United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - foscarnet sodium - solution for infusion - 24mg/1ml

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

clinigen limited - foscarnet sodium (unii: 964ys0oog1) (foscarnet - unii:364p9rvw4x) - foscarnet sodium 24 mg in 1 ml - foscavir is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids). combination therapy with foscavir and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. safety and efficacy of foscavir have not been established for treatment of other cmv infections (e.g., pneumonitis, gastroenteritis); congenital or neonatal cmv disease; or nonimmunocompromised individuals. foscavir is indicated for the treatment of acyclovir-resistant mucocutaneous hsv infections in immunocompromised patients. safety and efficacy of foscavir have not been established for treatment of other hsv infections (e.g., retinitis, encephalitis); congenital or neonatal hsv disease; or hsv in nonimmunocompromised individuals. foscavir is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.

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

clinigen limited - foscarnet sodium (unii: 964ys0oog1) (foscarnet - unii:364p9rvw4x) - foscavir is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids). combination therapy with foscavir and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. safety and efficacy of foscavir have not been established for treatment of other cmv infections (e.g., pneumonitis, gastroenteritis); congenital or neonatal cmv disease; or nonimmunocompromised individuals. foscavir is indicated for the treatment of acyclovir-resistant mucocutaneous hsv infections in immunocompromised patients. safety and efficacy of foscavir have not been established for treatment of other hsv infections (e.g., retinitis, encephalitis); congenital or neonatal hsv disease; or hsv in nonimmunocompromised individuals. foscavir is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.

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

clinigen limited - foscarnet sodium (unii: 964ys0oog1) (foscarnet - unii:364p9rvw4x) - foscavir is indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids). combination therapy with foscavir and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. safety and efficacy of foscavir have not been established for treatment of other cmv infections (e.g., pneumonitis, gastroenteritis); congenital or neonatal cmv disease; or nonimmunocompromised individuals. foscavir is indicated for the treatment of acyclovir-resistant mucocutaneous hsv infections in immunocompromised patients. safety and efficacy of foscavir have not been established for treatment of other hsv infections (e.g., retinitis, encephalitis); congenital or neonatal hsv disease; or hsv in nonimmunocompromised individuals. foscavir is contraindicated in patients with clinically significant hypersensitivity to foscarnet sodium.

European Union - English - EMA (European Medicines Agency)

clinigen healthcare b.v. - dexrazoxane hydrochloride - extravasation of diagnostic and therapeutic materials - all other therapeutic products - savene is indicated for the treatment of anthracycline extravasation.

Ireland - English - HPRA (Health Products Regulatory Authority)

clinigen healthcare b.v. - melatonin - oral solution - melatonin

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

clinigen healthcare ltd - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - dexrazoxane 500 mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - dexrazoxane - powder and solvent for solution for infusion - 500mg

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

clinigen limited - aldesleukin (unii: m89n0q7eqr) (aldesleukin - unii:m89n0q7eqr) - proleukin is indicated for the treatment of adults with metastatic renal cell carcinoma (rcc). proleukin is indicated for the treatment of adults with metastatic melanoma. - severe hypersensitivity reactions proleukin is contraindicated in patients with a known history of severe hypersensitivity to aldesleukin or any component of the proleukin formulation [see adverse reactions (6.2)]. - organ allografts proleukin is contraindicated in patients with organ allografts [see warnings and precautions (5.5)] . - significant organ impairment proleukin is contraindicated in patients with significant cardiac (including those with an abnormal cardiac ejection fraction, impaired wall motion, or significant coronary artery disease), pulmonary (including those with an fev1 ≤ 2 liters or < 75% predicted for height and age), renal, hepatic, or cns impairment [see warnings and precautions (5.1, 5.2, 5.4)] . risk summary based on findings in an animal study and its mechanism of action, proleukin may cause fetal harm or los

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

clinigen limited - dexrazoxane hydrochloride (unii: 5346058q7s) (dexrazoxane - unii:048l81261f) - extravasation totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy. cardiomyopathy totect is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. do not use with the initiation of doxorubicin therapy [see warnings and precautions (5.2)] . none. risk summary based on findings from animal studies and its mechanism of action, totect can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited available data with totect use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at mat