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DESCRIPTION
PENTAVAC (Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis
B(rDNA) and Haemophilus Type b Conjugate Vaccine (Adsorbed) I.P.) is
composed of Sii HibPRO (Haemophilus Type b Conjugate Vaccine I.P.) as
a freeze dried powder which is reconstituted using liquid SII Q-VAC
(Diphtheria, Tetanus, Pertussis(Whole Cell) and Hepatitis B (rDNA)
Vaccine (Adsorbed) I.P.) as a diluent.
SII Q-VAC supplied by Serum Institute of India Ltd., is sterile,
opaque, uniform suspension of diphtheria toxoid, tetanus toxoid,
killed Bordetella pertussis bacilli and Hepatitis B surface antigen
adsorbed on aluminum gel and suspended in isotonic sodium chloride
solution. 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 is purified through several chemical steps using
recombinant DNA procedures. Thiomersal is added as preservative. The
vaccine meets the requirements of I.P. when tested by the methods
outlined in I.P.
The Hib polysaccharide is prepared from capsular polysaccharide of H.
influenzae type b strain and after activation is coupled to Tetanus
Toxoid.
Reconstitute Sii HibPRO with SII Q-VAC
On reconstitution
Each dose of 0.5 ml contains:
PENTAVAC 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. Sii HibPRO does not protect against disease due to
other types of H.influenzae nor against meningitis caused by other
organisms.
INDICATIONS
PENTAVAC is indicated for the active immunization of infants, at or
above the age of 6 weeks of birth and of children through 6 years of
age against Diphtheria, tetanus, whooping cough, Hepatitis B and Hib.
In young children the EPI recommends as many antigens as possible to
be administered at a single visit.
The combined vaccine can be given safely and effectively at the same
time as BCG, Measles and Polio vaccines (OPV and IPV), Yellow Fever
vaccines and Vitamin A supplementation.
DOSAGE
For active immunization of infants and pre-school children, it is
recommended that three intramuscular injection of 0.5 ml be
administered with an interval of four weeks between doses. Although
the customary age for first dose of primary immunization is two
months but is now recommended to be given at 6 weeks of age. A
booster dose of DTwP and Hib can 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
Do not inject subcutaneously or intravenously.
For a single-dose presentation:
PENTAVAC is administered after the Sii HibPRO powder contained in
the vial is reconstituted with one ampoule (0.5ml) of SII Q-VAC
suspension, shake until the powder has completely dissolved without
producing too much foam.
The whitish cloudy appearance of the suspension after reconstitution
is normal.
For a multidose presentation:
Since the SII Q-VAC vaccine is adsorbed, it is first of all
necessary to shake the vial gently to avoid foam formation, but
sufficiently to ensure that the product is mixed homogeneously.
Reconstitute the vial of Sii HibPRO (2, 5 and 10 doses) powder with
the suspension contained in the ampoule/vial of SII Q-VAC (1,2.5 and
5ml) using a sterile syringe fitted with a sterile needle. The
whitish cloudy appearance of the suspension after reconstitution is
normal. This preparation is equivalent to 2, 5 and 10 doses.
Successful reconstitution and extraction of one or more doses of
vaccine from a multidose vial essentially depends on the quality of
the operation. The user must, using a sterile 1ml or 0.5ml syringe
with a sterile needle extract one dose (0.5ml) from the multidose
vial, on which the outer surface of the stopper has been disinfected
with a disinfectant. For each new dose extract 0.5ml using a new
sterile syringe fitted with a sterile needle. Between the different
extractions the vial should be placed in a refrigerator to keep the
product at its normal storage temperature i.e. between +2°C and
+8°C.
The vaccine vial should be well shaken to get an opaque suspension.
The vaccine should be administered by intramuscular injection. The
anterolateral aspect of the thigh is the preferred injection site
for infants and deltoid for children.
Another injection if co-administered with PENTAVAC vaccine should be
made at a different site. Only sterile needles and syringes should
be used for each injection.
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.
