United States - English - NLM (National Library of Medicine)

organon usa inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - remeronsoltab (mirtazapine) orally disintegrating tablets are indicated for the treatment of major depressive disorder. the efficacy of remeron (mirtazapine) tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest 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, a suicide attempt, or suicidal ideation. the ef

United States - English - NLM (National Library of Medicine)

organon usa inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 45 mg - remeron/remeronsoltab are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . remeron/remeronsoltab is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.3), drug interactions (7)] . - with a known hypersensitivity to mirtazapine or to any of the excipients in remeron/remeronsoltab. severe skin reactions, including stevens-johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of remeron/remeronsoltab [see adverse reactions 6.2]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or

Israel - English - Ministry of Health

organon pharma israel ltd., israel - alendronic acid as alendronate sodium trihydrate; colecalciferol - tablets - colecalciferol 140 mcg; alendronic acid as alendronate sodium trihydrate 70 mg - colecalciferol - fosavance is indicated for : - treatment of osteoporosis in postmenopausal women: fosavance increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). - treatment to increase bone mass in men with osteoporosis.

Israel - English - Ministry of Health

organon pharma israel ltd., israel - alendronate as sodium - tablets - alendronate as sodium 70 mg - alendronic acid - alendronic acid - fosalan is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). treatment to increase bone mass in men with osteoporosis.

United States - English - NLM (National Library of Medicine)

organon usa inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh) - etonogestrel 68 mg - implanon® is indicated for use by women to prevent pregnancy. implanon should not be used in women who have - known or suspected pregnancy - current or past history of thrombosis or thromboembolic disorders - liver tumors, benign or malignant, or active liver disease - undiagnosed abnormal genital bleeding - known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past - allergic reaction to any of the components of implanon [see adverse reactions (6)] risk summary implanon is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant [see contraindications (4)] . epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse development outcomes were observed in pregnant rats

United States - English - NLM (National Library of Medicine)

organon usa inc. - ganirelix acetate (unii: 56u7906fqw) (ganirelix - unii:ix503l9wn0) - ganirelix acetate 250 ug in 0.5 ml - ganirelix acetate injection is indicated for the inhibition of premature lh surges in women undergoing controlled ovarian hyperstimulation. ganirelix acetate injection is contraindicated under the following conditions: - known hypersensitivity to ganirelix acetate or to any of its components including dry natural rubber/latex (see how supplied). - known hypersensitivity to gnrh or any other gnrh analog. - known or suspected pregnancy (see precautions).

United States - English - NLM (National Library of Medicine)

organon usa inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - etonogestrel 0.12 mg in 1 d - for vaginal use only nuvaring® is indicated for use by females of reproductive age to prevent pregnancy. do not prescribe nuvaring to women who are known to have or use the following: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.5)] have diabetes mellitus with vascular disease [see wa

United States - English - NLM (National Library of Medicine)

organon usa inc. - etonogestrel (unii: 304gth6rnh) (etonogestrel - unii:304gth6rnh) - etonogestrel 68 mg - nexplanon® is indicated for use by women to prevent pregnancy. nexplanon should not be used in women who have - known or suspected pregnancy - current or past history of thrombosis or thromboembolic disorders - liver tumors, benign or malignant, or active liver disease - undiagnosed abnormal genital bleeding - known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer, now or in the past - allergic reaction to any of the components of nexplanon [see adverse reactions (6)] risk summary nexplanon is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant [see contraindications (4)] . epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose chcs prior to conception or during early pregnancy. no adverse development outcomes were observed in pregnant rats a

Singapore - English - HSA (Health Sciences Authority)

organon singapore pte. ltd. - obstetrics & gynaecology - the organon jada® system is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Israel - English - Ministry of Health

organon pharma israel ltd., israel - losartan potassium - tablets - losartan potassium 50 mg - losartan - losartan - hypertension: ocsaar 50 mg is indicated for the treatment of hypertensionheart failure: ocsaar 50 mg is indicated for the treatment of heart failure, usually in addition to diuretics and/or digitalis, if use of an ace inhibitor is not appropriate.switching patients with heart failure who are stable on an ace inhibitor to ocsaar 50 mg is not recommended.renal protection in type-2 diabetic patients with proteinuria: ocsaar 50 mg is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria.reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy. ocsaar 50 mg is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy.the benefit of ocsaar 50 mg on the primary deposite endpoint was largely driven by reduction in the risk of stroke.