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DESCRIPTION
QUADROVAX (Diphtheria, Tetanus, Pertussis (Whole Cell) 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 Sii Triple Antigen (Diphtheria, Tetanus and
Pertussis Vaccine (Adsorbed) I.P.) liquid as a diluent.
Triple Antigen (Liquid) as supplied by Serum Institute of India Ltd.,
is sterile, opaque, uniform suspension of diphtheria toxoid, tetanus
toxoid and killed Bordetella pertussis bacilli. Thiomersal is added as
preservative.
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 Triple Antigen
On reconstitution
Each dose of 0.5 ml contains:
QUADROVAX does not protect against disease due to
other types of H.influenzae nor against meningitis caused by other
organisms.
INDICATIONS
QUADROVAX is indicated for the active immunization of infants, at or
above the age of 6 weeks against Diphtheria, tetanus whooping cough
and Haemophilus Influenzae type b infections.
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, Polio vaccines (OPV and IPV), Yellow Fever
vaccine and Vitamin A supplementation.
DOSAGE
For active immunization of infants and
preschool children, it is recommended that three intramuscular
injections of 0.5ml be administered with an interval of four weeks
between doses starting at six weeks of age.
A booster dose of DTP 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:
The vaccine is administered after the Sii HibPRO powder contained in
the vial is reconstituted with one ampoule (0.5ml) of Triple Antigen
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 Triple Antigen 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 vaccine (2, 5 and 10 doses)
powder with the suspension contained in the ampoule/vial of Triple
Antigen(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 disinfectent. For each new dose extract 0.5ml using a new
sterile syringe fitted with a sterile needle. Between the different
extraction 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 QUADROVAX 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 QUADROVAX 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.
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 are not contraindications
to further use. Elective immunization procedures should be deferred
during an outbreak of poliomyelitis.
WARNINGS
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.
In the event of edematous reactions of the lower limbs occurring
following an injection of a vaccine containing the Haemophilus
influenzae type b component, QUADROVAX should be administered at two
seperate injection sites on two different days.
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 QUADROVAX, 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 DTPw 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 paediatric 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.
PREGNANCY - BREAST FEEDING
As a general rule, during pregnancy and breast
feeding, it is recommended to always see your doctor for advice
before taking a medicinal product.
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 at a temperature between +2°C and +8°C.
Transportation should also be at +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
QUADROVAX is supplied as :
Carton containing 1 dose vial of Sii HibPRO (freeze-dried) + 1 dose
(0.5ml) ampoule of Triple Antigen (liquid)
Carton containing 2 doses vial of Sii HibPRO (freeze-dried) + 2
doses (1ml) ampoule of Triple Antigen (liquid)
Carton containing 5 doses vial of Sii HibPRO (freeze-dried) + 5
doses (2.5ml) vial of Triple Antigen (liquid)
Carton containing 10 doses vial of Sii HibPRO (freeze-dried) + 10
doses (5ml) vial of Triple Antigen (liquid)
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20
Lf to 
30
Lf