Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - orthopaedics - matrixneuro plate and screw system is intended for closure and/or bone fixation in the following indications: craniotomies, cranial trauma repair and reconstruction.

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

johnson & johnson medical pty ltd t/a depuy synthes - 46580 - mesh, metallic - matrixneuro preformed mesh plates are intended to be used for cranial closure and/or bone fixation

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

matrix dental services pty ltd - 33204 - matrix band/strip retainer, dental - this is dental device used to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration.

Australia - English - 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.

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

glaxosmithkline australia pty ltd - pertussis toxoid, quantity: 16 microgram/ml; pertussis filamentous haemagglutinin, quantity: 16 microgram/ml; pertactin, quantity: 5 microgram/ml; diphtheria toxoid, quantity: 4 iu/ml; tetanus toxoid, quantity: 40 iu/ml - injection, suspension - excipient ingredients: aluminium hydroxide hydrate; aluminium phosphate; sodium chloride; water for injections - boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see section 4.2 dose and method of administration).,boostrix 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 use of boostrix should be in accordance with official recommendations.

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

glaxosmithkline australia pty ltd - pertussis toxoid, quantity: 16 microgram/ml; tetanus toxoid, quantity: 40 iu/ml; diphtheria toxoid, quantity: 4 iu/ml; pertactin, quantity: 5 microgram/ml; pertussis filamentous haemagglutinin, quantity: 16 microgram/ml - injection, suspension - excipient ingredients: water for injections; aluminium hydroxide hydrate; aluminium phosphate; sodium chloride - boostrix is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals aged four years and older (see section 4.2 dose and method of administration).,boostrix 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 use of boostrix should be in accordance with official recommendations.

United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h), 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) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [iu] in 0.5 ml - boostrix is indicated for:     •    active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,     •    immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. do not administer boostrix to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of boostrix or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine [see description (11)] . encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including boostrix. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to boostrix during pregnancy. healthcare providers are encouraged to register women by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. in a randomized, controlled clinical study (nct02377349), in which the non-u.s. formulation of boostrix was administered during the third trimester of pregnancy, there were no identified vaccine-related adverse effects on pregnancy or on the fetus/newborn child (see data) . available data from the pregnancy registry and from spontaneous and postmarketing reports suggest that the rates of major birth defects and miscarriage in women who received boostrix within 28 days prior to conception or during pregnancy are consistent with estimated background rates (see data) . a developmental toxicity study was performed in female rats administered infanrix prior to mating and boostrix during gestation, 0.1 ml at each occasion (a single human dose is 0.5 ml). in a second study, female rats were administered 0.2 ml of boostrix prior to mating and during the gestation and lactation period. in a third study, female new zealand white rabbits were given 0.5 ml (full human dose) of boostrix (non-u.s. formulation) prior to mating and during gestation. these studies revealed no evidence of harm to the fetus due to boostrix (see data). data human data: safety data from a randomized (1:1), controlled clinical study (nct02377349) (341 non-u.s. formulation of boostrix, 346 placebo pregnancy outcomes) in which the non-u.s. formulation of boostrix was administered to pregnant women during the third trimester did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child. safety data from prospective clinical studies on the use of boostrix during the first and second trimester of pregnancy are not available. an assessment of data from the u.s. pregnancy exposure registry over approximately 17 years (2005-2022) included 1,523 prospective reports of exposure to boostrix within 28 days prior to conception or during pregnancy. among the 256 reports with known pregnancy outcomes, 19 women were exposed to boostrix in the first trimester with no major birth defects reported and 3 spontaneous abortions with no apparent birth defect; 28 women were exposed to boostrix in the second trimester, and 199 women were exposed to boostrix in the third trimester with no major birth defects reported; 10 women were exposed to boostrix at an unknown timing in pregnancy with no major birth defects reported. an assessment of u.s. spontaneous reports and postmarketing data included 810 prospective reports of exposure to boostrix during pregnancy since may 2005 through 31 august 2022. among the 138 reports with known pregnancy outcomes, 17 women were exposed to boostrix in the first trimester with no major birth defects reported and 2 spontaneous abortions with no apparent birth defect; 26 women were exposed to boostrix in the second trimester, and 92 women were exposed to boostrix in the third trimester with no major birth defects reported; 3 women were exposed to boostrix at an unknown timing in pregnancy with no major birth defects reported. animal data: developmental toxicity studies were performed in female rats and new zealand white rabbits. in one study, female rats were administered 0.1 ml of infanrix (a single human dose is 0.5 ml) by intramuscular injection 30 days prior to mating and 0.1 ml of boostrix (a single human dose is 0.5 ml) by intramuscular injection on gestation days 6, 8, 11, and 15. the antigens in infanrix are the same as those in boostrix, but infanrix is formulated with higher quantities of these antigens. in a second study, female rats were administered 0.2 ml of boostrix by intramuscular injection 28 days and 14 days prior to mating, on gestation days 3, 8, 11, and 15, and on lactation day 7. in these studies, no adverse effects on embryo-fetal or pre-weaning development up to postnatal day 25 were observed; there were no fetal malformations or variations observed. in a third study, female new zealand white rabbits were administered 0.5 ml (full human dose) of boostrix (non-u.s. formulation) by intramuscular injection on premating days -28 and -14 and on gestation days 3, 8, 11, 15, and 24. in this study, no adverse effects on embryo-fetal development related to boostrix were observed; postnatal development was not evaluated. risk summary it is not known whether the vaccine components of boostrix are excreted in human milk. data are not available to assess the effect of administration of boostrix on breastfed infants or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for boostrix and any potential adverse effects on the breastfed child from boostrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. boostrix is not indicated for use in children aged younger than 10 years. safety and effectiveness of boostrix in this age group have not been established. in the initial-dose clinical trials, 1,104 subjects aged 65 years and older received boostrix; of these subjects, 299 were aged 75 years and older. adverse events following boostrix were similar in frequency to those reported with the comparator td vaccine [see adverse reactions (6.1)] . a revaccination study of boostrix in adults aged 28 to 73 years [see clinical studies (14.4)] did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

