Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

hamad town pharmacy - hedera helix (ivy leaf) dry extract - drops

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

ivy dry, inc. - benzyl alcohol 10% camphor 0.6% menthol 0.4%, external analgesic - for the temporary relief of itching associated with insect bites and minor skin irritations.

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

ivy-dry, inc. - benzyl alcohol 10%, camphor 0.5%, menthol 0.25%, external analgesic - - for the temporary relief of itching associated with insect bites and minor skin irritations

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

ivy-dry, inc. - benzyl alcohol 10%, camphor 0.5%, menthol 0.25%, , external analgesic, - - for the temporary relief of itching associated with insect bites and minor skin irritations

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

gulf pharmaceutical industries (julphar), united arab emirates - ivy - syrup - 35

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

mcneil products ltd - ethanol 30%; ivy leaf dry extract; sorbitol - oral solution - 8.25mg/1ml ; 708mg/1ml

European Union - English - EMA (European Medicines Agency)

intervet international bv - indoxacarb - ectoparasiticides for topical use, incl. insecticides, indoxacarb - dogs; cats - treatment and prevention of flea infestation.for dogs and cats: treatment and prevention of flea infestation.the veterinary medicinal product can be used as part of a treatment strategy for flea-allergy dermatitis. developing stages of fleas in the pet's immediate surroundings are killed following contact with activyl-treated pets.

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

merrimack pharmaceuticals - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 4.3 mg in 1 ml - onivyde™   is indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. limitation of use: onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas [see clinical studies (14) ] . onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to onivyde or irinotecan hcl. risk summary based on animal data with irinotecan hcl and the mechanism of action of onivyde, onivyde can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no available data in pregnant women. embryotoxicity and teratogenicity were observed following treatment with irinotecan hcl, at doses resulting in irinotecan exposures lower than those achieved with onivyde 70 mg/m2 in humans, administered to pregnant rats and rabbits during organogenesis [see data ]. a

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

ipsen biopharmaceuticals, inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 4.3 mg in 1 ml - - onivyde® is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. - onivyde® is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. limitations of use: onivyde is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. [see clinical studies (14)] . onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction or anaphylaxis to onivyde or irinotecan hcl. [see warnings and precautions (5.4), adverse reactions (6.2)]. risk summary based on animal data with irinotecan hcl and the mechanism of action of onivyde, onivyde can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women. embryotoxicity and teratogenicity were observed following treatment with irinotecan hcl, at doses resulting in irinotecan exposures lower than those achieved with onivyde 70 mg/m2 in humans, administered to pregnant rats and rabbits during organogenesis [see data] . advise pregnant women of the potential risk to a fetus. 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 animal studies have been conducted to evaluate the effect of irinotecan liposome on reproduction and fetal development; however, studies have been conducted with irinotecan hcl. irinotecan crosses the placenta of rats following intravenous administration. intravenous administration of irinotecan at a dose of 6 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses. in separate studies in rats, this dose resulted in an irinotecan exposure of approximately 0.002 times the exposure of irinotecan based on area under the curve (auc) in patients administered onivyde at the 70 mg/m2 dose. administration of irinotecan hcl resulted in structural abnormalities and growth delays in rats at doses greater than 1.2 mg/kg/day (approximately 0.0002 times the clinical exposure to irinotecan in onivyde based on auc). teratogenic effects included a variety of external, visceral, and skeletal abnormalities. irinotecan hcl administered to rat dams for the period following organogenesis through weaning at doses of 6 mg/kg/day caused decreased learning ability and decreased female body weights in the offspring. risk summary there is no information regarding the presence of irinotecan liposome, irinotecan, or sn-38 (an active metabolite of irinotecan) in human milk, or the effects on the breastfed infant or on milk production. irinotecan is present in rat milk [see data]. because of the potential for serious adverse reactions in breastfed infants from onivyde, advise a nursing woman not to breastfeed during treatment with onivyde and for one month after the last dose. data radioactivity appeared in rat milk within 5 minutes of intravenous administration of radiolabeled irinotecan hcl and was concentrated up to 65-fold at 4 hours after administration relative to plasma concentrations. contraception females onivyde 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 onivyde and for seven months after the last dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with onivyde and for four months after the last dose [see nonclinical toxicology (13.1)]. safety and effectiveness of onivyde have not been established in pediatric patients. of the 634 patients who received onivyde as a single agent, in combination with fu and leucovorin or in combination with oxaliplatin, fu and leucovorin in napoli-1 and napoli 3, 49% were ≥ 65 years old and 10% were ≥ 75 years old. no overall differences in safety and effectiveness were observed between these patients and younger patients.

United States - English - 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).