APO-ATOMOXETINE atomoxetine (as hydrochloride) 10 mg capsule blister Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

apo-atomoxetine atomoxetine (as hydrochloride) 10 mg capsule blister

arrotex pharmaceuticals pty ltd - atomoxetine hydrochloride, quantity: 11.4 mg (equivalent: atomoxetine, qty 10 mg) - capsule, hard - excipient ingredients: gelatin; titanium dioxide; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - for the treatment of attention deficit hyperactivity disorder (adhd) as defined by dsm-iv criteria in children 6 years of age and older, adolescents and adults.

BALVERSA- erdafitinib tablet, film coated Spojené štáty - angličtina - NLM (National Library of Medicine)

balversa- erdafitinib tablet, film coated

janssen products lp - erdafitinib (unii: 890e37nhmv) (erdafitinib - unii:890e37nhmv) - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc) with susceptible fgfr3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. select patients for therapy based on an fda-approved companion diagnostic for balversa [see dosage and administration (2.1)and clinical studies (14.1)] . limitations of use balversa is not recommended for the treatment of patients who are eligible for and have not received prior pd-1 or pd-l1 inhibitor therapy [see clinical studies (14.1)] . none. risk summary based on the mechanism of action and findings in animal reproduction studies, balversa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on balversa use in pregnant women to inform a drug-associated risk. oral administration of erdafitinib to pregnant rats during organogenesis caused malformations and embryo-fetal death at maternal exposures that were less than the human exposures at the maximum recommended human dose based on auc (see data ). advise pregnant women and females of reproductive potential 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 animal data in an embryo-fetal toxicity study, erdafitinib was orally administered to pregnant rats during the period of organogenesis. doses ≥4 mg/kg/day (at total maternal exposures <0.1% of total human exposures at the maximum recommended human dose based on auc) produced embryo-fetal death, major blood vessel malformations and other vascular anomalies, limb malformations (ectrodactyly, absent or misshapen long bones), an increased incidence of skeletal anomalies in multiple bones (vertebrae, sternebrae, ribs), and decreased fetal weight. risk summary there are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the breastfed child, or on milk production. because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with balversa and for one month following the last dose. balversa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating treatment with balversa. contraception females advise females of reproductive potential to use effective contraception during treatment with balversa and for one month after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during treatment with balversa and for one month after the last dose. infertility females based on findings from animal studies, balversa may impair fertility in females of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of balversa in pediatric patients have not been established. in 4 and 13-week repeat-dose toxicology studies in rats and dogs, toxicities in bone and teeth were observed at an exposure less than the human exposure (auc) at the maximum recommended human dose. chondroid dysplasia/metaplasia were reported in multiple bones in both species, and tooth abnormalities included abnormal/irregular denting in rats and dogs and discoloration and degeneration of odontoblasts in rats. of the 479 patients treated with balversa in clinical studies, 40% of patients were less than 65 years old, 40% of patients were 65 years to 74 years old, and 20% were 75 years old and over. patients 65 years of age and older treated with balversa experienced a higher incidence of adverse reactions requiring treatment discontinuation than younger patients. in clinical trials, the incidence of treatment discontinuations of balversa due to adverse reactions was 10% in patients younger than 65 years, 20% in patients ages 65–74 years, and 35% in patients 75 years or older. no overall difference in efficacy was observed between these patients and younger patients [see clinical studies (14.1)]. cyp2c9*3/*3 genotype: erdafitinib plasma concentrations are predicted to be higher in patients with the cyp2c9*3/*3 genotype. monitor for increased adverse reactions in patients who are known or suspected to have cyp2c9*3/*3 genotype [see pharmacogenomics (12.5)] .

