RAK 1+2 FORTE Italia - italiensk - Ministero della Salute

rak 1+2 forte

basf italia s.p.a. - (e,e/z)-7,9-dodecadienilacetato; (e,e)-7,9-dodecadien-1-yl acetate; - prodotto con s.a. evaporabile - 217.0 mg; 226.0 mg i valori indicati sono per 100 g di prodotto. - feromone

Anterone 100 cyproterone acetate 100mg tablet blister pack Australia - engelsk - Department of Health (Therapeutic Goods Administration)

anterone 100 cyproterone acetate 100mg tablet blister pack

cipla australia pty ltd - cyproterone acetate, quantity: 100 mg - tablet, uncoated - excipient ingredients: colloidal anhydrous silica; maize starch; pregelatinised maize starch; lactose monohydrate; magnesium stearate; povidone - inoperable prostatic carcinoma. to suppress 'flare' with initial luteinising hormone releasing hormone (lhrh) analogue therapy; in long-term palliative treatment where lhrh analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with lhrh analogues or who have had orchidectomy.

COLIFOAM (10% w/w Hydrocortisone Acetate) Rectal Foam Cream aerosol can Australia - engelsk - Department of Health (Therapeutic Goods Administration)

colifoam (10% w/w hydrocortisone acetate) rectal foam cream aerosol can

viatris pty ltd - hydrocortisone acetate, quantity: 10 % w/w - enema - excipient ingredients: cetyl alcohol; emulsifying wax; methyl hydroxybenzoate; propyl hydroxybenzoate; steareth-10; propylene glycol; trolamine; purified water; propane; isobutane - this product approved for registraiton as a variation of a product accepted for inclusion in the artg as 'currently supplied' at the commencement of the act. indications are held in artg paper records. previous product number aust r 15654. product information not reviewed. indications as at 21 august 1998: topical treatment of inflammation occurring in the rectal mucosa, eg ulcerative colitis, proctosigmoiditis and granular proctitis.

APO-ABIRATERONE ACETATE FILM COATED TABLETS Comprimé Canada - fransk - Health Canada

apo-abiraterone acetate film coated tablets comprimé

apotex inc - acétate d'abiratérone - comprimé - 500mg - acétate d'abiratérone 500mg - antineoplastic agents

ABIRATERONE ACETATE tablet USA - engelsk - NLM (National Library of Medicine)

abiraterone acetate tablet

apotex corp. - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with - metastatic castration-resistant prostate cancer (crpc) - metastatic high-risk castration-sensitive prostate cancer (cspc) none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy.   there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data).   data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6 to 17). findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. doses ≥10 mg/kg/day caused maternal toxicity. the doses tested in rats resulted in systemic exposures (auc) approximately 0.03, 0.1 and 0.3 times, respectively, the auc in patients. risk summary the safety and efficacy of abiraterone acetate have not been established in females. there is no information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production. contraception males based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate [see use in specific populations (8.1)] .   infertility based on animal studies, abiraterone acetate may impair reproductive function and fertility in males of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of abiraterone acetate in pediatric patients have not been established. of the total number of patients receiving abiraterone acetate in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. no overall differences in safety or effectiveness were observed between these elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (child-pugh class a and b, respectively) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone after a single oral 1,000 mg dose of abiraterone acetate increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. in another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (n=8) hepatic impairment (child-pugh class c) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function. no dosage adjustment is necessary for patients with baseline mild hepatic impairment. in patients with baseline moderate hepatic impairment (child-pugh class b), reduce the recommended dose of abiraterone acetate  to 250 mg once daily. do not use abiraterone acetate in patients with baseline severe hepatic impairment (child-pugh class c). if elevations in alt or ast >5 x uln or total bilirubin >3 x uln occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate treatment [see dosage and administration (2.4) and clinical pharmacology (12.3)] . for patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see dosage and administration (2.4), warnings and precautions (5.3), and clinical pharmacology (12.3)] . no dosage adjustment is necessary for patients with renal impairment [see clinical pharmacology (12.3)].

ABIRATERONE ACETATE tablet USA - engelsk - NLM (National Library of Medicine)

abiraterone acetate tablet

major pharmaceuticals - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy.   there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data).   data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6 to 17). findings included embryo-fetal lethality (increased post implantation loss and r

FLUDROCORTISONE MEDSURGE fludrocortisone acetate 100 microgram tablet blister Australia - engelsk - Department of Health (Therapeutic Goods Administration)

fludrocortisone medsurge fludrocortisone acetate 100 microgram tablet blister

medsurge pharma pty ltd - fludrocortisone acetate, quantity: 100 microgram - tablet - excipient ingredients: colloidal anhydrous silica; magnesium stearate; hypromellose; mannitol; microcrystalline cellulose; croscarmellose sodium - partial replacement therapy for primary adrenocortical insufficiency in addison's disease and for the treatment of salt losing adrenogenital syndrome.

YL Selenium Zinc Plus Capsule Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

yl selenium zinc plus capsule

yanling natural hygiene sdn. bhd. - betacarotene; d-alpha tocopheryl acetate; pyridoxine hydrochloride; ascorbic acid (vitamin c); selenium yeast; zinc yeast -

YL ENerv Capsule Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

yl enerv capsule

yanling natural hygiene sdn. bhd. - methylcobalamin; alpha lipoic acid; d-alpha tocopheryl acetate; benfotiamine; pyridoxine hydrochloride -