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

care pharmaceuticals pty ltd - zinc oxide -

Stati Uniti - inglese - NLM (National Library of Medicine)

meda pharmaceuticals - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - astelin nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. limited data from postmarketing experience over decades of use with astelin in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose.  oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096 mg. however, the relevance of these findings

Stati Uniti - inglese - NLM (National Library of Medicine)

physicians total care, inc. - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - astelin® nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. astelin® nasal spray is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components. for intranasal use only important: follow instructions carefully to ensure proper dosing. dosing: the dosage of astelin® nasal spray is 1 spray per nostril twice daily for pediatric patients (ages 5-11 years) with seasonal allergic rhinitis. for patients age 12 and older with seasonal allergic rhinitis the dosage is one or two sprays per nostril twice daily. for patients age 12 and older with nonallergic vasomotor rhinitis the dosage is two sprays per nostril twice daily. keep your head tilted downward when spraying. alternate s

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

novartis pharmaceuticals australia pty ltd - inclisiran, quantity: 284 mg - injection, solution - excipient ingredients: sodium hydroxide; phosphoric acid; water for injections - leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (ldl-c) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:,? in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,,? alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.

Stati Uniti - inglese - 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.

Unione Europea - inglese - EMA (European Medicines Agency)

atnahs pharma netherlands b.v. - macimorelin acetate - diagnostic techniques, endocrine - macimorelin - this medicinal product is for diagnostic use only. ghryvelin is indicated for the diagnosis of growth hormone deficiency (ghd) in adults.

Stati Uniti - inglese - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Stati Uniti - inglese - NLM (National Library of Medicine)

aurobindo pharma limited - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline hydrochloride capsules are contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Stati Uniti - inglese - NLM (National Library of Medicine)

advagen pharma ltd - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline is indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.

Stati Uniti - inglese - NLM (National Library of Medicine)

bionpharma inc - cevimeline hydrochloride (unii: p81q6v85np) (cevimeline - unii:k9v0cdq56e) - cevimeline hydrochloride capsules are indicated for the treatment of symptoms of dry mouth in patients with sjögren’s syndrome. cevimeline is contraindicated in patients with uncontrolled asthma, known hypersensitivity to cevimeline, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle-closure) glaucoma.