Malta - English - Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 8 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 25 µg tetanus toxoid - vaccines

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi pasteur - tetanus toxoid; diphtheria toxoid; pertussis toxoid; filamentous haemagglutinin (fha); pertactin; polio virus type 1 inactivated; polio virus type 2 inactivated; polio virus type 3 inactivated; adsorbed aluminium phosphate; adsorbed fimbriae types 2 + 3 - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - bacterial and viral vaccines, combined; diphtheria-pertussis-poliomyelitis-tetanus

Malta - English - Medicines Authority

bilthoven biologicals b.v. antonie van leeuwenhoeklaan 9 3721 ma, bilthoven, netherlands - suspension for injection - poliovirus (inactivated) type 3 (saukett strain) 7.5 dagu diphtheria toxoid >5 iu tetanus toxoid >20 iu poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 4 dagu - vaccines

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - inactivated poliomyelitis virus type 1 (mahoney); inactivated poliomyelitis virus type 2 (mef-1); inactivated poliomyelitis virus type 3 (saukett) - injection - 8 d.u. - inactivated poliomyelitis virus type 1 (mahoney) 40 d.u./0.5 ml; inactivated poliomyelitis virus type 2 (mef-1) 8 d.u./0.5 ml; inactivated poliomyelitis virus type 3 (saukett) 32 d.u./0.5 ml

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - polio virus type 1 29 dagu (mahoney by parallel line method (equiv to 40 dagu by sigmoid method)); polio virus type 2 7 dagu (mef1 by parallel line method (equiv to 8 dagu by sigmoid method)); polio virus type 3 26 dagu (saukett by parallel line method (equiv to 32 dagu by sigmoid method)) - suspension for injection - active: polio virus type 1 29 dagu (mahoney by parallel line method (equiv to 40 dagu by sigmoid method)) polio virus type 2 7 dagu (mef1 by parallel line method (equiv to 8 dagu by sigmoid method)) polio virus type 3 26 dagu (saukett by parallel line method (equiv to 32 dagu by sigmoid method)) excipient: formaldehyde phenoxyethanol polysorbate 80 water for injection - ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. recommendations for the use of live and inactivated poliovirus vaccines are described in the national immunisation guidelines. 1. general recommendations. it is recommended that all infants, unimmunised children and adolescents not previously immunised be vaccinated routinely against paralytic poliomyelitis. ipol should be offered to patients who have refused opv, or in whom opv is contraindicated. 2. ipol is also indicated for: · the primary vaccination of immunocompromised individuals of all ages (see precautions), and household contacts of such individuals (when vaccination is indicated) · unvaccinated or inadequately vaccinated (*) adults, particularly if at increased risk of exposure to live poliovirus, including: · travellers to areas or countries where poliomyelitis is epidemic or endemic; · laboratory workers handling specimens which may contain polioviruses; · health care workers in close contact with patients who may be excreting polioviruses. (*) such as those who had not completed a primary series of vaccination or not received a booster dose since infancy.

Canada - English - Health Canada

sanofi pasteur limited - inactivated poliomyelitis vaccine (d.c.o.) type 2 mef1; inactivated poliomyelitis vaccine (d.c.o.) type 3 saukett; inactivated poliomyelitis vaccine (d.c.o.) type 1 mahoney - solution - 8unit; 32unit; 40unit - inactivated poliomyelitis vaccine (d.c.o.) type 2 mef1 8unit; inactivated poliomyelitis vaccine (d.c.o.) type 3 saukett 32unit; inactivated poliomyelitis vaccine (d.c.o.) type 1 mahoney 40unit - vaccines

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - 45156 - medicine administration kit, percutaneous, medicated, single-use - adacel polio procedure pack contains a syringe pre-filled with a single dose of vaccine (pertussis vaccine - acellular diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus type 1,2 and 3 (vero cell)) and two separate needles of varying size. these separate needles are supplied to enable the vaccinator to choose the appropriate needle size for the injection of vaccine to the vaccinee. this is a single-use only product.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - diphtheria toxoid, adsorbed 30 [iu] (not less than); hepatitis b surface antigen, recombinant 10ug; pertactin 8ug;  ; pertussis filamentous haemagglutinin 25ug;  ; pertussis toxoid, adsorbed 25ug;  ; polio virus type 1 40 dagu (/dose);  ; polio virus type 2 8 dagu (/dose);  ; polio virus type 3 32 dagu (/dose);  ; tetanus toxoid, adsorbed 40 [iu] (not less than); haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms);   - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (not less than) hepatitis b surface antigen, recombinant 10ug pertactin 8ug   pertussis filamentous haemagglutinin 25ug   pertussis toxoid, adsorbed 25ug   polio virus type 1 40 dagu (/dose)   polio virus type 2 8 dagu (/dose)   polio virus type 3 32 dagu (/dose)   tetanus toxoid, adsorbed 40 [iu] (not less than) excipient: aluminium medium 199 sodium chloride water for injection active: haemophilus influenzae vaccine, tetanus toxoid conjugate 10ug (covalently bonded to tetanus toxoid 20 - 40micrograms)   excipient: aluminium as aluminium phosphate lactose - infanrix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and haemophilus influenzae type b.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - pertussis toxoid; filamentous haemagglutinin; pertactin; diphtheria toxoid; tetanus toxoid; polio virus type 1 inactivated; polio virus type 2 inactivated; polio virus type 3 inactivated - suspension for injection in pre-filled syringe - 0.5 millilitre(s) - diphtheria-pertussis-poliomyelitis-tetanus

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - pertactin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, filamentous haemagglutinin, fha, fimbriae types, and, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - suspension for injection in pre-filled syringe - pertactin 3 µg pertussis toxoid 20 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu poliovirus (inactivated) type 3 (saukett strain) 32 dagu diphtheria toxoid filamentous haemagglutinin (fha) 20 µg fimbriae types 2 and 3 5 µg haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines