Australien - Englisch - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - live aroa-gene deleted escherichia coli,type o78,ec34195 - misc. vaccines or anti sera - live aroa-gene deleted escherichia coli,type o78,ec34195 vaccine-microbial active 0.0 u - immunotherapy

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

energique, inc. - escherichia coli (unii: 514b9k0l10) (escherichia coli - unii:514b9k0l10) - escherichia coli 30 [hp_c] in 1 ml - may temporarily relieve diarrhea and nausea.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. may temporarily relieve diarrhea and nausea.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

genentech, inc. - polatuzumab vedotin (unii: kg6vo684z6) (polatuzumab vedotin - unii:kg6vo684z6) - polivy in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients who have previously untreated diffuse large b-cell lymphoma (dlbcl), not otherwise specified (nos) or high-grade b-cell lymphoma (hgbl) and who have an international prognostic index score of 2 or greater. polivy in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory dlbcl, nos, after at least two prior therapies. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , polivy can cause fetal harm. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of the small molecule component of polivy, mmae, to pregnant rats during organogenesis at exposures below the clinical exposure at the recommended dose of 1.8 mg/kg polivy every 21 days resulted in embryo-fetal mortality and structural abnormalities (see data) . advise a pregnant woman of the potential risks to a 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 outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data no embryo-fetal development studies in animals have been performed with polatuzumab vedotin-piiq. in an embryo-fetal developmental study in pregnant rats, administration of two intravenous doses of mmae, the small molecule component of polivy, on gestational days 6 and 13 caused embryo-fetal mortality and structural abnormalities, including protruding tongue, malrotated limbs, gastroschisis, and agnathia compared to controls at a dose of 0.2 mg/kg (approximately 0.5-fold the human area under the curve [auc] at the recommended dose). risk summary there is no information regarding the presence of polatuzumab vedotin-piiq in human milk, the effects on the breastfed child, or milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with polivy and for 2 months after the last dose. polivy can cause embryo-fetal harm when administered to pregnant women [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating polivy [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment with polivy and for 3 months after the last dose [see nonclinical toxicology (13.1)] . males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with polivy and for 5 months after the final dose [see nonclinical toxicity (13.1)] . infertility females based on findings in animal studies with mmae-containing antibody-drug conjugates (adcs), polivy may impair female fertility. the effect on fertility is reversible [see nonclinical toxicology (13.1)] . males based on findings from animal studies, polivy may impair male fertility. the reversibility of this effect is unknown [see nonclinical toxicology (13.1)] . safety and effectiveness of polivy have not been established in pediatric patients. among 435 patients treated with polivy plus r-chp in polarix, 227 (52%) were ≥65 years of age. no overall differences in safety or efficacy were observed between patients aged ≥65 years and younger patients. among 173 patients treated with polivy plus br in study go29365, 95 (55%) were ≥65 years of age. patients aged ≥65 had a numerically higher incidence of serious adverse reactions (64%) than patients aged <65 (53%). this study did not include sufficient numbers of patients to determine whether efficacy differed in patients aged ≥65 and younger patients. avoid the administration of polivy in patients with moderate or severe hepatic impairment (total bilirubin greater than 1.5 × uln and any ast). patients with moderate or severe hepatic impairment are likely to have increased exposure to mmae, which may increase the risk of adverse reactions. polivy has not been studied in patients with moderate or severe hepatic impairment [see clinical pharmacology (12.3) and warnings and precautions (5.7)]. no adjustment in the starting dose is required when administering polivy to patients with mild hepatic impairment (total bilirubin 1 to 1.5 × uln or ast greater than uln).

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

alexion pharmaceuticals australasia pty ltd - eculizumab, quantity: 300 mg - injection, intravenous infusion - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - soliris is indicated for the treatment of patients with: ? paroxysmal nocturnal haemoglobinuria (pnh) to reduce haemolysis. ? atypical haemolytic uraemic syndrome (ahus). ? adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin-4 (aqp4) antibody-positive. soliris is not intended for acute treatment of a nmosd relapse.

Israel - Englisch - Ministry of Health

alexion pharma israel ltd - eculizumab - concentrate for solution for infusion - eculizumab 10 mg/ml - eculizumab - eculizumab - soliris is indicated for the treatment of patients with: - paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. eculizumab has not been studied in clinical trials in patients with pnh below 11 years of age.- atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of: - refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive.-neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease who have received prior therapy.

Europäische Union - Englisch - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuria, paroxysmal - immunosuppressants - soliris is indicated in adults and children for the treatment of:paroxysmal nocturnal haemoglobinuria (pnh).evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of:refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive (see section 5.1).neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease.

Neuseeland - Englisch - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - insulin glargine 3.6378 mg/ml (100 iu/ml); lixisenatide 0.033 mg/ml - solution for injection - active: insulin glargine 3.6378 mg/ml (100 iu/ml) lixisenatide 0.033 mg/ml excipient: glycerol hydrochloric acid metacresol methionine sodium hydroxide water for injection zinc chloride - soliqua solostar is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

Neuseeland - Englisch - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - insulin glargine 3.6378 mg/ml (100 iu/ml); lixisenatide 0.05 mg/ml - solution for injection - active: insulin glargine 3.6378 mg/ml (100 iu/ml) lixisenatide 0.05 mg/ml excipient: glycerol hydrochloric acid metacresol methionine sodium hydroxide water for injection zinc chloride - soliqua solostar is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

Europäische Union - Englisch - EMA (European Medicines Agency)

roche registration gmbh - polatuzumab vedotin - lymphoma, b-cell - antineoplastic agents - polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large b-cell lymphoma (dlbcl) who are not candidates for haematopoietic stem cell transplant.polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (r-chp) is indicated for the treatment of adult patients with previously untreated diffuse large b-cell lymphoma (dlbcl).

Israel - Englisch - Ministry of Health

truemed ltd, israel - pitolisant as hydrochloride - film coated tablets - pitolisant as hydrochloride 17.8 mg - pitolisant - wakix is indicated• in adults for the treatment of narcolepsy with or without cataplexy. • to improve wakefulness and reduce excessive daytime sleepiness (eds) in adult patients with obstructive sleep apnoea (osa) whose eds has not been satisfactorily treated by, or who have not tolerated, osa primary therapy, such as continuous positive airway pressure (cpap).