Kenya - English - Pharmacy and Poisons Board

twokay chemicals ltd p.o. box 46169 - 00100 nairobi - each film coated tablet contains: levocetrizine… - tablet - levocetrizine dihydrochloride 5mg - antihistamines for systemic use: piperazine

Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - diphtheria toxoid; filamentous haemagglutinin (fha); inactivated polio virus (ipv) type 1; inactivated polio virus (ipv) type 2; inactivated polio virus (ipv) type 3; pertactin (prn or 69 kda omp); pertussis toxoid vaccine; tetanus toxoid - suspension for injection - pertactin (prn or 69 kda omp) 2.5 mcg / 0.5 ml; diphtheria toxoid nlt 2 iu / 0.5 ml; tetanus toxoid nlt 20 iu / 0.5 ml; filamentous haemagglutinin (fha) 8 mcg / 0.5 ml; pertussis toxoid vaccine 8 mcg / 0.5 ml; inactivated polio virus (ipv) type 3 32 du / 0.5 ml; inactivated polio virus (ipv) type 1 40 du / 0.5 ml; inactivated polio virus (ipv) type 2 8 du / 0.5 ml - bacterial and viral vaccines, combined - for booster vaccination against diphtheria, tetanus and pertusis and poliomyelitis of individuals from the age of three years onwards. the administration of boostrix polio should be based on official recommendations.

United States - English - NLM (National Library of Medicine)

merck sharp & dohme corp. - altrenogest (unii: 2u0x0ja2nb) (altrenogest - unii:2u0x0ja2nb) - oral solution, 2.2 mg altrenogest per ml (0.22%) synthetic progestin for use in swine only for synchronization of estrus in sexually mature gilts that have had at least one estrous cycle. treatment with matrix® results in estrus (standing heat) 4 to 9 days after completion of the 14-day treatment period. it is a violation of federal law to use this drug product other than as directed in the labeling or as directed by your veterinarian.