DUVAXYN R EQUINE ROTAVIRUS VACCINE (INACTIVATED) Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

duvaxyn r equine rotavirus vaccine (inactivated)

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

EQUIPLAS EQUINE GAMMA GLOBULINS Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

equiplas equine gamma globulins

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

ATGAM- equine thymocyte immune globulin injection, solution United States - English - NLM (National Library of Medicine)

atgam- equine thymocyte immune globulin injection, solution

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.

Equine Herpes Virus 4 (EHV-4) 405/76STRAIN Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

equine herpes virus 4 (ehv-4) 405/76strain

zoetis australia pty ltd - equine herpes virus 4 (ehv-4) 405/76 strain - unknown - equine herpes virus 4 (ehv-4) 405/76 strain vaccine active 0.0 - active constituent

EQUINE HERPES VIRUS 1 (EHV-1) 438/77STRAIN Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

equine herpes virus 1 (ehv-1) 438/77strain

zoetis australia pty ltd - equine herpes virus 1 (ehv-1) 438/77 strain - unknown - equine herpes virus 1 (ehv-1) 438/77 strain vaccine active 0.0 - active constituent

Hypermune-Equine Plasma United Kingdom - English - VMD (Veterinary Medicines Directorate)

hypermune-equine plasma

veterinary immunogenics ltd - equine plasma - solution for infusion - serum - horses

HYPERMUNE-RE EQUINE PLASMA Ireland - English - HPRA (Health Products Regulatory Authority)

hypermune-re equine plasma

veterinary immunogenics ltd - equine igg, equine total protein, antibodies to rhodococcus equi standard - intravenous inf solution - unknown - antisera, immunoglobulin preparations, and antitoxins - equine - food - immunological

DUVAXYN EHV 1,4 INACTIVATED ADJUVANTED EQUINE HERPES VACCINE Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

duvaxyn ehv 1,4 inactivated adjuvanted equine herpes vaccine

zoetis australia pty ltd - equine herpes virus 1 (ehv-1) 438/77 strain; equine herpes virus 4 (ehv-4) 405/76 strain - parenteral liquid/solution/suspension - equine herpes virus 1 (ehv-1) 438/77 strain vaccine active 0.0 p; equine herpes virus 4 (ehv-4) 405/76 strain vaccine active 0.0 p - immunotherapy - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - antibiotic - anti-infective | abrasions | abscesses | airsacculitis | antiseptic | avian mycoplasmas | blackhead | body odours | bowed tendons | broad spectrum | burns | coccidiosis | coliform complex | conjunctivitis | cowpox | cracks | crusts | dandruff | dermatological disorders | dermatosis | dry skin | dysentery | eczema | endometritis | enteric diseases | enzootic pneumonia | feed efficiency | fungal infections | girth galls | infections | inflammed pads | itching | keratolytic | lacerations | mastitis | mycoplasmas | odours | open wounds | otitis | pruritis | queensland itch | respiratory disease | saddle rash | salmonellosis | scabs | scaly skin | sheath rot | skin irritations | sores | swine dysentery | teat cracking | teat infections | topical infections | udder sores | weight gain | wire cuts | wounds