האיחוד האירופי - אנגלית - EMA (European Medicines Agency)

astrazeneca ab - a/darwin/9/2021 (h3n2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h1n1)pdm09 - like strain (a/victoria/1/2020, medi 340505) / b/austria/1359417/2021 - like strain (b/austria/1359417/2021, medi 355292) / b/phuket/3073/2013 - like strain (b/phuket/3073/2013, medi 306444) - influenza, human - influenza vaccines, influenza, live attenuated - prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. the use of fluenz tetra should be based on official recommendations.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - measles vaccine 1000 tcid50 (edmonston b strain (3 log per dose)); mumps virus, jeryl-lynn strain 19952 tcid50 (b level (4.3 log per dose)); rubella virus, wistar ra27/3 strain 1000 tcid50 ((3 log per dose) ); varicella vaccine 9772 pfu (oka/merck strain (3.99 log per dose));   - injection with diluent - 0.5 ml - active: measles vaccine 1000 tcid50 (edmonston b strain (3 log per dose)) mumps virus, jeryl-lynn strain 19952 tcid50 (b level (4.3 log per dose)) rubella virus, wistar ra27/3 strain 1000 tcid50 ((3 log per dose) ) varicella vaccine 9772 pfu (oka/merck strain (3.99 log per dose))   excipient: dibasic potassium phosphate dibasic sodium phosphate gelatin minimum essential medium eagle medium 199 monosodium glutamate phenolsulfonphthalein potassium chloride sodium bicarbonate sodium chloride sorbitol sucrose urea water for injection - proquad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - varicella vaccine 1350 pfu (oka/merck);   - injection with diluent - 1350 pfu - active: varicella vaccine 1350 pfu (oka/merck)   excipient: dibasic sodium phosphate dodecahydrate gelatin monobasic potassium phosphate monosodium glutamate potassium chloride sodium chloride sucrose urea water for injection - varivax is indicated for vaccination against varicella in individuals 12 months of age and older.

ישראל - אנגלית - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); haemophilus b; hepatitis b vaccines; pertactin; pertussis toxoid (pt); poliovirus type 1 inactivated; poliovirus type 2 inactivated; poliovirus type 3 inactivated; tetanus toxoid - powder and suspension for suspension for injection - filamentous haemagglutinin (fha) 25 mcg/dose; diphtheria toxoid nlt 30 iu/dose; tetanus toxoid nlt 40 iu/dose; hepatitis b vaccines 10 mcg/dose; poliovirus type 1 inactivated 40 du/dose; poliovirus type 2 inactivated 8 du/dose; poliovirus type 3 inactivated 32 du/dose; haemophilus b 10 mcg/dose; pertactin 8 mcg/dose; pertussis toxoid (pt) 25 mcg/dose - bacterial and viral vaccines, combined - infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - tetanus protein, quantity: 22 microgram; haemophilus type b polysaccharide, quantity: 12 microgram; pertussis toxoid, quantity: 25 microgram; diphtheria toxoid, quantity: 20 iu; poliovirus, quantity: 8 dagu; poliovirus, quantity: 40 dagu; tetanus toxoid, quantity: 40 iu; pertussis filamentous haemagglutinin, quantity: 25 microgram; poliovirus, quantity: 32 dagu; hepatitis b surface antigen, quantity: 10 microgram - injection, suspension - excipient ingredients: sucrose; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; water for injections; aluminium hydroxide hydrate; trometamol; tyrosine; arginine hydrochloride; histidine; isoleucine; leucine; lysine hydrochloride; phenylalanine; threonine; tryptophan; valine; cystine; methionine - hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and invasive infections caused by haemophilus influenzae type b. use of this vaccine should be in accordance with the national recommendation as per the current immunisation handbook.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - diphtheria toxoid,pertactin,pertussis filamentous haemagglutinin,pertussis fimbriae 2 + 3,pertussis toxoid,poliovirus,tetanus toxoid -

הממלכה המאוחדת - אנגלית - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; human poliovirus type 3 inactivated - suspension for injection

