Quinvaxem inj.

(DTP-HepB-Hib fully liquid combined vaccine)

1. NAME OF THE MEDICINAL PRODUCT
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine), suspension for injection.
Diphtheria, Tetanus, Pertussis, Hepatitis B recombinant and Haemophilus influenzae type b (Hib) combined vaccine.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) is a ready-to-use, fully liquid combined vaccine containing diphtheria and
tetanus toxoids, Bordetella pertussis inactivated cellular suspension, hepatitis B surface antigen (HBsAg), and Haemophilus influenzae
type b conjugated oligosaccharide.
The diphtheria and tetanus toxoids are obtained from Corynebacterium diphtheriae and Clostridium tetani cultures, respectively, by
formaldehyde inactivation and purification. The pertussis suspension component is obtained from B. pertussis cultures after inactiva-
tion and purification.
The hepatitis B surface antigen is produced in genetically engineered yeast cells (Hansenula polymorpha) carrying the relevant gene
of the HBsAg. The antigen is purified and inactivated by several physicochemical steps.
The H. influenzae type b component is made of purified capsular oligosaccharides conjugated to CRM 197 (Cross Reacting Material),
a non-toxic mutant of diphtheria toxin, prepared from C. diphtheriae cultures.
The vaccine contains aluminium phosphate as adjuvant, forming a whitish sediment.
One 0.5 mL dose of vaccine contains:
Purified Diphtheria toxoid .................................................................................................................................. not less than 30 IU
Purified Tetanus toxoid ...................................................................................................................................... not less than 60 IU
Inactivated B. pertussis ........................................................................................................................................ not less than 4 IU
Hib oligosaccharide ................................................................................................10 µg, conjugated to approx. 25 µg of CRM 197
Hepatitis B surface antigen, purified .......................................................................................................................................10 µg
Aluminium phosphate (adjuvant).................................................................................................................................... 0.3 mg Al3+

Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) is free of preservative. Thiomersal may be present in traces as a residue
of the manufacturing process.
For list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Suspension for intramuscular injection.
After shaking, the product has a milky appearance.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Active primary and booster immunisation of infants and toddlers for protection against diphtheria, tetanus, pertussis, hepatitis B, and
invasive illness caused by H. influenzae type b. The vaccine is indicated for infants regardless of whether or not they have received hep-
atitis B vaccination at birth. Based on available evidence and recommendations it is concluded, that Quinvaxem inj. (DTP-HepB-Hib
fully liquid combined vaccine) can, like similar combination vaccines, be used in infants interchangeably for basic immunisation with
other DTP-HepB-Hib vaccines, or components thereof, as well as for boosting children primed in infancy with another combination vac-
cine.
4.2 Posology and method of administration
4.2.1 Dosage
Applicable national vaccination recommendations and/or the WHO guidelines are to be followed.
Primary vaccination of infants (first year of life): 3 doses of 0.5 mL each, at least one month apart, starting as early as 6 weeks
of age.
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) can be given to children who have received hepatitis B vaccine at birth.
Reinforcing vaccination of toddlers (13–24 months after birth): one booster dose of 0.5 mL.
4.2.2 Method of administration
The vaccine is to be administered by intramuscular injection in the anterolateral thigh or alternatively in the deltoid region in children
13–24 months after birth. In some indications (e.g. haemorrhagic diathesis) the vaccine can be given subcutaneously (see section 4.4).
The vaccine can be administered simultaneously, as a separate injection, with other common childhood vaccines, according to locally
recommended immunisation schedules.
4.3 Contraindications
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) should not be administered to children with known hypersensitivity to
any vaccine component or to children having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, per-
tussis, hepatitis B, or Hib vaccines.
Children who have experienced an encephalopathy of unknown aetiology after a previous vaccination with vaccine containing pertus-
sis should not be vaccinated with Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine). In these circumstances, the vaccina-
tion course should be continued with diphtheria, tetanus, hepatitis B, and Hib vaccines.
As with other vaccines, vaccination should be postponed in children suffering from acute febrile illness. Minor illnesses, such as the
common cold or other infections of the upper respiratory tract, are not to be considered contraindications to vaccination. Equally, it is
not necessary to postpone vaccination in the case of treatment with topical corticosteroids or systemic use of corticosteroids at low
dosage (<0.5 mg/kg of prednisone or equivalent) or in case of skin diseases like dermatitis, eczema, or other localised skin disorders.
4.4 Special warnings and precautions for use
As with any injectable vaccine, appropriate medical supervision and treatment, including 1:1000 adrenaline and other appropriate
medical treatment, should always be readily available in case of immediate allergic reactions, such as anaphylactic shock or anaphy-
lactic reaction, following administration of the vaccination.
Before administering the vaccine, precautions should be taken to avoid undesirable reactions. These precautions include: review of the
individual’s medical history, particularly regarding hypersensitivity reactions to previous administration of any type of vaccine, as well
as the individual’s history of recent health disorders and any previous vaccinations.
The administration of any subsequent dose of a vaccine containing the whole-cell pertussis component should be carefully considered
if, in connection with the administration of DTP vaccine, one or more of the following effects have been observed:
– 40.0 °C temperature within 48 hours following vaccination (not due to other identifiable causes);
– collapse or shock (hypotonic hyporesponsive episodes) within 48 hours following vaccination;
– persistent crying lasting more than 3 hours during the 48 hours following vaccination;
– convulsions, with or without fever, within 3 days following vaccination.
There may be circumstances, such as high incidence of pertussis, when potential benefits outweigh possible risks.
HIV seropositivity does not represent a contraindication to vaccination. Patients with an immunodeficiency disorder or receiving im-
munosuppressive therapy may have a reduced immunological response.
The vaccine must not be injected into a blood vessel.
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) should be administered subcutaneously in patients with known severe
thrombocytopenia or bleeding disorders since bleeding after intramuscular injection may occur in these individuals.
4.5 Interaction with other medicinal products and other forms of interaction
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) can be administered simultaneously with other vaccines (injectable or
oral) at separate sites or in any temporal relationship with other paediatric vaccines if this fits conveniently in the immunisation sched-
ule. Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) must not be mixed with other vaccines in the same syringe.
The immunological response may be reduced in patients undergoing immunosuppressive or corticosteroid treatment (see section 4.4).
4.6 Pregnancy and lactation
Not applicable. Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) is a paediatric vaccine.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Approximately 1500 doses of Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) have been administered in clinical trials as
a primary vaccination in healthy infants from six weeks of age. In these clinical studies, signs and symptoms were actively monitored
in all subjects for five to seven days following the administration of the vaccine.
Solicited and unsolicited reported reactions are listed below. Frequencies are reported as:
Very common (>1/10), Common (>1/100, ≤1/10), Uncommon (>1/1000, ≤1/100), Rare (>1/10 000, ≤1/1000), Very rare (≤1/10 000,
incl. isolated reports).
Gastrointestinal disorders:
Common: diarrhoea, vomiting
General disorders and administration site conditions:
Very common: injection site reactions (erythema, induration, pain)
Common: fever
Rare: influenza-like illness
Metabolism and nutrition disorders:
Common: feeding disorders
Nervous system disorders:
Common: sleepiness
Psychiatric disorders:
Very common: crying
Common: irritability
Uncommon: persistent crying
Respiratory, thoracic and mediastinal disorders:
Rare: coughing
Skin and subcutaneous tissue disorders:
Uncommon: rash
The systemic adverse reactions usually appeared within 48 hours after vaccination and in most cases disappeared spontaneously. All
local and systemic reactions resolved without sequelae.
Allergic reactions, including anaphylactic reactions and urticaria, have been reported very rarely following vaccination with DTP, hep-
atitis B and Hib containing vaccines.
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Results form clinical studies show that more than 97% of children are protected against diphtheria, tetanus, pertussis, and invasive
illnesses caused by H. influenzae type b after a three-dose primary vaccination course with Quinvaxem inj. (DTP-HepB-Hib fully liquid
combined vaccine). More than 91% of children are protected against hepatitis B when the vaccine is administered using the most im-
munologically demanding vaccination schedule (6–10–14 weeks, without hepatitis B vaccination at birth). It is known that hepatitis
B seroprotection rates are influenced by the vaccination schedule used – increasing age at first vaccination and longer intervals be-
tween the second and third vaccinations generally result in higher final anti-HBs antibody titres.
5.2 Pharmacokinetic properties
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride, water for injection ad 0.5 mL.
6.2 Incompatibilities
The vaccine must not be mixed with other medicinal products.
6.3 Shelf life
Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine) has a shelf life of 36 months from the date of manufacture when stored
at a temperature between +2 °C and +8 °C.
The expiry date is indicated on the labels and packaging.
6.4 Special precautions for storage
Store at a temperature between +2 °C and +8 °C.
Do not freeze. Discard if vaccine has been frozen.
6.5 Nature and contents of containers
Neutral glass vial, type I, containing 0.5 mL of vaccine (1 dose) with a rubber stopper (chlorobutyl).
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such
medicinal product and other handling of the product
Important: shake well before use.
7. MARKETING AUTHORISATION HOLDER
GreenCross Vaccine Corporation
227-3 Kugal-Ri, Kiheung-Eup, Yongin 449-903, South Korea
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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