Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

plasvacc pty ltd - equine gamma globulins - parenteral liquid/solution/suspension - equine gamma globulins vaccine active 22.0 g/l - immunotherapy - horse foal - increase gamma globulin levels of foals

New Zealand - English - Ministry for Primary Industries

plasvacc pty ltd - equine gamma globulins - equine gamma globulins 22 g/litre - immune stimulant

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

plasvacc pty ltd - equine gamma globulins - unknown - equine gamma globulins vaccine active 0.0 - active constituent

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

pfizer australia pty ltd - equine antithymocyte immunoglobulin, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; glycine; hydrochloric acid - indications as at 11 april 2002 : atgam is indicated for renal transplant patients in whom reduction of peripheral t-lympocyte function as measured by rosette-forming cell assay could be desirable. during controlled clinical trials, this immunosuppression has been demonstrated in renal allograft recipients treated with atgam. when it was administered prophylactically with conventional immunosuppressive therapy, atgam delayed the onset of the first rejection episode, and when it was administered at the time of the first rejection, atgam resolved the acute rejection episode more frequently than did conventional therapy alone.

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

pharmacia & upjohn company llc - equine thymocyte immune globulin (unii: 475247qf1z) (equine thymocyte immune globulin - unii:475247qf1z) - equine thymocyte immune globulin 50 mg in 1 ml - atgam is indicated for the management of allograft rejection in renal transplant patients; when administered with conventional therapy at the time of rejection atgam increases the frequency of resolution of the acute rejection episode [see clinical studies (14.1)] . atgam is indicated for the treatment of moderate to severe aplastic anemia in patients unsuitable for bone marrow transplantation [see clinical studies (14.2)] . the usefulness of atgam has not been demonstrated in patients with aplastic anemia who are suitable candidates for bone marrow transplantation or in patients with aplastic anemia secondary to neoplastic disease, storage disease, myelofibrosis, fanconi's syndrome, or in patients known to have been exposed to myelotoxic agents or radiation. do not administer atgam to a patient who has had an anaphylactic reaction during prior administration of atgam or any other equine gamma globulin preparation [see warnings and precautions (5.1)]. risk summary there are no adequate and well-controlled studies in pregnant women. there is a limited amount of data from the use of atgam in pregnant women. it is also not known whether atgam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. the outcome of pregnancies cannot be determined. use atgam during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. 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 outcome. 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. data in embryo-fetal toxicity studies, atgam was administered to rats and cynomolgus monkeys for 11 and 16 days, respectively during organogenesis. in rats, hypoplastic cervical vertebrae, a finding consistent with delayed skeletal development, were observed in fetuses whose dams received atgam at doses of 100 mg/kg/day during organogenesis. in monkey reproduction studies, maternal toxicity (vaginal bleeding, decreased body weight and loss of appetite) was observed with atgam doses ≥20 mg/kg/day after 16 days of dosing. fetal deaths occurred in dams treated with 20 mg/kg/day atgam earlier in organogenesis (days 20‑35), but not when treatment was given at a later part of organogenesis (days 35-50). the maternal and fetal deaths were attributed to maternal anemia due to red blood cell antigen that humans do not share. therefore, this toxicity is not considered relevant to human fetal development. risk summary it is not known if atgam is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breast-feeding neonates and infants from atgam, a decision should be made whether to discontinue breast-feeding or to discontinue the drug taking into account the importance of the drug to the mother. data in animal studies, a single dose of atgam up to 40 mg/kg was not detected at the limit of quantification in the milk of lactating cynomolgus monkeys. contraception females it is not known if atgam can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with atgam and for at least 10 weeks after cessation of therapy. males advise males with a female partner of reproductive potential to use effective contraception during treatment with atgam and for at least 10 weeks after cessation of therapy. infertility in fertility studies, atgam at doses 10, 20 and 40 mg/kg/day was administered to cynomolgus monkeys (macaca fascicularis) for 14 days either before (male monkeys) or before and after (female monkeys) cohabitation with untreated mates. atgam treatment was not associated with male or female hormonal or copulation behavior changes. a decrease in fertility index in female monkeys receiving atgam was seen. female toxicity, including death, was observed with atgam doses of ≥20 mg/kg/day. while the etiology of this toxicity is uncertain, it may be attributed to hemolytic anemia due to cross-reactivity of atgam to a monkey red blood antigen. experience with children has been limited. atgam has been administered safely to a small number of pediatric renal allograft recipients and pediatric aplastic anemia patients at dosage levels comparable to those in adults. clinical experience in a limited number of elderly patients (≥65 years of age) has not identified differences in responses between the elderly and younger patients. select the dose for an elderly patient with caution, starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of comorbidities or other drug therapy in this age group.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

plasma & vaccine laboratories pty ltd - equine gamma globulins - immunotherapy - horse foal - not applicable (vet)

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - antithymocyte immunoglobulin 25mg (rabbit) - powder for infusion - 25 mg - active: antithymocyte immunoglobulin 25mg (rabbit) excipient: glycine mannitol sodium chloride - thymoglobuline® (rabbit anti - human thymocyte immunoglobulin) is indicated for the prophylaxis of graft rejection in renal transplantation; treatment of steroid - resistant or moderate to severe renal transplant rejection and in the prophylaxis of graft rejection in heart transplantation.

Canada - English - Health Canada

pfizer canada ulc - lymphocyte immunoglobulin anti-thymocyte globulin (equine) - solution - 50mg - lymphocyte immunoglobulin anti-thymocyte globulin (equine) 50mg - miscellaneous therapeutic agents

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - horse gamma globulin - injection - 50 mg/ml - horse gamma globulin 50 mg/ml

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - equine rotavirus (inactivated); apramycin; amphotericin b; neomycin; thiomersal - misc. vaccines or anti sera - equine rotavirus (inactivated) biological active 1.0 rp; apramycin antibiotic other 0.0 p; amphotericin b antibiotic other 0.0 p; neomycin antibiotic other 0.0 p; thiomersal mercury other 0.1 % - immunotherapy - horse pregnant - rotavirus enteritis | vaccine | equine rotavirus