הממלכה המאוחדת - אנגלית - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - diphtheria toxoid; tetanus toxoid; pertussis antigens; human poliovirus type 1 inactivated; human poliovirus type 2 inactivated; human poliovirus type 3 inactivated; haemophilus influenzae type b polysaccharide protein conjugate - powder and suspension for suspension for injection

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - diphtheria toxoid, quantity: 2 iu; pertussis toxoid, quantity: 8 microgram; tetanus toxoid, quantity: 20 iu; pertactin, quantity: 2.5 microgram; pertussis filamentous haemagglutinin, quantity: 8 microgram; poliovirus, quantity: 32 agu - injection, suspension - excipient ingredients: polysorbate 80; aluminium hydroxide hydrate; sodium chloride; neomycin sulfate; water for injections; aluminium phosphate; polymyxin b sulfate; glucose monohydrate; ascorbic acid; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium - boostrix-ipv is indicated for booster vaccination against diphtheria, tetanus, pertussis and polio of individuals from the age of four years onwards.,boostrix-ipv is also indicated for passive protection against pertussis in early infancy following maternal immunisation during pregnancy (see section 4.2 dose and method of administration, section 4.6 fertility, pregnancy and lactation and 5.1 pharmacodynamic properties).,the nhmrc currently recommends only 4 doses of polio vaccines in childhood, and that polio boosters for adults are not necessary unless they are at special risk, such as:,? travellers to areas or countries where poliomyelitis is epidemic or endemic;,? health care workers in possible contact with poliomyelitis cases.,for those exposed to continuing risk of infection a single booster dose is desirable every 10 years.,the nhmrc currently recommends boosting against diphtheria, tetanus and pertussis using an adolescent/adult formulation dtpa at 15 to 17 years of age. before the eighth birthday, dtp-containing vaccines should be given, as they contain a larger dose of diphtheria toxoid. after the eighth birthday, smaller doses of toxoid (adult/adolescent formulation dtpa or dt-containing vaccines) should be given.,a booster dose of dtpa is also recommended:,? before planning pregnancy, or for both parents as soon as possible after delivery of an infant,? for adults working with young children,? for any adult expressing an interest in receiving a booster dose of dtpa, provided that a primary course of dtp vaccine has been given in the past.,clinical data has demonstrated that in adults with an unknown history of pertussis vaccination, the majority had an immunogenic response to pertussis when given boostrix-ipv (see section 5.1 pharmacodynamic properties).,finally, all adults who reach the age of 50 years without having received a boosting dose of dt in the previous 5 years should receive a further boosting dose of dt, where the adult/adolescent formulation dtpa can be used instead.,boostrix-ipv is not intended for primary immunisation.

סינגפור - אנגלית - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - (prefilled syringe) diphtheria toxoid; (prefilled syringe) filamentous haemagglutinin; (prefilled syringe) pertussis toxoid; (prefilled syringe) poliovirus (inactivated) - type 1 (mahoney); (prefilled syringe) poliovirus (inactivated) - type 2 (mef-1); (prefilled syringe) poliovirus (inactivated) - type 3 (saukett); (prefilled syringe) tetanus toxoid; (vial) haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein; (vial) tetanus protein (prp-t) - injection, powder, for suspension - (prefilled syringe) diphtheria toxoid min. 20 iu (30 lf)/0.5 ml; (prefilled syringe) filamentous haemagglutinin 25 μg/0.5 ml; (prefilled syringe) pertussis toxoid 25 μg/0.5 ml; (prefilled syringe) poliovirus (inactivated) - type 1 (mahoney) 40 du/0.5 ml; (prefilled syringe) poliovirus (inactivated) - type 2 (mef-1) 8 du/0.5 ml; (prefilled syringe) poliovirus (inactivated) - type 3 (saukett) 32 du/0.5 ml; (prefilled syringe) tetanus toxoid min. 40 iu (10 lf) /0.5 ml; (vial) haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein 10 μg/0.5 ml; (vial) tetanus protein (prp-t) 18 - 30 μg/0.5 ml