Once opened, multi-dose vials should be kept between +2°C and +8°C.
Multi-dose vials of PENTAVAC 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 6 hours,
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 course 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 are not contraindications
to further use. Elective immunization procedures should be deferred
during an outbreak of poliomyelitis.
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 DTP, the decision to give subsequent doses of vaccine containing
the pertussis component should be carefully considered. 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.
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Temperature 40.5°C (105°F) or more within
48 hours of a dose unexplained by another cause.
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Collapse or shock-like state (hypotonic-hyporesponsive
episode) within 48 hours.
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Persistent, inconsolable crying lasting 3
hours or more occurring within 48 hours
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Convulsions with or without fever
occurring within three days.
Persons who experience Arthus-type
hypersensitivity reactions or a temperature of 39.4°C ( > 103° F)
following a prior dose of tetanus toxoid usually have high serum
tetanus antitoxin levels and should not be given even emergency
doses of TT more frequently than every 10 years even if they have a
wound that is neither clean not minor.
DTP 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.
Recent studies suggest that infants and children with a history of
convulsions in first-degree family members (i.e. siblings and
parents) have a 3:2 fold increased risk for neurologic events
compared to DTP vaccine and permanent neurologic damage.
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 DTP 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 patients may not respond.
Prior to administration of PENTAVAC, health care personnel should
inform the patient or guardian of the patient the benefits and risks
of immunization, and also inquire about the recent health status of
the patient 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 DTP administration 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 (1ml). 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 (0.5ml). 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.
DRUGINTERACTIONS
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, edema, and induration with or without
tenderness, as well as urticaria and rash. Systemic reactions such
as fever, headache, nausea and weakness may appear in a few
subjects. Some data suggests that febrile reactions are more likely
to occur in those who have experienced such responses after prior
doses.
Mild systemic reactions such as fever, drowsiness, fretfulness and
anorexia occur quite frequently. Rarely, an anaphylactic reaction
(i.e. hives, swelling of the mouth, difficulty in breathing,
hypertension or shock and death) have been reported after receiving
preparations containing diphtheria, tetanus and / or pertussis
antigens.
Moderate to severe systemic events, including high fever (i.e.
temperature of 40.5°C (105°F) and persistent, inconsolable crying
lasting 3 hours or more. These events occur infrequently and appear
to be without sequalae.
Exceptionally acute encephalopathy (neurological disease.)
Neurological disorders following vaccination tend to be attributed
to the pertussis component.
Edematous reactions of the lower limbs. These reactions are
sometimes accompanied by fever, pain and crying.
LOCAL
Rash and allergic reactions have been observed.
Hib vaccine is very well tolerated. Localized reactions may occur
within 24 hours of vaccination, when recipients may experience pain
and tenderness at the injection site. These reactions are generally
mild and transient. In most cases, they spontaneously resolve within
two to three days and further medical attention is not required.
Mild systemic reactions, including fever, rarely occur following
administration of Hib vaccine. More serious reactions are very rare;
a causal relationship between more serious reactions and the vaccine
has not been established.
STORAGE OF THE VACCINE
The vaccine should be stored in a dry, dark place at a temperature
between +2°C and +8°C. Transportation should also be between +2°C
and +8°C. Not to be frozen.
SHELF LIFE
The expiry date of the vaccine is indicated on the label and
packaging.
PRESENTATION
PENTAVAC is supplied as :
Carton containing 1 dose vial of Sii HibPRO (freeze-dried) + 1 dose
(0.5ml) ampoule of SII Q-VAC (liquid)
Carton containing 2 doses vial of Sii HibPRO (freeze-dried) + 2
doses (1ml) ampoule of SII Q-VAC (liquid)
Carton containing 5 doses vial of Sii HibPRO (freeze-dried) + 5
doses (2.5ml) vial of SII Q-VAC (liquid)
Carton containing 10 doses vial of Sii HibPRO (freeze-dried) + 10
doses (5ml) vial of SII Q-VAC (liquid)
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20
Lf to 
30
Lf