Malta - Kiingereza - 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

Malta - Kiingereza - 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

Marekani - Kiingereza - NLM (National Library of Medicine)

sanofi pasteur inc. - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (glutaraldehyde inactivated) (unii: f4tn0ipy37) (bordetella pertussis toxoid antigen (glutaraldehyde inactivated) - unii:f4tn0ipy37 - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 15 [lf] in 0.5 ml - pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenzae type b. pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). a severe allergic reaction (eg, anaphylaxis) after a previous dose of pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or h. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of pentacel. [see description (11). ] encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pentacel. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progres

Marekani - Kiingereza - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) (unii: qsn5xo8zsu) (bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) - unii:qsn5xo8zsu), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) (unii: 8c367iy4ey) (bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) - unii:8c367iy4ey), bordetella pertussis pertactin antigen (formaldehyde inactivated) (unii: i05o535nv6) (bordetella pertussis pertactin antigen (formaldehyde inactivated) - unii:i05o535nv6), hepatitis b virus subtype adw2 hbsag surface protein antigen (unii: 9gcj1l5d1p) (hepatitis b virus subtype adw2 hbsag surface protein antigen - unii:9gcj1l5d1p), poliovirus type 1 antigen (formaldehyde inactivated) (unii: 0lvy784c09) (poliovirus type 1 antigen (formaldehyde inactivated) - unii:0lvy784c09), poliovirus type 2 antigen (formaldehyde inactivated) (unii: 23je9kdf4r) (poliovirus type 2 antigen (formaldehyde inactivated) - unii:23je9kdf4r), poliovirus type 3 antigen (formaldehyde inactivated) (unii: 459rom8m9m) (poliovirus type 3 antigen (formaldehyde inactivated) - unii:459rom8m9m) - corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) 25 [iu] in 0.5 ml - pediarix is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis b virus, and poliomyelitis. pediarix is approved for use as a 3-dose series in infants born of hepatitis b surface antigen (hbsag)-negative mothers. pediarix may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis b-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin b, is a contraindication to administration of pediarix [see description (11)] . encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including pediarix. progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including pediarix. pediarix should not be administered to individuals with such conditions until the neurologic status is clarified and stabilized. safety and effectiveness of pediarix were established in the age group 6 weeks through 6 months on the basis of clinical studies [see adverse reactions (6.1), clinical studies (14.1, 14.2)] . safety and effectiveness of pediarix in the age group 7 months through 6 years are supported by evidence in infants aged 6 weeks through 6 months. safety and effectiveness of pediarix in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

Malta - Kiingereza - Medicines Authority

glaxosmithkline biologicals s.a. rue de l'institut 89 b-1330 rixensart, belgium - pertactin, pertussis filamentous, haemagglutinin, pertussis toxoid, poliovirus, inactivated, type, mahoney strain, mef, saukett strain, diphtheria toxoid, haemophilus influenzae, type b, polysaccharide, polyribosylribitol phosphate, tetanus toxoid - powder and suspension for suspension for injection - pertactin 8 µg pertussis filamentous haemagglutinin 25 µg pertussis toxoid 25 µg poliovirus (inactivated) type 1 (mahoney strain) 40 dagu/0.5ml poliovirus (inactivated) type 2 (mef-1 strain) 8 dagu/0.5ml poliovirus (inactivated) type 3 (saukett strain) 32 dagu/0.5ml diphtheria toxoid haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) 10 µg tetanus toxoid - vaccines

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

sanofi pasteur - purified diphtheria toxoid ph. eur.; purified tetanus toxoid; adsorbed purified pertussis toxoid; adsorbed purified filamentous haemagglutinin; inactivated poliomyelitis virus ph. eur; inactivated type 1 poliovirus; inactivated type 2 poliovirus; inactivated type 3 poliovirus; haemophilus influenzae type b, conjugate with tetanus protein - powder for suspension for injection - 0.5 millilitre(s) - diphtheria-hemophilus influenzae b-pertussis-poliomyelitis-tetanus

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

aj vaccines a/s - diphtheria toxoid, purified; tetanus toxoid, purified; pertussis toxoid, purified - suspension for injection in pre-filled syringe - < 2 international unit(s) - pertussis vaccines; pertussis, purified antigen, combinations with toxoids

