European Union - English - EMA (European Medicines Agency)

provepharm sas - methylthioninium chloride - methemoglobinemia - all other therapeutic products - acute symptomatic treatment of medicinal and chemical products- induced methaemoglobinaemia.methylthioninium chloride proveblue is indicated in adults, children and adolescents (aged 0 to 17 years old).

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

provepharm inc. - dihydroergotamine mesylate (unii: 81axn7r2qt) (dihydroergotamine - unii:436o5hm03c) - dihydroergotamine mesylate injection, usp is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes. there have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent cyp3a4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. the use of potent cyp3a4 inhibitors (i.e., ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with dihydroergotamine is, therefore, contraindicated (see warnings, cyp3a4 inhibitors). dihydroergotamine mesylate injection, usp should not be given to patients with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm including prinzmetal's variant an

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

provepharm inc. - indigotindisulfonate sodium (unii: d3741u8k7l) (indigotindisulfonic acid - unii:x7oi7jf73p) - bludigo is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures. bludigo is contraindicated in patients with known hypersensitivity to indigotindisulfonate or any of its components [see warnings and precautions (5.2)]. risk summary available data from case reports, case series, observational studies and clinical experience with indigotindisulfonate sodium injection use in pregnant women over several decades have not identified a drug associated risk of adverse maternal and fetal adverse effects. indigotindisulfonate sodium injection use during the first trimester of pregnancy is rare; thus, the data are insufficient to evaluate for a drug associated risk of major birth defects and miscarriage. the majority of the published data were from intra-amniotic injections. animal reproduction studies using the intravenous route of administration have not been conducted.

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

provepharm sas, france - methylthioninium chloride - solution for injection - 5 mg/ml,

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

provepharm sas, france - methylthioninium chloride - solution for injection - 5 mg/ml,

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

clinect pty ltd - methylene blue, quantity: 50 mg - injection - excipient ingredients: water for injections - proveblue is indicated: for the treatment of drug-induced methaemoglobinaemia. for the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobulin is not present). as a bacterial stain. as a dye in diagnostic procedures such as fistula detection. for the delineation of certain body tissues during surgery.

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

martindale pharmaceuticals ltd - methylthioninium chloride - solution for injection - 5mg/1ml

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

provepharm inc. - penicillin g benzathine (unii: rit82f58gk) (penicillin g - unii:q42t66vg0c) -