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

bamf health inc. - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - sodium fluoride f 18 injection is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodium fluoride f 18 injection or not to administer sodium fluoride f 18 injection, taking into account the importance of the drug to the mother. the body of scientific information related to radioactive decay, drug tissue distribution, and drug elimination shows that less than 0.01% of the radioactivity administered remains in the body after 24 hours (10 half-lives). to minimize the risks to a nursing infant, interrupt nursing for at least 24 hours. in reported clinical experience in approximately 100 children, weight based doses (2.1 mbq/kg) ranging from 19 mbq-148 mbq (0.5 mci-4 mci) were used. sodium fluoride f 18 was shown to localize to areas of bone turnover including rapidly growing epiphyses in developing long bones. children are more sensitive to radiation and may be at higher risk of cancer from sodium fluoride f 18 injection.

Ireland - English - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - voriconazole - powder for solution for infusion - 200 milligram(s) - voriconazole

Ireland - English - HPRA (Health Products Regulatory Authority)

xellia pharmaceuticals aps - voriconazole - powder for solution for infusion - 200 milligram(s) - triazole derivatives; voriconazole

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

pfizer ltd - voriconazole - powder for solution for infusion - 200mg

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

panpharma uk ltd - voriconazole - powder for solution for infusion - 200mg

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

actavis uk ltd - voriconazole - powder for solution for infusion - 200mg

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

pfizer ltd - inotuzumab ozogamicin - powder for solution for infusion - 1mg

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, potassium chloride, sodium chloride, sodium lactate - solution for infusion - calcium chloride dihydrate 0.27 g/l potassium chloride 0.4 g/l sodium chloride 6 g/l sodium lactate 3.2 g/l - blood substitutes and perfusion solutions

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

pfizer ltd - voriconazole - powder for solution for infusion - 200mg