Īrija - angļu - HPRA (Health Products Regulatory Authority)

grünenthal ltd - fentanyl - tablet sublingual - 67 microgram - phenylpiperidine derivatives

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - caspofungin acetate, quantity: 55.5 mg (equivalent: caspofungin, qty 50 mg) - injection, powder for - excipient ingredients: sodium hydroxide; mannitol; sucrose; hydrochloric acid - caspofungin kp is indicated for:,? empirical therapy for presumed fungal infections in febrile, neutropenic patients whose fever has failed to respond to broad-spectrum antibiotics,? treatment of:,-invasive candidiasis, including candidaemia,-oesophageal candidiasis,-invasive aspergillosis in patients who are refractory to or intolerant of other therapies.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: polysorbate 80; aluminium; histidine; sodium chloride; borax; water for injections - gardasil 9 is indicated in females aged 9 to 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, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: sodium chloride; histidine; borax; aluminium; water for injections; polysorbate 80 - gardasil 9 is indicated in females aged 9 to 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, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

Kanāda - angļu - Health Canada

icu medical canada inc - dextrose; sodium chloride - solution - 33.3mg; 3mg - dextrose 33.3mg; sodium chloride 3mg - replacement preparations

Kanāda - angļu - Health Canada

wood wyant canada inc - sodium dichloroisocyanurate - tablet - 55% - sodium dichloroisocyanurate 55% - disinfectants (for agents used on object)

Kanāda - angļu - Health Canada

tyco healthcare - barium sulfate - paste - 55% - barium sulfate 55% - roentgenography

Kanāda - angļu - Health Canada

nu skin international, inc. - triclosan - gel - .55% - triclosan .55% - miscellaneous local anti-infectives

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

b. braun medical inc. - lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), alanine (unii: of5 - lysine 1.18 g in 100 ml - plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. this use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: —   gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; —   bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; —   tube feeding methods alone cannot provide adequate nutrition. this solution should not be used in patients in hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization or hypersensitivity to one or more amino acids.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. 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. there is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.