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

maxx pharma pty ltd - pegfilgrastim, quantity: 6 mg - injection, solution - excipient ingredients: sorbitol; sodium; water for injections; polysorbate 20; acetate - fulphila is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia.

Ireland - English - HPRA (Health Products Regulatory Authority)

glaxosmithkline (ireland) limited - haemophilus influenzae type b polysaccharide; conjugate of haemophilus influenzae type b capsular polysaccharide (prp) and tetanus toxoid - powder and solvent for solution for injection - 0.5 millilitre(s) - hemophilus influenzae b, combinations with toxoids

Philippines - English - FDA (Food And Drug Administration)

zuellig pharma corporation - haemophilus influenzae type b polysaccharide conjugated to tetanus protein - lyophilized powder for solution (im/sc) - 10 mcg/0.5ml

Philippines - English - FDA (Food And Drug Administration)

phil pharmawealth, inc. - ampicillin (as sodium) - powder for injection - 100 mg

Philippines - English - FDA (Food And Drug Administration)

phil pharmawealth, inc. - amoxicillin (as trihydrate) - capsule - 500 mg

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

mylan institutional llc - 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.

United States - English - 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.

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

Malta - English - Medicines Authority

sanofi pasteur 14 espace henry vallée , 69007 lyon, france - tetanus toxoid, diphtheria toxoid, haemophilus type, b polysaccharide, polyribosylribitol phosphate, conjugated to, as carrier, protein, bordetella pertussis - powder and suspension for suspension for injection - diphtheria toxoid haemophilus type b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus toxoid as carrier protein 10 µg bordetella pertussis 4 iu tetanus toxoid 60 iu - vaccines

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

homeocare laboratories - haemophilus influenzae type b (unii: f2tw0n64fi) (haemophilus influenzae type b - unii:f2tw0n64fi) - haemophilus influenzae type b 9 [hp_c] in 29.5 ml