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DESCRIPTION
PENTAVAC SD/MD (Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B (rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed) I.P.)
supplied by Serum Institute of India Ltd., in a single dose (SD) or a
multi-dose (MD) vial is a homogeneous liquid containing purified
diphtheria and tetanus toxoids, inactivated whooping cough (pertussis)
organisms, highly purified, noninfectious
particles of Hepatitis B surface antigen (HBsAg) and Hib component as
a bacterial subunit vaccine containing highly purified, non-infectious
Haemophilus influenzae type b (Hib) capsular polysaccharide
chemically conjugated to a protein (Tetanus Toxoid). Surface antigen
of the Hepatitis B virus (HBV) is obtained by culturing genetically
engineered Hansenula polymorpha yeast cells having the surface
antigen gene of the Hepatitis B virus.
The Hepatitis B surface antigen (HBsAg) expressed in the cells of
Hansenula polymorpha using recombinant DNA procedures is purified
through several chemical steps. Thiomersal is added as preservative.
The vaccine meets the requirements of WHO when tested by the methods
outlined in WHO, TRS 786 (1989) and 800 (1990). The Hib polysaccharide
is prepared from capsular polysaccharide of H. influenzae type
b strain and after activation is coupled to Tetanus Toxoid.
Each dose of 0.5 ml contains:
PENTAVAC SD/MD does not prevent Hepatitis
caused by other agents different from HBV (as virus A, C and E) but
it is considered effective in preventing Hepatitis caused by the
delta agent. Hib vaccine does not protect against disease due to
other types of H.influenzae nor against meningitis caused by
other organisms.
INDICATIONS
PENTAVAC SD/MD is indicated for the active immunization of infants, at
or above the age of 6 weeks against Diphtheria, tetanus, whooping
cough, Hepatitis B and Haemophilus influenzae type b
infections.
In young children the EPI recommends as many antigens as possible to
be administered at a single visit.
PENTAVAC SD/MD should NOT be used for the birth dose.
The combined vaccine can be given safely and effectively at the same
time as BCG, MMR, Measles and Polio vaccines (OPV and IPV), Yellow
fever vaccines and Vitamin A supplementation.
DOSAGE AND ADMINISTRATION
For active immunization of infants and preschool children, it is
recommended that three intramuscular injections of 0.5 ml be
administered with an interval of four weeks between doses starting
at six weeks of age. In countries where perinatal transmission of
Hepatitis B virus is common, the first dose of Hepatitis B vaccine
should be given as soon as possible after birth. In this case,
the combination vaccine can be used to complete the primary series
from 6 weeks of age.
|
Dose |
Age at immunization |
|
1st dose |
6 weeks |
|
2nd dose |
10 weeks |
|
3rd dose |
14 weeks |
Source: WHO / IAP recommended
immunization schedule. A booster dose of DTP and Hib should be given
at the age of 15-18 months.
A reinforcing injection of DTP should be administered at 5 years of
age (i.e. at the time of school entry). IAP (Indian Academy of
Pediatrics) recommends that wherever combination vaccines are
available they can be substituted for monovalent formulations in the
national immunisation schedule wherever indicated.
ADMINISTRATION
The liquid vaccine ampoule/vial should be shaken before use to
homogenize the suspension. The vaccine should be injected
intramuscularly. Do not inject subcutaneously or intravenously. The
anterolateral aspect of the upper thigh is the preferred site of
injection, or into the deltoid muscles of older children. An
injection into a child's buttocks may cause injury to the sciatic
nerve and is not recommended. It must not be injected into the skin
as this may give rise to local reactions. One pediatric dose is 0.5
ml. A sterile syringe and sterile needle must be used for the
injection.
Another injection if co-administered with PENTAVAC SD/MD should be
given at a different site. Only sterile needles and syringes should
be used for each injection. Once opened, multi-dose vials should be
kept between +2°C and +8°C. Multi-dose vials of Diphtheria, Tetanus,
Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus Type b
Conjugate Vaccine (Adsorbed) I.P. from which one or more doses of
vaccine have been removed during an immunisation session may be used
in subsequent immunisation sessions for upto a maximum of 4 weeks,
provided that all of the following conditions are met:
The expiry date has not
passed.
