child is 0.5 mL.

 

SIDE EFFECTS

The types and rates of severe adverse reaction events did not differ significantly with the DTP vaccine, Hepatitis B and Hib administered separately. For DTP, mild local and systemic reactions are common. Some temporary local reactions such as swelling, pain and redness at the injection site with fever may occur in a large number of cases. Sometimes severe reactions such as high fever, irritability (fussiness), and high-pitched crying can occur within 24 hours after administration. Hypotonic-hyporesponsive episodes have been reported. Febrile seizures have been reported with an incidence of 1 case per 12,500 dose of administration. Administration of acetaminophen at and 4-8 hours after immunization reduces the occurrence of fever. Studies conducted by a number of groups including the United States Institute of Medicine, The Advisory Committee on Immunization Practices, and association of pediatricians in Australia, Canada, UK and America, concluded that the data did not show any causal relationship between DTP and chronic nervous system dysfunction in children. Therefore, there is no scientific evidence that such reactions have a permanent effect on children.

Hepatitis B vaccine is well tolerated. In the study using placebo as a control, in addition to local pain, reported occurrences such as myalgia and rheumatic fever were no more frequent than in the placebo group. Reports of severe anaphylactic reactions are very rare. Existing data do not show any causal relationship between hepatitis B vaccine and syndrome or demyelination damage including multiple sclerosis disorders, and also no epidemiological data to support a causal link between hepatitis B vaccination and chronic fatigue syndrome, arthritis, autoimmune disorders, asthma, death syndrome sudden on baby, or diabetes.

Hib vaccine is well tolerated. Local reactions can occur within 24 hours after vaccination where the vaccine control can feel pain at the injection site. This reaction is usually mild and temporary. In general, it will heal by itself in two or three days, and does not require further medical treatment. A mild systemic reaction, including fever, is rare after injection of the Hib vaccine. Other heavy reactions are very rare; the causality relationship between other heavy reactions and vaccines has never been established.

CONTRAINDICATIONS

Hypersensitive to vaccine components, or severe reactions to previous combined vaccine doses or other similar forms of reaction are absolute contraindications to subsequent doses. There are several contraindications to the first dose of DTP; seizures or symptoms of brain abnormalities in newborns or other serious neurological disorders are contraindicated to the pertussis component. In this case, the vaccine should not be fished as a combination vaccine, but the DT vaccine should be given in lieu of DTP, Hibitis B and Hib vaccine administered separately. The vaccine will not harm individuals who have or have previously been infected with the hepatitis B virus.

Deficiency of the immune system

Individuals infected with human-immunodeficiency virus (HIV), either asymptomatic or symptomatic, should be immunized with combination vaccines according to the standard schedule.

WARNING AND CAUTION

  • Vaccine vials should be avoided beforehand to homogenize suspensions. - Use a sterile syringe for each injection.
  • This vaccine should not be mixed in one vial or syringe with another vaccine.
  • Before the vaccine is used, information on the Vaccine Vial Monitor (VVM) image should be followed.

STORAGE

The DTP-HB-Hib vaccine should be stored and transported at temperatures between + 2 ° C and .8 ° C. The DTP-HB-HIb vaccine is NOT DIABLE.

Vaccines from dual-dose vial packs taken one or more doses in one immunization session can be used for the next immunization session for up to 4 weeks, if the following conditions are met (as stated in WHO policy) The use of opened multi-dose vials in subsequent immunization sessions WHOIVEr13 / 00.09):

  • Not past the expiration limit
  • Vaccines are kept in the right cold chain condition
  • The vialvaccine lid is not immersed in water
  • All doses are taken aseptically
  • If there is a Vaccine Wal Monitor (WM), it does not reach the discard point (see figure)
  • PACKAGING
  • Dus @ 10 vial @ 0.5 mL (1 dose); Reg. No. DKL1302906943A1 Dus @ 10 vial @ 2.5 mL (5 doses); Fteg. No. : DKL1302906943A1 Dus @ 10 vial @ 5 mL (10 doses); Reg. No. DKL1302906943A1
  • GBR. VACCINE VIAL MONITOR
  • Vaccine Vial Monitor (VVM) is a part of the time-temperature sensitive Pentabio (Vaccine DTP-HB-Hib) dosage and serves as an indicator of the accumulation of heat exposure experienced by vials (valcsin). This is a clue to the user whether the vaccine can still be used or not.
  • VVM readability is easy. Focus on the box in the middle of the circle. The color will change gradually. The same color of the box is younger than the circle then the vaccine can still be used. If the color of the box is the same or darker than the circle, then the vaccine should be immediately discarded.