Nyuzilandi - Kiingereza - Medsafe (Medicines Safety Authority)

biogen nz biopharma ltd - peginterferon beta-1a 125ug;   - solution for injection - 125 mcg/0.5ml - active: peginterferon beta-1a 125ug   excipient: arginine hydrochloride glacial acetic acid polysorbate 20 sodium acetate trihydrate water for injection - plegridy is indicated for the treatment of relapsing forms of multiple sclerosis

Marekani - Kiingereza - NLM (National Library of Medicine)

galena biopharma, inc. - fentanyl citrate (unii: mun5lyg46h) (fentanyl - unii:uf599785jz) - fentanyl 100 ug - abstral (fentanyl) sublingual tablets are indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. patients considered opioid tolerant are those who are taking around-theclock medicine consisting of at least 60 mg of oral morphine daily, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid medication daily for a week or longer. patients must remain on around-the-clock opioids when taking abstral . abstral is contraindicated for patients who are not already tolerant to opioids because life-threatening respiratory depression and death could result at any dose in patients not on a chronic regimen of opioids. for this reason, abstral is contraindicated in the management of acute or postoperative pain,

Marekani - Kiingereza - NLM (National Library of Medicine)

wyeth biopharma division of wyeth pharmaceuticals llc - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 1000 [iu] in 5 ml - benefix® , coagulation factor ix (recombinant), is a human blood coagulation factor indicated in adults and children with hemophilia b (congenital factor ix deficiency or christmas disease) for: limitation of use benefix is not indicated for induction of immune tolerance in patients with hemophilia b [see warnings and precautions (5.3)] . benefix is contraindicated in patients who have manifested life-threatening, immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster protein. risk summary there are no data with benefix use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with benefix. it is not known whether benefix can affect reproductive capacity or cause fetal harm when given to pregnant women. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. risk summary there is no informa

Marekani - Kiingereza - NLM (National Library of Medicine)

wyeth biopharma division of wyeth pharmaceuticals llc - moroctocog alfa (unii: 113e3z3cjj) (moroctocog alfa - unii:113e3z3cjj) - antihemophilic factor, human recombinant residues 743-1636 deleted 1000 [iu] in 4 ml - xyntha, antihemophilic factor (recombinant), is indicated for use in adults and children with hemophilia a (congenital factor viii deficiency) for: xyntha does not contain von willebrand factor, and therefore is not indicated in patients with von willebrand's disease. xyntha is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins. risk summary it is not known whether xyntha can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. animal reproduction studies have not been conducted with xyntha. there is no information available on the effect of factor viii replacement therapy on labor and delivery. xyntha should be used only if clinically indicated. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. risk summary there is

Marekani - Kiingereza - NLM (National Library of Medicine)

eisai inc. - palonosetron hydrochloride (unii: 23310d4i19) (palonosetron - unii:5d06587d6r) - palonosetron 0.25 mg in 5 ml - aloxi is indicated for: - moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses - highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses aloxi is indicated for prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. aloxi is indicated for prevention of postoperative nausea and vomiting (ponv) for up to 24 hours following surgery. efficacy beyond 24 hours has not been demonstrated. as with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients where nausea and vomiting must be avoided during the postoperative period, aloxi is recommended even where the incidence of postoperative nausea and/or vomiting is low. aloxi is contraindicat

Marekani - Kiingereza - NLM (National Library of Medicine)

kedrion biopharma, inc. - human immunoglobulin g (unii: 66y330cjhs) (human immunoglobulin g - unii:66y330cjhs) - human immunoglobulin g 1 g in 10 ml - bivigam is an immune globulin intravenous (human), 10% liquid, indicated for the treatment of patients with primary humoral immunodeficiency (pi). this includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (cvid), x-linked agammaglobulinemia, congenital agammaglobulinemia, wiskott-aldrich syndrome, and severe combined immunodeficiencies. - bivigam is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - bivigam is contraindicated in iga deficiency patients with antibodies to iga and a history of hypersensitivity. pregnancy category c. animal reproduction studies have not been conducted with bivigam. it is not known whether bivigam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. bivigam should be given to pregnant women only if clearly needed.17,18 use of bivigam in nursing mothers has not been evaluated. bivigam should be given to nursing m

Marekani - Kiingereza - NLM (National Library of Medicine)

navidea biopharmaceuticals, inc. - technetium tc-99m tilmanocept (unii: 8ihi69pqtc) (technetium tc-99m tilmanocept - unii:8ihi69pqtc) - tilmanocept 250 ug - lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: - lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management. - guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. none. pregnancy category c there are no adequate or well-controlled studies of lymphoseek in pregnant women. additionally, animal reproduction studies have not been conducted with technetium tc 99m tilmanocept. however, all radiopharmaceuticals, including lymphoseek, have a potential to cause fetal harm. lymphoseek should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. it is not known whether technetium tc 99m tilmanocept is present in human milk.  based on the half-life of technetiu

Marekani - Kiingereza - NLM (National Library of Medicine)

heritage pharmaceuticals labs inc. d/b/a avet pharmaceuticals labs inc. - acetazolamide sodium (unii: 429zt169uh) (acetazolamide - unii:o3fx965v0i) - acetazolamide 500 mg in 5 ml - for adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. acetazolamide is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent. hypersensitivity to acetazolamide or any excipients in the formulation. since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. it is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. long-term administration of acetazolamide is contraindicated in patients with chronic noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - glycopyrronium bromide - oral tablet - 1mg

Uingereza - Kiingereza - MHRA (Medicines & Healthcare Products Regulatory Agency)

morningside healthcare ltd - glycopyrronium bromide - oral tablet - 2mg