Velká Británie - angličtina - VMD (Veterinary Medicines Directorate)

zoetis uk limited - avian pneumovirus - lyophilisate for oculonasal suspension - live viral vaccine - turkeys

Španělsko - španělština - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

merck sharp & dohme animal health, s.l. - virus de la rinotraqueitis aviar (art) vivo atenuado cepa but1#8544 - liofilizado para suspensiÓn - excipientes: medio para cultivo de celulas, caseina pancreatica (producto digestiÓn), sorbitol, gelatina hidrolizado, fosfato disodico dihidratado, fosfato potasico monobasico, fosfato disodico dihidratado, cloruro de sodio, edetato de disodio, azul patente v (e-131), agua para preparaciones inyectables - virus de la rinotraqueitis aviar - pollos de engorde, pollos de reposición

Španělsko - španělština - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

laboratorios intervet, s.a. - virus de la rinotraqueitis aviar (art) vivo atenuado cepa but1#8544 - liofilizado para suspensiÓn - excipientes: medio para cultivo de celulas, caseina pancreatica (producto digestiÓn), sorbitol, gelatina hidrolizado, hidrogenofosfato de disodio dihidrato - virus de la rinotraqueitis aviar - pollos de engorde, pollos de reposición

Španělsko - španělština - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

laboratorios hipra, s.a. - virus bronquitis infecciosa, cepa h52, virus enfermedad de gumboro (w2512), virus enfermedad de newcastle, cepa la sota, virus rinotracheitis del pavo (cepa 1062) - emulsiÓn inyectable - excipientes: aceite mineral, timerosal, polisorbato 80, sorbitan monooleato, macrogol oleato - virus de la enfermedad de newcastle / paramixovirus + virus de la bronquitis infecciosa aviar + virus de la bursitis infecciosa aviar (enfermedad de gumboro) + virus de la rinotraqueitis aviar

Spojené státy - angličtina - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - levonorgestrel 0.1 mg - aviane (levonorgestrel and ethinyl estradiol tablets) 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 2  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 3 method (1) typical use 1 (2) perfect use 2 (3) (4) chance 4 85 85 spermicides 5 26 6 40 periodic abstinence 25 63      calendar 9      ovulation method 3      sympto-thermal 6 2      post-ovulation 1 cap 7      parous women 40 26 42      nulliparous women 20 9 56 sponge      parous women 40 20 42      nulliparous women 20 9 56

Spojené státy - angličtina - 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

Spojené státy - angličtina - 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.

Spojené státy - angličtina - NLM (National Library of Medicine)

physicians total care, inc. - 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 the 7

Spojené státy - angličtina - 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

Austrálie - angličtina - 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