Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by women to prevent pregnancy. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associat

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levomefolate calcium (unii: a9r10k3f2f) (levomefolic acid - unii:8s95dh25xc) - drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by women to prevent pregnancy. drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are also indicated for the treatment of symptoms of premenstrual dysphoric disorder (pmdd) in women who choose to use an oral contraceptive as their method of contraception. the effectiveness of drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets for pmdd when used for more than three menstrual cycles has not been evaluated. the essential features of pmdd according to the diagnostic and statistical manual-4th edition (dsm-iv) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associat

Združene države Amerike - angleščina - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - previfem® (norgestimate/ethinyl estradiol tablets) and tri-previfem® (norgestimate/ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® (norgestimate/ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. previfem® (norgestimate/ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . do not prescribe previfem® or tri-previfem® to women who are known to have the following conditions: - 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 [s

Združene države Amerike - angleščina - NLM (National Library of Medicine)

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - previfem® (norgestimate/ethinyl estradiol tablets) and tri-previfem® (norgestimate/ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . tri-previfem® (norgestimate/ethinyl estradiol tablets) is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. previfem® (norgestimate/ethinyl estradiol tablets) should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . do not prescribe previfem® or tri-previfem® to women who are known to have the following conditions: - 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 [s

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - ethinyl estradiol 0.025 mg - tri-lo-marzia™ tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. do not prescribe tri-lo-marzia to women who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:    o  smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]    o  have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]    o  have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]    o  have cerebrovascular disease [see warnings and precautions (5.1)]    o  have coronary artery disease [see warnings and precautions (5.1)]    o  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)]    o  have uncontrolled hypertension [see warnings and precaution

Združene države Amerike - angleščina - NLM (National Library of Medicine)

proficient rx lp - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - ethinyl estradiol 0.025 mg - tri-lo-marzia™ tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. do not prescribe tri-lo-marzia to women who are known to have the following conditions:    o  smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]    o  have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]    o  have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]    o  have cerebrovascular disease [see warnings and precautions (5.1)]    o  have coronary artery disease [see warnings and precautions (5.1)]    o  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)]    o  have uncontrolled hypertension [see warnings and precautions (5.3)]    o  have diabetes mellitus with vascular disease [see warnings and precautions (5.5)]    o  

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin limited - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy) - ethinyl estradiol 0.025 mg - tri-lo-marzia™ tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)]. do not prescribe tri-lo-marzia to women who are known to have the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to:    o  smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)]    o  have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)]    o  have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)]    o  have cerebrovascular disease [see warnings and precautions (5.1)]    o  have coronary artery disease [see warnings and precautions (5.1)]    o  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)]    o  have uncontrolled hypertension [see warnings and precaution

Združene države Amerike - angleščina - NLM (National Library of Medicine)

janssen pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.180 mg - ortho-cyclen and ortho tri-cyclen tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . ortho tri-cyclen is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ortho tri-cyclen should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see clinical studies (14)] . ortho-cyclen and ortho tri-cyclen are contraindicated in females who are known to have or develop the following conditions: - 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)]

Združene države Amerike - angleščina - NLM (National Library of Medicine)

northstar rx llc - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.25 mg - mono-linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies ( 14)] . do not prescribe mono-linyah to women who are known to have the following conditions: - 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 inherited or acquired hypercoagulopathies[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 uncontrolled hypertension[see warnings and precautions (5.4)] have diabetes mellitus with vasc

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), drospirenone (unii: n295j34a25) (drospirenone - unii:n295j34a25) - drospirenone and ethinyl estradiol tablet usp is indicated for use by women to prevent pregnancy. drospirenone and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: - renal impairment - adrenal insufficiency  - 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