PEMAZYRE- pemigatinib tablet Spojené štáty - angličtina - NLM (National Library of Medicine)

pemazyre- pemigatinib tablet

incyte corporation - pemigatinib (unii: y6bx7bl23k) (pemigatinib - unii:y6bx7bl23k) - pemazyre is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or other rearrangement as detected by an fda-approved test [see dosage and administration (2.1)] . this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.1)].  continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). pemazyre is indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (mlns) with fibroblast growth factor receptor 1 (fgfr1) rearrangement. none. risk summary based on findings in an animal study and its mechanism of action, pemazyre can cause fetal harm or loss of pregnancy when administered to a pregnant woman [see clinical pharmacology ( 12.1 )] . there are no available data on the use of pemazyre in preg

CLAVUBACTIN L 625 MG BROAD SPECTRUM ANTIBIOTIC TABLETS Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

clavubactin l 625 mg broad spectrum antibiotic tablets

le vet beheer b. v. - amoxycillin (as the trihydrate); clavulanic acid as potassium clavulanate - oral tablet - amoxycillin (as the trihydrate) antibiotic active 500.0 mg/tb; clavulanic acid as potassium clavulanate antibiotic active 125.0 mg/tb - antibiotic & related - dog - large - bacterial infection | amoxycillin sensitive bacteria | associated with viral disease | gram negative organisms | gram positive organisms | post parturient bacterial infe | primary bacterial infection | sulfadiazine sensitive bacteri | trimethoprim sensitive bacteri | tylosin sensitive bacteria

CLAVUBACTIN M 312.5 MG BROAD SPECTRUM ANTIBIOTIC TABLETS Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

clavubactin m 312.5 mg broad spectrum antibiotic tablets

le vet beheer b. v. - amoxycillin (as the trihydrate); clavulanic acid as potassium clavulanate - oral tablet - amoxycillin (as the trihydrate) antibiotic active 250.0 mg/tb; clavulanic acid as potassium clavulanate antibiotic active 62.5 mg/tb - antibiotic & related - dog - medium | castrate - bacterial infection | amoxycillin sensitive bacteria | associated with viral disease | gram negative organisms | gram positive organisms | post parturient bacterial infe | primary bacterial infection | sulfadiazine sensitive bacteri | trimethoprim sensitive bacteri | tylosin sensitive bacteria

TRIMEBUTINE MALEATE Tablets 100mg "SAWAI" (トリメブチンマレイン酸塩錠100mg「サワイ」) Japonsko - angličtina - すりの適正使用協議会 RAD-AR Council, Japan

trimebutine maleate tablets 100mg "sawai" (トリメブチンマレイン酸塩錠100mg「サワイ」)

sawai pharmaceutical co.,ltd. - trimebutine maleate - white to faintly yellowish white tablet, diameter: 8.2 mm, thickness: 3.5 mm

STANNUM METALLICUM cream Spojené štáty - angličtina - NLM (National Library of Medicine)

stannum metallicum cream

true botanica, llc - tin (unii: 387gmg9fh5) (tin - unii:387gmg9fh5) - tin 6 [hp_x] in 50 ml - enter section text here for temporary relief of nerve pain and joint pains. may also be used for standard homeopathic indications or as directed by your physician. tamper evident: do not use if safety seal is broken before first use.

STANNUM 5 ointment Spojené štáty - angličtina - NLM (National Library of Medicine)

stannum 5 ointment

uriel pharmacy inc. - tin (unii: 387gmg9fh5) (tin - unii:387gmg9fh5) - tin 1 [hp_x] in 1 g - directions: for topical use only. use: temporary relief of headache.

STANNUM 5 cream Spojené štáty - angličtina - NLM (National Library of Medicine)

stannum 5 cream

uriel pharmacy inc. - tin (unii: 387gmg9fh5) (tin - unii:387gmg9fh5) - tin 5 [hp_x] in 1 g - directions: for topical use only. use: temporary relief of headache.

STANNUM 0.4 ointment Spojené štáty - angličtina - NLM (National Library of Medicine)

stannum 0.4 ointment

uriel pharmacy inc. - tin (unii: 387gmg9fh5) (tin - unii:387gmg9fh5) - tin 1 [hp_x] in 1 g - directions: for topical use only. use: temporary relief of headache.