Kanada - İngilizce - Health Canada

novopharm limited - dipyridamole - solution - 5mg - dipyridamole 5mg - miscellaneous vasodilatating agents

ABD - İngilizce - NLM (National Library of Medicine)

endo usa, inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - supprelin la (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puberty (cpp). children with cpp (neurogenic or idiopathic) have an early onset of secondary sexual characteristics (earlier than 8 years of age in females and 9 years of age in males). they also show a significantly advanced bone age that can result in diminished adult height attainment. prior to initiation of treatment a clinical diagnosis of cpp should be confirmed by measurement of blood concentrations of total sex steroids, luteinizing hormone (lh) and follicle stimulating hormone (fsh) following stimulation with a gnrh analog, and assessment of bone age versus chronological age. baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroids to exclude congenital adrenal hyperplasia. supprelin la is contraindicated in: - patients who are hypersensitive to gonadotropin releasing hormone (gnrh) or gnrh agonist analogs - pregnancy [see use in specific populations (8.1) ]. risk summary supprelin la is contraindicated during pregnancy [see contraindications (4)] since expected hormonal changes that occur with supprelin la treatment increase the risk for pregnancy loss. the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. consistent with mechanism of action for supprelin la [see clinical pharmacology (12.1)], animal reproduction studies showed an increase in fetal loss at clinically relevant exposures. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data histrelin acetate administered to pregnant rats during the period of organogenesis increased fetal mortality and post-implantation loss at doses of 1, 3, 5 or 15 mcg/kg/day, approximating clinical exposure based on body surface area. these dosages also reduced maternal body weight gain, stimulated ovarian follicular development, increased placental weight and caused abnormal morphology and an increase in fetal size. histrelin acetate administered to pregnant rabbits during the period of organogenesis increased fetal mortality and abortion/early termination at the two highest doses and caused total litter loss at all doses of 20, 50 or 80 mcg/kg/day (approximately 3- to 12-times clinical exposures based on body surface area). risk summary there are no data on the presence of supprelin la in human or animal milk, the effects on the breastfed infant, or the effects on milk production. absorption and systemic activity are not expected from potential exposure to the peptide, histrelin, in the breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for supprelin la and any potential adverse effects on the breastfed child from supprelin la or from the underlying maternal condition. safety and effectiveness in pediatric patients below the age of 2 years have not been established. the use of supprelin la in children under 2 years is not recommended.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

novo nordisk a/s - insulin human - diabetes mellitus - drugs used in diabetes - treatment of diabetes mellitus.

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

animedica gmbh - enrofloxacin - solution for injection - 25 milligram(s)/millilitre - enrofloxacin

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

animedica gmbh - enrofloxacin - solution for injection - 50 milligram(s)/millilitre - enrofloxacin

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

eisai australia pty ltd - eribulin mesilate -

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - paclitaxel - concentrate for solution for infusion - 6 milligram(s)/millilitre - taxanes; paclitaxel

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

alfred e tiefenbacher (gmbh & co. kg) - docetaxel anhydrous - concentrate for soln for inf - 20 mg/ml

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

alfred e tiefenbacher (gmbh & co. kg) - docetaxel anhydrous - concentrate for soln for inf - 80 10 milligram