Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

servier pharmaceuticals llc - calaspargase pegol (unii: t9fvh03hmz) (calaspargase pegol - unii:t9fvh03hmz) - asparlas is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 years. asparlas is contraindicated in patients with: - history of serious hypersensitivity reactions, including anaphylaxis, to pegylated l-asparaginase therapy [see warnings and precautions (5.1)] - history of serious pancreatitis during previous l-asparaginase therapy [see warnings and precautions (5.2)] - history of serious thrombosis during previous l-asparaginase therapy [see warnings and precautions (5.3)] - history of serious hemorrhagic events during previous l-asparaginase therapy [see warnings and precautions (5.4)] - severe hepatic impairment [see warnings and precautions (5.5)] risk summary based on published literature studies with l-asparaginase in pregnant animals, asparlas can cause fetal harm when administered to a pregnant woman. there are no available data on asparlas use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, intravenous administration of calaspargase pegol-mknl to pregnant rats during organogenesis at doses 0.2 to 1 times the maximum recommended human doses did not result in adverse developmental outcomes. published literature studies in pregnant rabbits, however, suggest asparagine depletion may cause harm to the animal offspring (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 are 2 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal development study, calaspargase pegol-mknl was administered intravenously at doses of 75, 150, and 300 u/kg (0.2, 0.6 and 1 times the maximum recommended human dose, respectively, based on auc) to pregnant rats during the period of organogenesis. maternal toxicity of decreased body weight and food consumption was seen at all dose levels resulting in reductions in gravid uterine and placental weights, and slight reductions in fetal body weights. no evidence of structural abnormalities or embryo-fetal mortality were observed in this study at any of the doses tested. published literature studies in which pregnant rabbits were administered l-asparaginase suggested harm to the animal offspring. risk summary there are no data on the presence of calaspargase pegol-mknl in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with asparlas and for 3 months after the last dose. asparlas can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing pregnancy testing is recommended in females of reproductive potential prior to initiating asparlas. contraception advise females of reproductive potential to use effective non-hormonal contraceptive methods during treatment with asparlas and for at least 3 months after the last dose. the safety and effectiveness of asparlas in the treatment of all have been established in pediatric patients 1 month to <17 years (no data for the age group <1 month old). use of asparlas in these age groups is supported by evidence from an adequate and well-controlled trial with additional safety from a second trial. the trials included 208 children with all or lymphoblastic lymphoma treated with asparlas; there were 19 infants (1 month to <2 years old), 128 children (2 years to <12 years old), and 61 adolescents (12 years to <17 years old). there were no clinically meaningful differences in safety or nadir serum asparaginase activity across age groups [see adverse reactions (6.1), clinical studies (14)] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

shoreline pharmaceuticals, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

avanos medical australia pty ltd - 35041 - adaptor, cable, electrosurgical unit - the cable provides a path for delivery of radiofrequency (rf) energy and temperature signals from the radiofrequency generator to the radiofrequency pain management probes to create rf lesions in nervous tissue.

Նամիբիա - անգլերեն - Namibia Medicines Regulatory Council

adcock ingram ltd - pheniramine maleate , benzocaine , calamine , phenol - cream - each 10 g cream contains: pheniramine maleate 10,2 mg, benzocaine 279,4 mg, calamine 1,22 g, phenol 25,3 mg

Բանգլադեշ - անգլերեն - DGDA (Directorate General of Drug Administration)

rasna pharmaceuticals (unani) - habb-e musaffi - tablet

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

chee sang dental supply pte ltd - dental - intended to be used by dentists for irrigation of root canal

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

derma care research labs, llc - pramoxine hydrochloride (unii: 88ayb867l5) (pramoxine - unii:068x84e056), zinc acetate (unii: fm5526k07a) (zinc cation - unii:13s1s8sf37) - topical analgesic, skin protectant for the temporary relief of pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, and rashes due to poison ivy, oak, and sumac. dries the oozing and weeping of poison ivy, oak, and sumac.

Սինգապուր - անգլերեն - HSA (Health Sciences Authority)

chee sang dental supply pte ltd - dental - ready to use temporary dental close-up material (temporary cement).

Պանամա - անգլերեն - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

laboratorios synthesis s.a.s. - extracto de insaponificables aceites de aguacate y soya (1: 2) (persea gratissima fruto 100mg y glicina max, granos 200mg) - extracto de insaponificables aceites de aguacate y soya (1: 2) (persea gratissima fruto 100mg y glicina max, granos 200mg)....300.000mg

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

clc medical pty ltd -