Iisrael - inglise - Ministry of Health

rafa laboratories ltd - palonosetron as hydrochloride - solution for injection - palonosetron as hydrochloride 0.25 mg/vial - palonosetron - palonosetron - paloxi is indicated in adults and in paediatric patients 1 month of age and older for the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

helsinn therapeutics (u.s.), inc. - mechlorethamine (unii: 50d9xsg0vr) (mechlorethamine - unii:50d9xsg0vr) - valchlor is indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous t-cell lymphoma in patients who have received prior skin-directed therapy. the use of valchlor is contraindicated in patients with known severe hypersensitivity to mechlorethamine. hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. risk summary based on case reports in humans, findings in animal reproduction studies, its mechanism of action, and genotoxicity findings, mechlorethamine may cause fetal harm. available published case reports in pregnant women receiving intravenous mechlorethamine demonstrate that mechlorethamine can cause major birth defects when a pregnant woman is systemically exposed. in animal reproduction studies, subcutaneous administration of mechlorethamine to pregnant rats and ferrets during organogenesis resulted in embryo‐fetal mortality, alterations to growth, and structural abnormalities. based on limited available data with valchlor use in pregnant women, if valchlor is used during pregnancy or if the patient becomes pregnant while taking this drug, patient should be advised of 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 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 human data the limited available data with valchlor use in pregnant women does not show evidence of congenital malformation in newborns. cases of newborns with congenital malformations have been reported in women who received systemic mechlorethamine during pregnancy. animal data mechlorethamine caused fetal malformations in the rat and ferret when given as single subcutaneous injections of 1 mg/kg. other findings in animals included embryo lethality and growth retardation when administered as a single subcutaneous injection. risk summary there are no data on the presence of mechlorethamine or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. because of the potential for topical or systemic exposure to valchlor through exposure to the mother's skin and the potential for serious adverse reactions in the breastfed child from mechlorethamine, advise patients not to breastfeed during treatment with valchlor. contraception females advise female patients of reproductive potential to use effective contraception during treatment with valchlor. a barrier method of contraception should be used to avoid direct exposure of reproductive organs to valchlor. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with valchlor [ see nonclinical toxicology (13.1) ]. a barrier method of contraception should be used to avoid direct exposure of reproductive organs to valchlor. infertility based on animal data, mechlorethamine may impair fertility in males and females [see nonclinical toxicology (13.1) ]. the reversibility of the effect on fertility is unknown. safety and effectiveness in pediatric patients have not been established. a total of 79 patients age 65 and older (31% of the clinical trial population) were treated with either valchlor or the comparator in the clinical trial. forty-four percent (44%) of patients age 65 or older treated with valchlor achieved a cails response compared to 66% of patients below the age of 65. seventy percent (70%) of patients age 65 and older experienced cutaneous adverse reactions and 38% discontinued treatment due to adverse reactions, compared to 58% and 14% in patients below the age of 65, respectively. similar differences in discontinuation rates between age subgroups were observed in the comparator group.

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

forum health products ltd - macrogol '3350'; sodium sulfate anhydrous; sodium bicarbonate; sodium chloride; potassium chloride - powder for oral solution - 59gram ; 5.685gram ; 1.685gram ; 1.465gram ; 742.5mg

Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

helsinn birex pharmaceuticals limited - sodium chloride; potassium chloride; macrogol 3350; sodium bicarbonate; sodium sulfate anhydrous - powder for oral solution - per cent - osmotically acting laxatives; macrogol, combinations

Singapur - inglise - HSA (Health Sciences Authority)

juniper healthcare pte ltd - palonosetron hydrochloride 0.28 mg/5ml eqv palonosetron - injection, solution - 50mcg/ml - palonosetron hydrochloride 0.28 mg/5ml eqv palonosetron 50mcg/ml

Malta - inglise - Malta Medicines Authority

helsinn birex pharmaceuticals limited damastown, mulhuddart, dublin 15, ireland - potassium chloride, macrogol, sodium chloride, sodium hydrogen, carbonate, sodium sulfate, anhydrous - powder for oral solution - potassium chloride 0.7425 g macrogol 3350 59 g sodium chloride 1.465 g sodium hydrogen carbonate 1.685 g sodium sulfate anhydrous 5.685 g - drugs for constipation

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

forum health products ltd - not applicable

Singapur - inglise - HSA (Health Sciences Authority)

juniper biologics pte ltd - palonosetron hcl 0.56mg eqv to palonosetron - capsule, liquid filled - palonosetron hcl 0.56mg eqv to palonosetron 0.50mg

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

helsinn therapeutics (u.s.), inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - aloxi capsules are indicated in adults for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. aloxi is contraindicated in patients known to have hypersensitivity to palonosetron [see warnings and precautions (5.1)]. risk summary there are no available data on palonosetron hcl use in pregnant women to inform a drug-associated risk. in animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron hcl during the period of organogenesis at doses up to 921 and 1,841 times the recommended human oral dose in rats and rabbits, respectively (see data) . 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 p

Uus-Meremaa - inglise - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - palonosetron hydrochloride 50 µg/ml - solution for injection - 250µg/5ml - active: palonosetron hydrochloride 50 µg/ml excipient: citric acid monohydrate disodium edetate dihydrate hydrochloric acid mannitol sodium citrate dihydrate sodium hydroxide water for injection - aloxi is indicated for prevention of nausea and vomiting induced by cytotoxic chemotherapy.