Izrael - angličtina - Ministry of Health

organon pharma israel ltd., israel - desogestrel; ethinylestradiol - tablets - desogestrel 150 mcg; ethinylestradiol 20 mcg - desogestrel - desogestrel - oral contraception

Izrael - angličtina - Ministry of Health

merck sharp & dohme israel ltd - desogestrel; ethinylestradiol - tablets - desogestrel 150 mcg; ethinylestradiol 20 mcg - desogestrel - desogestrel - oral contraception

Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - desogestrel; ethinylestradiol - oral tablet - 150microgram ; 20microgram

Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - desogestrel; ethinylestradiol - oral tablet - 150microgram ; 30microgram

Spojené státy - angličtina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), norethindrone (unii: t18f433x4s) (norethindrone - unii:t18f433x4s) - kaitlib™ fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. the efficacy of kaitlib fe in women with a body mass index (bmi) of > 35 kg/m2 has not been evaluated. kaitlib fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is 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:     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 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 inherited or acquired hypercoagulopathies [see  warnings  and  precautions  (5.1)]     o    have uncontrolled hypertension [see  warnings  and  precautions  (5.5)]     o    have diabetes with vascular disease [see  warnings  and  precautions  (5.7)]     o    have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see  warnings  and  precautions  (5.8)] - current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see warnings and precautions (5.2)] - liver tumors, benign or malignant, or liver disease [see warnings and precautions (5.3) , use in specific populations (8.7) , and clinical pharmacology (12.3)] - undiagnosed abnormal uterine bleeding [see warnings and precautions (5.9)] - use of hepatitis c drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for alt elevations [see warnings and precautions (5.4)] risk summary there is no use for contraception in pregnancy; therefore, kaitlib fe should be discontinued during pregnancy. epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to cocs before conception or during early pregnancy. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary contraceptive hormones and/or metabolites are present in human milk. cocs can reduce milk production in breast-feeding females. this reduction can occur at any time but is less likely to occur once breast-feeding is well-established. when possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [see dosage and administration (2.2) ]. the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for kaitlib fe and any potential adverse effects on the breast-fed child from kaitlib fe or from the underlying maternal condition. safety and efficacy of kaitlib fe have been established in women of reproductive age. efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. use of this product before menarche is not indicated. kaitlib fe have not been studied in postmenopausal women and is not indicated in this population. the pharmacokinetics of kaitlib fe has not been studied in subjects with renal impairment. no studies have been conducted to evaluate the effect of hepatic disease on the disposition of kaitlib fe. however, steroid hormones may be poorly metabolized in patients with impaired liver function. acute or chronic disturbances of liver function may necessitate the discontinuation of coc use until markers of liver function return to normal [see  contraindications  (4) , and  warnings  and  precautions  (5.3)]. the safety and efficacy of kaitlib fe in women with a bmi > 35 kg/m2 have not been evaluated.

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

viatris limited - itraconazole 100mg;   - capsule - 100 mg - active: itraconazole 100mg   excipient: capsugel red g60csa00150 colloidal silicon dioxide ethanol gelatin hypromellose iron oxide red methylene chloride opacode white s-1-7078 purified water sorbitan stearate sugar spheres titanium dioxide - itraconazole capsules are indicated for the treatment of: · vulvovaginal candidiasis. · pityriasis versicolor, · dermatomycosis - including highly keratinised regions as in plantar tinea pedis and palmer tinea manus, · fungal keratitis, · oral candidiasis, · onychomycosis caused by dermatophytes and/or yeasts. · systemic mycoses, only in the following fungal infections: - systemic aspergillosis - histoplasmosis, - histoplasmosis, maintenance therapy only in aids patients - sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous) - paraconccidioidomycosis, - chromomycosis, - blastomycosis

Spojené státy - angličtina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u), levonorgestrel (unii: 5w7sia7yzw) (levonorgestrel - unii:5w7sia7yzw) - ethinyl estradiol 0.03 mg - oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. oral contraceptives are highly effective. table ii lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. the efficacy of these contraceptive methods, except sterilization and the iud, depends upon the reliability with which they are used. correct and consistent use of methods can result in lower failure rates. na - not available combination oral contraceptives should not be used in women with any of the following conditions: thrombophlebitis or thromboembolic disorders. a past history of deep-vein thrombophlebitis or thromboembolic disorders. cerebral-vascular or coronary-artery disease. thrombogenic valvulopathies. thrombogenic rhythm disorders. diabetes with vascular involvement. uncontrolled hypertension. known or suspected carcinoma of the breast. carcinoma of the endometrium or other known or suspecte

Velká Británie - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

gedeon richter (uk) ltd - ethinylestradiol; levonorgestrel - oral tablet - 30microgram ; 150microgram

Malajsie - angličtina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

vitamode sdn.bhd - desogestrel; ethinylestradiol -

Izrael - angličtina - Ministry of Health

bayer israel ltd - ethinylestradiol; gestodene - coated tablets - ethinylestradiol 0.020 mg; gestodene 0.075 mg - gestodene and estrogen - oral contraceptive.