Φιλιππίνες - Αγγλικά - FDA (Food And Drug Administration)

n/a; importer: n/a; distributor: life and health source pharmaceutical distribution - methyl salicylate , camphor , menthol - liniment oil - 13.85 ml (13.85 % v/v)/3.85 g (3.85% w/v)/423 mg (0.42% w/v) per 100 ml

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 250 mg - carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen as naproxen tablets or naproxen sodium tablets are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. naproxen as naproxen tablets and naproxen sodium tablets are also indicated: - for relief of the signs and symptoms of tendonitis - for relief of the signs and symptoms of bursitis - for relief of the signs and symptoms of

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - naproxen sodium (unii: 9tn87s3a3c) (naproxen - unii:57y76r9atq) - naproxen sodium 275 mg - carefully consider the potential benefits and risks of naproxen, naproxen sodium and other treatment options before deciding to use naproxen or naproxen sodium tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). naproxen as naproxen tablets or naproxen sodium tablets are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. naproxen as naproxen tablets and naproxen sodium tablets are also indicated: - for relief of the signs and symptoms of tendonitis - for relief of the signs and symptoms of bursitis - for relief of the signs and symptoms of

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - ketoprofen (unii: 90y4qc304k) (ketoprofen - unii:90y4qc304k) - carefully consider the potential benefits and risks of ketoprofen capsules usp and other treatment options before deciding to use ketoprofen capsules usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketoprofen capsules usp are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ketoprofen capsules usp are indicated for the management of pain. ketoprofen capsules usp are also indicated for treatment of primary dysmenorrhea. ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. ketoprofen capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see warnings , anaphylactoid reactions and precautions ,

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - ketoprofen (unii: 90y4qc304k) (ketoprofen - unii:90y4qc304k) - carefully consider the potential benefits and risks of ketoprofen capsules usp and other treatment options before deciding to use ketoprofen capsules usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketoprofen capsules usp are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ketoprofen capsules usp are indicated for the management of pain. ketoprofen capsules usp are also indicated for treatment of primary dysmenorrhea. ketoprofen capsules are contraindicated in patients who have shown hypersensitivity to ketoprofen. ketoprofen capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see warnings , anaphylactoid reactions and precautions ,

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam tablets usp are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam tablets usp are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; and stiff-man syndrome. oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets usp and other treatment options before deciding to use ketorolac tromethamine tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administrati

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

medsource pharmaceuticals - flurbiprofen (unii: 5gro578klp) (flurbiprofen - unii:5gro578klp) - flurbiprofen tablets are indicated: - for relief of the signs and symptoms of rheumatoid arthritis. - for relief of the signs and symptoms of osteoarthritis. - flurbiprofen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to flurbiprofen or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ]. - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. risk summary use of nsaids, including flurbiprofen, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including flurbiprofen, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of flurbiprofen in pregnant women. data from observational studies regarding potential embryo-fetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. in animal reproduction studies, delayed parturition, prolonged labor, stillborn fetuses, and the presence of retained fetuses at necropsy occurred following treatment of pregnant rats treated with oral flurbiprofen throughout gestation until labor at less than 1-time the human dose of 300 mg/day. embryofetal lethality was seen in pregnant rats and rabbits administered oral flurbiprofen during the period of organogenesis at exposures 0.03-times and 0.5 times, respectively, the human dose of 300 mg. no evidence of malformations were noted in rats, rabbits, or mice treated with flurbiprofen during the period of organogenesis at doses that were 0.8-, 0.5-, and 0.2-times the maximum human daily dose [see data]. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as flurbiprofen, resulted in increased pre- and post-implantation loss. clinical considerations labor or delivery there are no studies on the effects of flurbiprofen during labor or delivery. in animal studies, nsaids, including flurbiprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data animal data pregnant rats were treated with oral doses of 0.05, 1, and 3 mg/kg flurbiprofen 14 days prior to mating through gestation day (gd) 16. embryofetal lethality was seen at 1 mg/kg and above (0.03 times the maximum recommended human dose [mrhd] of 300 mg on a mg/m 2 basis). no maternal toxicity was evident at this dose. no malformations were seen in fetuses from pregnant rats administered flurbiprofen during the period of organogenesis at doses up to 25 mg/kg (0.8 times the mrhd on a mg/m 2 basis). maternal toxicity (uterine hemorrhage, gastric ulcers) was observed at this dose. pregnant rabbits were administered oral doses of 0.675, 2.25, and 7.5 mg/kg flurbiprofen from gd 1 through gd 29. embryofetal lethality, but no evidence of teratogenicity, was seen at 7.5 mg/kg (0.5 times the mrhd of 300 mg on a mg/m 2 basis). maternal toxicity (gastric ulcers and lethality) was observed at this dose. pregnant mice were treated with oral doses of 2, 5, and 12 mg/kg flurbiprofen from gd 3 to 18. an increased incidence of fetal lethality occurred in the 12 mg/kg group (0.2 times the mrhd). all doses were associated with some evidence of maternal toxicity (placental hemorrhage). pregnant rats were treated with oral doses of 0.2, 0.675, 2.25, 7.5, and 25 mg/kg flurbiprofen from gd 1 until labor. delayed delivery, the incidence of stillborn pups, and decreased pup viability, were noted at doses of 2.25 mg/kg and higher (0.07 times the mrhd). these doses were associated with maternal toxicity (uterine hemorrhage, gastrointestinal ulceration, decreased body weight). pregnant rats treated with oral doses of 0.4, 4, and 10 mg/kg flurbiprofen from gd 16 to labor, delayed parturition was seen at 0.4 mg/kg and above and stillborn pups were seen at 4 mg/kg and above (0.01-times and 0.13 times, respectively, the mrhd on mg/m 2 basis). uterine hemorrhage, ulceration, and mortality were noted in dams at 0.4 mg/kg and above. risk summary flurbiprofen is poorly excreted into human milk. the nursing infant dose is predicted to be approximately 0.1 mg/day in the established milk of a woman taking flurbiprofen 200 mg/day. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for flurbiprofen and any potential adverse effects on the breastfed infant from flurbiprofen or from the underlying maternal condition. infertility females based on the mechanism of action, the use of prostaglandin-mediated nsaids, including flurbiprofen, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including flurbiprofen, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients have not been established. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see warnings and precautions ( 5.1, 5.2, 5.3, 5.6, 5.13) ].

Μαλαισία - Αγγλικά - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

life biopharma sdn. bhd. - colistin sulphate -