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

rebel distributors corp - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - aviane is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the % of women continuing method typical use † perfect use ‡ levonorgestrel in a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. this represents an overall pregnancy rate of 0.84 per 100 woman-years. this rate includes patients who did not take the drug correctly. one or more pills were missed during 1,479 (18.8%) of t

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

proficient rx lp - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - aviane (levonorgestrel and ethinyl estradiol tablets usp) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization, the iud, and norplant® system, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. % of women experiencing an unintended pregnancy within the first year of use % of women continuing use at one year * method (1) typical use † (2) perfect use ‡ (3) (4) chance § 85 85 spermicides ¶ 26 6 40 periodic abstinence 25 63 calendar 9 ovulation method 3 sympto-thermal # 2 post-ovulation 1 capÞ parous women 40 26 42 nulliparous women 20 9 56 sponge parous women 40 20 42 nulliparous women 20 9 56 diaphragm Þ 20 6 56 withdrawal 19 4

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

biomarin pharmaceutical inc. - valoctocogene roxaparvovec (unii: 681k1jdi8m) (valoctocogene roxaparvovec - unii:681k1jdi8m) - roctavian is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia a (congenital factor viii deficiency with factor viii activity < 1 iu/dl) without antibodies to adeno-associated virus serotype 5 (aav5) detected by an fda-approved test. administration of roctavian is contraindicated in: - patients with active infections, either acute (such as acute respiratory infections or acute hepatitis) or uncontrolled chronic (such as chronic active hepatitis b). - patients with known significant hepatic fibrosis (stage 3 or 4 on the batts-ludwig scale or equivalent), or cirrhosis [see dosage and administration (2)]. - patients with known hypersensitivity to mannitol. risk summary roctavian is not intended for administration in women. there are no data on the use of roctavian in pregnant women to inform a drug-associated risk of adverse developmental outcome. animal reproduction and developmental toxicity studies have not been conducted with roctavian. it is not known whether roctavian can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects occurs in 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies. risk summary roctavian is not intended for administration in women. there is no information regarding the presence of roctavian in human milk, the effects on the breastfed infant, or the effects on milk production. roctavian is not intended for administration in women. contraception after administration to males in clinical studies, after administration of roctavian, transgene dna was detectable in semen [see clinical pharmacology (12.3)] . in nonclinical studies in healthy mice, the vector dna was detected in the testes for at least 182 days post-administration of roctavian at a dose level of 2.1 × 1014 vg/kg [see clinical pharmacology (12.3)]. in a mating study in immune-deficient mice, roctavian was not detected in liver tissues of offspring of naïve females mated with dosed males [see nonclinical toxicology (13.1)]. for 6 months after administration of roctavian - men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception, and - men must not donate semen. the safety and effectiveness of roctavian in pediatric patients have not been established. a single patient ≥ 65 years of age was treated with rocatvian in clinical studies. clinical studies of roctavian did not include sufficient numbers of patients aged 65 and over to determine whether the efficacy or safety differs compared to younger patients. in clinical studies, 3 hiv infected patients have been treated with roctavian. clinical studies of roctavian did not include sufficient numbers of patients with hiv to determine whether the efficacy and safety differs compared to patients without hiv infection. a single hiv infected patient treated with roctavian developed hepatocellular injury that subsequently resolved and was attributed to concomitant administration with antiretroviral drug efavirenz [see drug interactions (7.2)] . the safety and effectiveness of roctavian in patients with prior or active factor viii inhibitors have not been established [see clinical pharmacology (12.6)] . patients with active factor viii inhibitors should not take roctavian. after administration of roctavian, patients should be monitored for the development of factor viii inhibitors by appropriate clinical observations and laboratory tests [see warnings and precautions (5.4)] . the safety and effectiveness of roctavian in patients with hepatic impairment has not been established. clinical studies excluded patients with known hepatic cirrhosis, significant fibrosis (stage 3 or 4 on the batts-ludwig scale or equivalent), current hepatitis b or c, or history of hepatic malignancy. no dose adjustments can be recommended for patients with hepatic impairment. the safety and effectiveness of roctavian in patients with renal impairment has not been established. no dose adjustments can be recommended for patients with renal impairment.

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

intervet australia pty limited - avian haemaglutinating virus - killed; formaldehyde - misc. vaccines or anti sera - avian haemaglutinating virus - killed vaccine-viral active 0.0 p; formaldehyde aldehyde other 100.0 ppm - immunotherapy - poultry | breeders | broiler | chickens | chicks | chooks | day old chicks | hatchlings | layers - avian haemagglutinating adenovirus | adenovirus | egg drop syndrome

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

sanofi pasteur inc. - yellow fever virus strain 17d-204 live antigen (unii: py4eet359t) (yellow fever virus strain 17d-204 live antigen - unii:py4eet359t) - yellow fever virus strain 17d-204 live antigen 4.74 [pfu] in 0.5 ml - yf-vax is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: while the actual risk for contracting yellow fever during travel is probably low, variability of itineraries, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. greater risk is associated with living in or traveling to areas of south america and africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone. some countries require an individual to have a valid international certificate of vaccination or prophylaxis (icvp) if the individual has been in countries either known or thought to harbor yellow fever virus. the certificate becomes valid 10 days after vaccination with yf-vax. (13) (14)

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

zoetis australia pty ltd - avian encephalomyelitis virus (i strain) - unknown - avian encephalomyelitis virus (i strain) vaccine-viral active 0.0 - active constituent

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

intervet australia pty limited - avian encephalomyelitis virus (live) - unknown - avian encephalomyelitis virus (live) vaccine-viral active 0.0 - active constituent

European Union - English - EMA (European Medicines Agency)

intervet international b.v. - cell-associated live recombinant turkey herpesvirus (strain hvp360), expressing the fusion protein of nd virus and the vp2 protein of ibd virus - avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus - chicken; embryonated chicken eggs - for active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (ibd) virus,to reduce mortality, clinical signs and lesions caused by marek’s disease (md) virus.

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - live recombinant marek’s disease virus, serotype 1, strain rn1250; live recombinant turkey herpesvirus, expressing the vp2 protein of infectious bursal disease virus, strain vhvt013-69 - immunologicals for aves, domestic fowl, avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus - chicken - for active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by marek’s disease (md) virus (including very virulent md virus), and to prevent mortality, clinical signs and lesions caused by infectious bursal disease (ibd) virus.

Philippines - English - FDA (Food And Drug Administration)

boehringer ingelheim animal health philippines, inc.; distributor: boehringer ingelheim animal health philippines, inc. - infectious bursal disease (ibd) virus , reovirus virus vaccine (vet.) - emulsion for injection (im/sc) - formulation: each 0.3 ml (dose) contains: infectious bursal disease virus (vnjo strain) ....................... 21057 ccid 50 avian arthritis reovirus (s1133 strain).. ............... 2107ccids d. la culture inlocuiva drug