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - diphtheria toxoid, adsorbed 15 lf u; haemophilus influenzae type b polysaccharide 10ug; pertactin 3ug (adsorbed); pertussis filamentous haemagglutinin 20ug (adsorbed); pertussis fimbriae 2+3 5ug (adsorbed); pertussis toxoid, adsorbed 20ug; polio virus type 1 40 dagu (mahoney, inactivated); polio virus type 2 8 dagu (m e f 1, inactivated); polio virus type 3 32 dagu (saukett, inactivated); tetanus toxoid 20ug (covalently bound to hib prp); tetanus toxoid, adsorbed 5 lf u - suspension for injection - active: diphtheria toxoid, adsorbed 15 lf u haemophilus influenzae type b polysaccharide 10ug pertactin 3ug (adsorbed) pertussis filamentous haemagglutinin 20ug (adsorbed) pertussis fimbriae 2+3 5ug (adsorbed) pertussis toxoid, adsorbed 20ug polio virus type 1 40 dagu (mahoney, inactivated) polio virus type 2 8 dagu (m e f 1, inactivated) polio virus type 3 32 dagu (saukett, inactivated) tetanus toxoid 20ug (covalently bound to hib prp) tetanus toxoid, adsorbed 5 lf u excipient: aluminium phosphate bovine serum albumin formaldehyde glutaral neomycin phenoxyethanol polymyxin b sulfate polysorbate 80 streptomycin water for injection - pediacel is indicated for the primary immunisation of children from 6 weeks of age against diphtheria, tetanus, pertussis, poliomyelitis and invasive haemophilus influenzae type b disease. pediacel® is also indicated for the fourth dose for children from 15 months of age up to 20 months who have been immunised previously with up to three doses of diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b disease vaccines.

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - diphtheria toxoid, adsorbed 15 lf u; pertactin 3ug (adsorbed); pertussis filamentous haemagglutinin 20ug (adsorbed); pertussis fimbriae 2+3 5ug (adsorbed); pertussis toxoid, adsorbed 20ug; polio virus type 1 40 dagu (inactivated); polio virus type 2 8 dagu (inactivated); polio virus type 3 32 dagu (inactivated); tetanus toxoid, adsorbed 5 lf u; haemophilus influenzae type b polysaccharide 10ug (conjugated to tetanus protein (18-30µg)) - combination - active: diphtheria toxoid, adsorbed 15 lf u pertactin 3ug (adsorbed) pertussis filamentous haemagglutinin 20ug (adsorbed) pertussis fimbriae 2+3 5ug (adsorbed) pertussis toxoid, adsorbed 20ug polio virus type 1 40 dagu (inactivated) polio virus type 2 8 dagu (inactivated) polio virus type 3 32 dagu (inactivated) tetanus toxoid, adsorbed 5 lf u excipient: aluminium phosphate bovine serum albumin formaldehyde glutaral neomycin phenoxyethanol polymyxin b polysorbate 80 water for injection active: haemophilus influenzae type b polysaccharide 10ug (conjugated to tetanus protein (18-30µg)) excipient: sucrose trometamol - poliacel® is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, whooping cough, poliomyelitis and invasive haemophilus influenzae type b disease. poliacel® is also indicated for the fourth dose for children from 15 to 20 months who have been immunised previously with up to three doses of diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b disease vaccines.

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - diphtheria toxoid, adsorbed 30 [iu] (minimum per dose; 15 lf (not less than 1 usphs unit per dose)); pertactin 3ug; pertussis filamentous haemagglutinin 5ug; pertussis fimbriae 2+3 5ug; pertussis toxoid, adsorbed 10ug; tetanus toxoid, adsorbed 40 [iu] (minimum per dose; 5 lf (not less than 1 usphs unit per dose)) - suspension for injection - 0.5 ml - active: diphtheria toxoid, adsorbed 30 [iu] (minimum per dose; 15 lf (not less than 1 usphs unit per dose)) pertactin 3ug pertussis filamentous haemagglutinin 5ug pertussis fimbriae 2+3 5ug pertussis toxoid, adsorbed 10ug tetanus toxoid, adsorbed 40 [iu] (minimum per dose; 5 lf (not less than 1 usphs unit per dose)) excipient: aluminium phosphate phenoxyethanol water for injection - tripacel® is indicated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age; tripacel® is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.