Malta - English - Medicines Authority

roche products limited 6 falcon way, shire park, welwyn garden city, al7 1tw, united kingdom - benserazide, levodopa - prolonged-release capsule - benserazide 25 mg levodopa 100 mg - anti-parkinson drugs

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

baxter healthcare corporation - valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), alanine (unii: of5p57n2zx) (alanine - unii:of5p57n2zx), glycine (unii: te7660xo1c) (glycine - unii:te7660xo1c), arginine (unii: 94zla3w45f) (arginine - unii:94zla3w45f), proline (unii: 9dlq4ciu6v) (proline - unii:9dlq4ciu6v), glutamic acid (unii: 3kx376gy7l) (glutamic acid - unii:3kx376gy7l), serine (unii: 452vly9402) (serine - unii:452vly9402), aspartic acid (unii: 30kyc7miai) (aspartic acid - unii:30kyc7miai), tyrosine (unii: 42hk56048u) (tyrosine - unii:42hk56048u) - valine 1.44 g in 100 ml - prosol is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. prosol may be used to treat negative nitrogen balance in patients. the use of prosol is contraindicated in: risk summary limited published data with injectable amino acids solutions, including prosol in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. however, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see clinical considerations]. animal reproduction studies have not been conducted with injectable amino acids solutions, including prosol. the 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. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. clinical considerations disease-associated maternal and/or embryo-fetal risk severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary there are no data available to assess the presence of injectable amino acids, including prosol in human milk, the effects of prosol on the breastfed infant or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of prosol to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prosol and any potential adverse effects on the breastfed child from prosol or from the underlying maternal condition. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see dosage and administration (2.7)]. plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. hyperammonemia is of special significance in infants (birth to two years). this reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. it is essential that blood ammonia be measured frequently in infants [see warnings and precautions (5.7)]. because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with prosol may be at risk of aluminum toxicity [see warnings and precautions (5.8)]. patients, including pediatric patients, may be at risk for pnald [see warnings and precautions (5.9)]. clinical studies with prosol have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. in patients with impaired renal function, parenteral nutrition solutions containing prosol should be administered with caution. frequent clinical evaluation and laboratory tests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see dosage and administration (2.6) , and warnings and precautions (5.10)]. in patients with impaired liver function, parenteral nutrition solutions containing prosol should be administered starting at the low end of the dosing range [see dosage and administration (2.5)]. frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted [see warnings and precautions (5.7) ].

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

takeda pharmaceuticals america, inc. - protein c (unii: 3z6s89txpw) (protein c - unii:3z6s89txpw) - protein c 500 [iu] in 5 ml - ceprotin, protein c concentrate (human), is an anticoagulant indicated for neonates, pediatric and adult patients with severe congenital protein c deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. none. risk summary there are no data with ceprotin use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with ceprotin. it is also not known whether ceprotin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ceprotin has not been studied for use during labor and delivery. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively, regardless of drug exposure. risk summary there is no information regarding the presence of ceprotin in human milk, the effect on the breastfed infant, or the effects on milk production. ceprotin has not been studied for use in nursing mothers

Malta - English - Medicines Authority

rontis hellas medical and pharmaceutical products s.a. 38, sorou str., athens, maroussi, 15125, greece - fampridine - prolonged-release tablet - fampridine 10 mg - other nervous system drugs

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - denosumab, quantity: 60 mg/ml - injection, solution - excipient ingredients: acetate; water for injections; polysorbate 20; sodium hydroxide; sorbitol - the treatment of osteoporosis in postmenopausal women. prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.,treatment to increase bone mass in men with osteopaenia receiving androgen deprivation therapy for non-metastatic prostate cancer (see clinical trials).,treatment to increase bone mass in men with osteoporosis at increased risk of fracture.,treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

proterra pty ltd - ethephon - soluble concentrate - ethephon organophosphorus active 720.0 g/l - growth regulator - cotton - acceleration of boll opening | defoliation of cotton plants | pre-conditioning prior to defoliation | before normal defoliation is t | defoliation aid

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

tap pharmaceutical products inc. - leuprolide acetate (unii: 37jns02e7v) (leuprolide - unii:efy6w0m8tg) - kit - 5 mg in 1 ml - lupron injection (leuprolide acetate) is indicated in the palliative treatment of advanced prostatic cancer. - lupron injection is contraindicated in patients known to be hypersensitive to gnrh, gnrh agonist analogs or any of the excipients in lupron injection: reports of anaphylactic reactions to gnrh agonist analogs have been reported in the medical literature.1,2 - lupron is contraindicated in women who are or may become pregnant while receiving the drug. lupron may cause fetal harm when administered to a pregnant woman. therefore, the possibility exists that spontaneous abortion may occur if the drug is administered during pregnancy. if this drug is administered during pregnancy or if the patient becomes pregnant while taking any formulation of lupron, the patient should be apprised of the potential hazard to the fetus. lupron® injection (leuprolide acetate) rx only lupron injection is indicated in the treatment of children with central precocious puberty. children should be selected using the follow

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

amgrow pty ltd - tau-fluvalinate; myclobutanil - suspension concentrate - tau-fluvalinate pyrethroid active 9.6 g/l; myclobutanil triazole active 4.4 g/l - mixed function pesticide - ornamental | rose | carnation | chrysanthemum | indoor foliage plant | rose | sturt's desert rose - aphid | black spot | helicoverpa spp. | native budworm or bollworm | powdery mildew | rust | thrip | two spotted mite | whitefly | corn earworm | cotton bollworm | heliothis | native bollworm | native budworm | red spider mite | scab | spider mite | thrips spp. | tobacco budworm | tomato grub | two-spotted mite | two-spotted spider mite

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

adama australia pty limited - tau-fluvalinate; ethylene glycol - suspension concentrate - tau-fluvalinate pyrethroid active 240.0 g/l; ethylene glycol solvent other 94.0 g/l - insecticide - apple | asparagus | cauliflower | cherry | flowering plants | grape - table | nectarine | ornamental | peach | plum | shrub | to - apple dimpling bug - c. liebknechti | cabbage moth | cabbage white butterfly | carmine mite | corn earworm | garden or south african vine weevil | green peach aphid | helicoverpa spp. | native budworm or bollworm | plague thrips | tomato grub | campylomma livida | corn earworm | cotton bollworm | diamondback moth | garden weevil | heliothis | native bollworm | native budworm | red spider mite | south african vine weevil | spider mite | tobacco budworm | tomato grub | two-spotted mite | two-spotted spider mite | yellow mirid

Australia - English - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 20 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 40 microgram; hpv type 18 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: aluminium; histidine; polysorbate 80; borax; water for injections; sodium chloride - gardasil is indicated in females aged 9 through 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, and 18 (which are included in the vaccine). gardasil is indicated in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by hpv types 6, 11, 16, and 18 (which are included in the vaccine). *immunogenicity studies have been conducted to link efficacy in females and males aged 16 to 26 years to the younger populations.