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

dr reddys laboratories australia pty ltd - capecitabine, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; hypromellose; magnesium stearate; lactose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red - colon cancer ,capecitabine is indicated for the adjuvant treatment of patients with dukes? stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated ,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

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

dr reddys laboratories australia pty ltd - capecitabine, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose; magnesium stearate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; iron oxide yellow; iron oxide red - colon cancer ,capecitabine is indicated for the adjuvant treatment of patients with dukes? stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated ,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

USA - engelsk - NLM (National Library of Medicine)

terrain pharmaceuticals - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), camphor (natural) (unii: n20hl7q941) (camphor (natural) - unii:n20hl7q941), methyl salicylate (unii: lav5u5022y) (salicylic acid - unii:o414pz4lpz) - lidocaine 2.5 mg in 100 mg - topical analgesic topical anesthetic topical analgesic temporarily relieves mild to moderate aches and pains of muscles and joints associated with: • muscle soreness • strains • sprains • arthritis • simple backache • muscle stiffness • bruises • clean and dry affected area • open pouch and remove one patch • remove protective film from patch • apply one patch to the affected area of pain and leave in place for 8 to 12 hours • if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • only use one patch at a time • do not use more than 2 patches per day • wash hands with soap and water after applying or removing patch • reseal pouch containing unused patches immediately after each use children under 12 years of age: do not use

USA - engelsk - NLM (National Library of Medicine)

trigen laboratories, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole is indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (includi

USA - engelsk - NLM (National Library of Medicine)

trigen laboratories, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 10 mg - aripiprazole orally disintegrating tablets, usp are indicated for the treatment of: •schizophrenia [see clinical studies (14.1)] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information.  aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)]. teratogenic effects pregnancy category c: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary   neonates exposed

USA - engelsk - NLM (National Library of Medicine)

puracap laboratories llc dba blu pharmaceuticals - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 500 mg - ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by escherichia coli , klebsiella pneumoniae , enterobacter cloacae , serratia marcescens , proteus mirabilis , providencia rettgeri , morganella morganii , citrobacter koseri , citrobacter freundii , pseudomonas aeruginosa , methicillin-susceptible staphylococcus epidermidis , staphylococcus saprophyticus , or enterococcus faecalis . ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus. ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis. ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by esche

USA - engelsk - NLM (National Library of Medicine)

prasco laboratories - mefenamic acid (unii: 367589pj2c) (mefenamic acid - unii:367589pj2c) - mefenamic acid 250 mg - carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ;   g astrointestinal  bleeding, ulceration, and perforation ). mefenamic acid is indicated: - for relief of mild to moderate pain in patients ≥ 14 years of age, when therapy will not exceed one week (7 days). - for treatment of primary dysmenorrhea. mefenamic acid is contraindicated in the following patients. - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid or any components of the drug product (see warnings ;  anaphylactic reactions , serious skin reactions ). - history of asthma, urticarial, or other allergic-type reactions after taking aspirin or other nsaids.  severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients (see warnings;    anaphylactic reaction,

USA - engelsk - NLM (National Library of Medicine)

bluepoint laboratories - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 25 mg - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets, usp and other treatment options before deciding to use diclofenac sodium delayed-release tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diclofenac sodium delayed-release tablets, usp, are indicated: diclofenac sodium delayed-release tablets, are contraindicated in patients with known hypersensitivity to diclofenac. diclofenac sodium delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings: anaphylactic reactions and precautions: preexisting asthma ). diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

USA - engelsk - NLM (National Library of Medicine)

upsher-smith laboratories, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 400 mg - because of its life-threatening side effects and the substantial management difficulties associated with its use (see warnings below), pacerone® (amiodarone hydrochloride) tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. - recurrent ventricular fibrillation. - recurrent hemodynamically unstable ventricular tachycardia. as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hydrochloride tablets favorably affects survival. pacerone® (amiodarone hydrochloride) tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, includin

USA - engelsk - NLM (National Library of Medicine)

ohm laboratories inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate tablets, usp are indicated for the suppressive treatment and treatment of acute attacks of malaria due to plasmodium vivax , p. malariae , p. ovale , and susceptible strains of p. falciparum . hydroxychloroquine sulfate tablets, usp are also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.