Australija - engleski - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - haemophilus type b polysaccharide, quantity: 10 microgram; tetanus protein, quantity: 18 microgram - injection, powder for - excipient ingredients: trometamol; sucrose - for use in infants from 2 months to 5 years of age for active immunization against invasive disease caused by the haemophilus influenzae type b.

Filipini - engleski - FDA (Food And Drug Administration)

eurocare pharma, inc. - zinc (as sulfate monohydrate) - syrup - 20mg/5ml (equivalent to 55mg zinc sulfate monohydrate)

Filipini - engleski - FDA (Food And Drug Administration)

n/a; importer: euro generics international phils., inc; distributor: remed pharmaceuticals, inc. - zinc - tablet - 20 mg (equivalent to 57.645 mg zinc sulfate monohydrate)

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

biocon biologics inc. - pegfilgrastim (unii: 3a58010674) (pegfilgrastim - unii:3a58010674) - fulphila is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see clinical studies (14.1)] . fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. fulphila is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. reactions have included anaphylaxis [see warnings and precautions (5.3)] . although available data with fulphila or pegfilgrastim product use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to filgrastim products. these studies have not established an association of filgrastim product use during pregnancy with major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). in pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background 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 2-4% and 15-20%, respectively. retrospective studies indicate that exposure to pegfilgrastim is without significant adverse effect on fetal outcomes and neutropenia. preterm deliveries have been reported in some patients. pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. at cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. no evidence of fetal loss or structural malformations was observed in any study. cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). there are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fulphila and any potential adverse effects on the breastfed child from fulphila or from the underlying maternal condition. the safety and effectiveness of pegfilgrastim have been established in pediatric patients. no overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see clinical pharmacology (12.3) and clinical studies (14.1)] . of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. no overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

bracco diagnostics inc. - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide 5 ug in 5 ml - kinevac is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. kinevac is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

sanofi pasteur inc. - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen (unii: flv5i5w26r) (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen - unii:flv5i5w26r) - haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - acthib® is a vaccine indicated for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. acthib is approved for use in children 2 months through 5 years of age. severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of acthib vaccine [see description (11)] . acthib is not approved for use in individuals 6 years of age and older. no human or animal data are available to assess vaccine-associated risks in pregnancy. acthib is not approved for use in individuals 6 years of age and older. human or animal data are not available to assess the impact of acthib on milk production, its presence in breast milk, or its effects on the breastfed infant. safety and effectiveness of acthib have not been established in infants below the age of 6 weeks and children and adolescents 6 years of age and older [see dosage and administration (2.1)] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen (unii: c9r35m8xv6) (haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen - unii:c9r35m8xv6) - haemophilus influenzae type b strain 20752 capsular polysaccharide tetanus toxoid conjugate antigen 10 ug in 0.5 ml - hiberix is indicated for active immunization for the prevention of invasive disease caused by haemophilus influenzae (h. influenzae) type b. hiberix is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). severe allergic reaction (e.g., anaphylaxis) after a previous dose of any h. influenzae type b- or tetanus toxoid-containing vaccine or any component of the vaccine is a contraindication to administration of hiberix [see description (11)] . safety and effectiveness of hiberix in children younger than 6 weeks and in children aged 5 to 16 years have not been established.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - nortriptyline hydrochloride (unii: 00fn6ih15d) (nortriptyline - unii:bl03sy4lxb) - nortriptyline hydrochloride, usp is indicated for the relief of symptoms of depression. endogenous depressions are more likely to be alleviated than are other depressive states. the use of maois intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of nortriptyline hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting nortriptyline hydrochloride in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings and dosage and administration ). cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. nortriptyline hy

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline hydrochloride capsules, usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) due to chlamydophila psittaci. - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - nongonococcal urethritis, endocervical, or rectal infections in adults caused by ureaplasma urealyticum or chlamydia trachomatis . - relapsing fever due to borrelia recurrentis . - chancroid caused by haemoph

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i), polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - this product is contraindicated in those individuals who have shown hypersensitivity to any of its components.