The vaccines are stored
under appropriate cold chain conditions.
The vaccine vial septum
has not been submerged in water.
Aseptic technique has
been used to withdraw all doses.
The vaccine should be visually inspected for any foreign particulate
matter and /or variation of physical aspect prior to administration.
In event of either being observed discard the vaccine. Pentavac
SD/MD should not be mixed with any other vaccine before injection.
CONTRAINDICATIONS
Hypersensitivity to any component of the vaccine. It is a
contraindication to use this or any other related vaccine after an
immediate anaphylactic reaction associated with a previous dose. It
is a contraindication to administer the vaccine in the presence of
any evolving neurological condition. Encephalopathy after a previous
dose is a contraindication to further use. Immunization should be
deferred during the cause of an acute illness. Vaccination of
infants and children with severe, febrile illness should generally
be deferred until recovery. However, the presence of minor illnesses
such as mild upper respiratory infections with or without low grade
fever is not a contraindication for further use.
WARNINGS
Due to the long incubation period of Hepatitis B (upto 6 months or
more), cases where prior exposure to Hepatitis B virus has taken
place, vaccination may not be effective. If any of the following
events occur in temporal relation to receipt of PENTAVAC SD/MD, the
decision to give subsequent doses of vaccine containing the
pertussis component should be carefully considered.
Temperature 40.5°C (105°F) or more within 48 hours of a dose
unexplained by another cause. Collapse or shock-like state
(hypotonic-hypo responsive episode) within 48 hours. Persistent,
inconsolable crying lasting 3 hours or more occurring within 48
hours. Convulsions with or without fever occurring within three
days. There may be circumstances, such as a high incidence of
pertussis, when the potential benefits outweigh possible risks,
particularly since these events are not associated with permanent
sequelae. PENTAVAC SD/MD should not be given to children with any
coagulation disorder, including thrombocytopenia that would
contraindicate intramuscular injection unless the potential benefit
clearly outweighs the risk of administration. Infants and children
with a history of convulsions in first-degree family members (i.e.
siblings and parents) when administered DTP containing vaccine have
an increased risk for neurologic events and permanent neurologic
damage when compared with infants without such history. Infants and
children with recognized possible or potential underlying neurologic
conditions seem to be at enhanced risk for the appearance of
manifestation of the underlying neurologic disorder within two or
three days following vaccination.
The administration of PENTAVAC SD/MD to children with proven or
suspected underlying neurologic disorders that are not actively
evolving must be decided on an individual basis.
PRECAUTIONS
Prior to an injection of any vaccine, all known precautions should
be taken to prevent adverse reactions. This includes a review of the
parent's history with respect to possible sensitivity and any
previous adverse reactions to the vaccine or similar vaccines.
Previous immunization history, current health status and a current
knowledge of the literature concerning the use of the vaccine under
consideration. Immunosuppressed children may not respond.
Prior to administration of PENTAVAC SD/MD, health care personnel
should inform the guardian of the child the benefits and risks of
immunization, and also inquire about the recent health status of the
child to be injected. Parents of a child with a family history of
seizures should be informed that their child has an increased risk
of seizures following administration of any DTP containing vaccine
and should be instructed regarding appropriate medical care in the
unlikely event of a seizure. Special care should be taken to ensure
that the injection does not enter a blood vessel.
Adrenaline injection (1:1000) must be immediately available should
an acute anaphylactic reaction occur due to any component of the
vaccine. For treatment of severe anaphylaxis the initial dose of
adrenaline is 0.1- 0.5 mg (0.1-0.5ml of 1:1000 injection) given s/c
or i/m. Single dose should not exceed 1 mg (1 ml). For infants and
children the recommended dose of adrenaline is 0.01mg/kg (0.01ml/kg
of 1:1000 injection). Single pediatric dose should not exceed 0.5mg
(0.5 ml). The mainstay in the treatment of severe anaphylaxis is the
prompt use of adrenaline, which can be lifesaving.
