Nova Zelândia - inglês - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - anti-beta hcg monoclonal antibody - pregnancy test kit - active: anti-beta hcg monoclonal antibody

Malta - inglês - Malta Medicines Authority

bio products laboratory limited - anti, d immunoglobulin, human - solution for injection - anti-d immunoglobulin, human 250 international unit(s)/millilitre - immune sera and immunoglobulins

Estados Unidos - inglês - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - anti-inhibitor coagulant complex (unii: cs849dun3m) (anti-inhibitor coagulant complex - unii:cs849dun3m) - anti-inhibitor coagulant complex 500 [usp'u] in 20 ml - feiba is an anti-inhibitor coagulant complex indicated for use in hemophilia a and b patients with inhibitors for: - control and prevention of bleeding episodes - perioperative management - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. feiba is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor viii or coagulation factor ix. - known anaphylactic or severe hypersensitivity reactions to feiba or any of its components, including factors of the kinin generating system. - disseminated intravascular coagulation (dic). - acute thrombosis or embolism (including myocardial infarction). risk summary there are no data with feiba use in pregnant women to inform a drug-associated risk. there are no adequate and well-controlled studies in pregnant women. animal reproduction studies have not been conducted with feiba. it is also not known whether feiba can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. in the u.s. general population, the estimated background risk for major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information available on the effect of feiba on labor and delivery. risk summary there is no information regarding the presence of feiba in human milk, the effect on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for feiba and any potential adverse effects on the breastfed child from feiba or from the underlying condition. safety and efficacy of feiba have been evaluated in nine pediatric subjects treated in the routine prophylaxis trial including 4 subjects ≥7 to <12 years of age and 5 subjects ≥12 to <16 years of age. the dosing for all pediatric subjects was based on body weight. a total of 576 infusions were given for the treatment of 223 bleeding episodes (504 infusions for joint bleeding episodes, 72 infusions for muscle and soft tissue bleeding episodes). in 223 (100%) of the episodes, hemostasis was achieved with one or more infusions. hemostatic efficacy was rated as excellent or good in a majority (96.9%) of the bleeding episodes in both regimens at 24 hours post infusion. the median annualized bleeding episode rate (abr) for children ≥7 to <12 years of age was 7.7 bleeds per patient per year, as compared to 39 for subjects treated with on-demand therapy [see clinical studies (14)] . the safety and efficacy of feiba has not been evaluated in neonates. the safety and efficacy of feiba has not been evaluated in subjects ≥65 years of age.

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

bayer plc - interferon beta-1b - powder and solvent for solution for injection - 300microgram

Austrália - inglês - APVMA (Australian Pesticides and Veterinary Medicines Authority)

qpharma pty ltd - tetracycline hydrochloride - oral solution/suspension - tetracycline hydrochloride antibiotic active 200.0 g/kg - antibiotic & related - birds - ornamental | domestic birds | amazon parrot | aviary bird | budgerigar | cage birds | caged bird | canary | cockatiel | - bacterial enteritis | tetracycline sensitive bacteria | post-weaning bacterial enterit

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - anti-d (rho) immunoglobulin - solution for injection - 500unit

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - anti-d (rho) immunoglobulin - solution for injection - 1500unit

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

bio products laboratory ltd - anti-d (rho) immunoglobulin - solution for injection - 2500unit

Estados Unidos - inglês - NLM (National Library of Medicine)

carilion materials management - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - varenicline 1 mg - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix pregnancy category c. there are no adequate and well-controlled studies of chantix use in pregnant women. in animal studies, chantix caused decreased fetal weights, increased auditory startle response, and decreased fertility in offspring. chantix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproductive and developmental toxicity studies, pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. these exposures were 36 (rats) and 50 (rabbits) times the human exposure (based on auc) at the maximum recommended human dose (mrhd) of 1 mg twice daily. while no fetal structural abnormalities occurred in either species, reduced fetal weights occurred in rabbits at the highest dose (e

Estados Unidos - inglês - NLM (National Library of Medicine)

paladin laboratories (usa) inc - fomepizole (unii: 83lcm6l2by) (fomepizole - unii:83lcm6l2by) - fomepizole 1 g in 1 ml - antizol®  is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see dosage and administration ). antizol®  should not be administered to patients with a documented serious hypersensitivity reaction to antizol®  or other pyrazoles.