Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

mylan - simvastatin; fenofibrate - tablet - 20mg ; 145mg

Marekani - Kiingereza - NLM (National Library of Medicine)

lannett company, inc. - fluvastatin sodium (unii: pyf7o1fv7f) (fluvastatin - unii:4l066368as) - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. fluvastatin sodium extended-release tablets are indicated - as an adjunct to diet to reduce elevated total cholesterol (total-c), low-density lipoprotein cholesterol (ldl-c), triglyceride (tg) and apolipoprotein b (apo b) levels, and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary hypercholesterolemia and mixed dyslipidemia (fredrickson type iia and iib). - as an adjunct to diet to reduce total-c, ldl-c, and apo b levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present: ldl-c remains ≥ 190 mg/dl or ldl-c remains ≥ 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present - ldl-c remains ≥ 190 mg/dl or - ldl-c remains ≥ 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other cardiovascular disease risk factors are present - there is a positive family history of premature cardiovascular disease or - two or more other cardiovascular disease risk factors are present the ncep classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cvd is summarized below. children treated with fluvastatin in adolescence should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals. in patients with clinically evident chd, fluvastatin sodium extended-release tablets are indicated to: - reduce the risk of undergoing coronary revascularization procedures - slow the progression of coronary atherosclerosis fluvastatin sodium extended-release tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons, vldl, or idl (i.e., hyperlipoproteinemia types i, iii, iv, or v). fluvastatin sodium extended-release tablets are contraindicated in patients with hypersensitivity to any component of this medication. fluvastatin sodium extended-release tablets are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see warnings and precautions (5.2)] . fluvastatin sodium extended-release tablets are contraindicated in women who are pregnant or may become pregnant. serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. fluvastatin may cause fetal harm when administered to pregnant women. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. fluvastatin sodium extended-release tablets should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards . if the patient becomes pregnant while taking this drug, fluvastatin sodium extended-release tablets should be discontinued and the patient should be apprised of the potential hazard to the fetus [see use in specific populations (8.1)] . fluvastatin is secreted into the breast milk of animals and because hmg-coa reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with fluvastatin sodium extended-release tablets should be advised not to breastfeed their infants [see use in specific populations (8.3)] . pregnancy category x fluvastatin is contraindicated in women who are or may become pregnant [see contraindications (4)] . lipid lowering drugs are contraindicated during pregnancy, because cholesterol and cholesterol derivatives are needed for normal fetal development. serum cholesterol and triglycerides increase during normal pregnancy. atherosclerosis is a chronic process, and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long-term outcomes of primary hypercholesterolemia therapy. there are no adequate and well-controlled studies of use with fluvastatin during pregnancy. rare reports of congenital anomalies have been received following intrauterine exposure to other statins. in a review 2 of about 100 prospectively followed pregnancies in women exposed to other statins, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed the rate expected in the general population. the number of cases is adequate only to exclude a 3- to 4-fold increase in congenital anomalies over background incidence. in 89% of prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.   teratology studies with fluvastatin in rats and rabbits showed maternal toxicity at high dose levels, but there was no evidence of embryotoxic or teratogenic potential [see non-clinical toxicology (13)] .  fluvastatin should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazards. if a woman becomes pregnant while taking fluvastatin sodium extended-release tablets, the drug should be discontinued and the patient advised again as to the potential hazards to the fetus. based on animal data, fluvastatin is present in breast milk in a 2:1 ratio (milk:plasma). because of the potential for serious adverse reactions in nursing infants, nursing women should not take fluvastatin [see contraindications (4)] . the safety and efficacy of fluvastatin in children and adolescent patients 9-16 years of age with heterozygous familial hypercholesterolemia have been evaluated in open-label, uncontrolled clinical trials for a duration of two years. the most common adverse events observed were influenza and infections. in these limited uncontrolled studies, there was no detectable effect on growth or sexual maturation in the adolescent boys or on menstrual cycle length in girls [see clinical studies (14.2), adverse reactions (6.3) and dosage and administration (2.2)] . adolescent females should be counseled on appropriate contraceptive methods while on fluvastatin therapy [see contraindications (4)] . fluvastatin exposures were not significantly different between the nonelderly and elderly populations (age ≥ 65 years) [see clinical pharmacology (12.3)] . since advanced age ( > 65 years) is a predisposing factor for myopathy, fluvastatin should be prescribed with caution in the elderly. fluvastatin is contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see clinical pharmacology (12.3)] . dose adjustments for mild to moderate renal impairment are not necessary. fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore caution should be exercised when treating such patients at higher doses [see clinical pharmacology (12.3)] .

Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

genzyme therapeutics ltd - teriflunomide - tablet - 14mg

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 119.5mg equivalent to imatinib base 100 mg;   - film coated tablet - 100 mg - active: imatinib mesilate 119.5mg equivalent to imatinib base 100 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - imatinib mesilate 478mg equivalent to imatinib base 400 mg;   - film coated tablet - 400 mg - active: imatinib mesilate 478mg equivalent to imatinib base 400 mg   excipient: colloidal silicon dioxide crospovidone hypromellose magnesium stearate microcrystalline cellulose opadry red 00f15613 opadry yellow 00f12951 purified water - · treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive chronic myeloid leukaemia (ph+cml). · treatment of adult and paediatic patients with ph+cml in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. · treatment of adult patients with new diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+all) integrated with chemotherapy. · treatment of adult patients with relapsed or refractory ph+all as monotherapy. · treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. · treatment of adult patients with systemic mastocytosis (sm) without the d816v c-kit mutation or with c-kit mutational status unknown. · treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel). · treatment of adult patients with kit+ (cd117) unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). · adjuvant treatment of adult patients following resection of kit+gist. · treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).

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

alphapharm pty ltd - hydralazine hydrochloride, quantity: 25 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; disodium edetate; purified talc - this product accepted for registration as 'currently supplied' at the time of commencement of the act. variation to pregnancy statement in product information were approved as specified in the letter of 13 august 1992 from dr bijoy varma. indicated for the treatment of drug resistant, moderate to severe, hypertension. this drug is not a first line antihypertensive drug and is better used in combination with other therapy such as a sympatholytic agent and a diuretic. indications as at 28 november 2001 : hypertension (drug resistant, moderate to severe): as supplementary medication for use together with other antihypertensives such as "beta"-blockers and diuretics; the complementary mechanisms of action of such combined therapy enable the drugs to exert their antihypertensive effects at low doses; in addition, unwanted accompanying effects of the individual substances are either partially offset or even cancelled out.

Marekani - Kiingereza - NLM (National Library of Medicine)

tya pharmaceuticals - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine 150 mg - oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 2 years and above with partial seizures. oxcarbazepine tablets should not be used in patients with a known hypersensitivity to oxcarbazepine or to any of its components. oxcarbazepine tablets levels may decrease during pregnancy [see ]. warnings and precautions (5.10) pregnancy category c there are no adequate and well-controlled clinical studies of oxcarbazepine tablets in pregnant women; however, oxcarbazepine tablets is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. given this fact, and the results of the animal studies described, it is likely that oxcarbazepine tablets is a human teratogen. oxcarbazepine tablets should be used during pregnancy only i

Marekani - Kiingereza - NLM (National Library of Medicine)

physicians total care, inc. - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - divalproex sodium 500 mg - divalproex sodium extended-release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies (14.1)] . the safety

Marekani - Kiingereza - NLM (National Library of Medicine)

proficient rx lp - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - major depressive disorder: bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical trials ). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration

Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

a. menarini farmaceutica internazionale srl - tramadol hydrochloride; dexketoprofen - oral tablet - 75mg ; 25mg