As with the use of all vaccines, the vaccinee should remain under
observation for not less than 30 minutes for possibility of
occurrence of immediate or early allergic reactions. Efcorlin
hydrochloride and antihistaminics should also be available in
addition to supportive measures such as oxygen inhalation.
DRUG INTERACTIONS
As with other intramuscular injections, use with caution in patients
on anticoagulant therapy. Immunosuppressive therapies, including
irradiation, antimetabolites, alkylating agents, cytotoxic drugs,
and corticosteroids (used in greater than physiologic doses)may
reduce the immune response to vaccines.
Short-term (< 2 weeks) corticosteroid therapy or intra-articular,
bursal, or tendon injections with corticosteroids should not be
immunosuppressive.
ADVERSE REACTIONS
Adverse reactions associated with the use of this vaccine include
local redness, warmth, oedema, and induration with or without
tenderness, as well as urticaria and rash. Systemic reactions such
as fever, headache, drowsiness, weakness, fretfulness, nausea,
vomiting, diarrhoea and anorexia may occur in a few infants. Some
data suggests that febrile reactions are more likely to occur in
those who have experienced such responses after prior doses of DTP
vaccine.
High fever (i.e. temperature of 40.5°C (105°F) and persistent,
inconsolable crying lasting 3 hours or more has been reported. These
events occur infrequently and appear to be without sequelae.
Occasionally, a nodule may be palpable at the injection site of
adsorbed products for several weeks. Sterile abscesses at the site
of injection have been reported (6 to 10 per million doses). In
study conducted on PENTAVAC, the frequency of local and systemic
reactions was not higher with subsequent doses and was well within
the range of other DTP containing vaccines.
Evidence does not indicate a causal relation between DTP vaccine and
SIDS. Studies showing a temporal relation between these events are
consistent with the expected occurrence of SIDS over the age range
in which DTP immunization typically occurs. No association has been
shown for hospitalizations due to infectious diseases and receipt of
DTP.
NERVOUS SYSTEM
The following neurologic illnesses have been reported as temporally
associated with vaccine containing tetanus toxoid; neurological
complications including cochlear lesion, brachial plexus
neuropathies, paralysis of the radial nerve, paralysis of the
recurrent nerve, accommodation paresis, and EEG disturbances with
encephalopathy. It has been suggested that there is a causal
relation between Guillain-Barre syndrome (GBS) and vaccines
containing tetanus toxoid. In the differential diagnosis of
polyradiculoneuropathies administration of a vaccine containing
tetanus toxoid should be considered as a possible etiology.
Short-lived convulsions (usually febrile), or collapse (hypotonic
hyporesponsive episode) occur infrequently and appear to be without
sequelae.
More severe neurologic events, such as a prolonged convulsion, or
encephalopathy, although rare, have been reported in temporal
association with DTP administration. An analysis of these data
failed to show any cause and effect association.
CARDIOVASCULAR SYSTEM
An infant who developed myocarditis several hours after immunization
has been reported.
RESPIRATORY SYSTEM
Respiratory difficulties including apnea have been observed.
LOCAL
Rash and allergic reactions have been observed.
IMMUNE DEFICIENCY
Individuals infected with the human immuno-deficiency virus (HIV),
both asymptomatic and symptomatic, should be immunized with combined
vaccine according to standard schedules.
STORAGE
The vaccine should be stored at a temperature between +2°C and +8°C
(35.6° to 46.4°F). NOT TO BE FROZEN. Product which has been exposed
to freezing should not be used.
SHELF LIFE
Do not exceed the expiry date stated on the external packaging.
PRESENTATION
0.5 ml -1 dose ampoule
0.5 ml -1 dose vial
1 ml - 2 doses vial
2.5 ml – 5 doses vial
5 ml – 10 doses vial
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20
Lf to 
30
Lf