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

sanofi pasteur inc. - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) (unii: c4hqf74xmw) (rabies virus strain pm-1503-3m antigen (propiolactone inactivated) - unii:c4hqf74xmw) - rabies virus strain pm-1503-3m antigen (propiolactone inactivated) 2.5 [iu] in 1 ml - imovax rabies is a vaccine indicated for pre-exposure and post-exposure prophylaxis against rabies. imovax rabies vaccine is approved for use in all age groups. physicians must evaluate each possible rabies exposure. local or state public health officials should be consulted if questions arise about the need for prophylaxis. (11) the following factors should be considered before antirabies prophylaxis is initiated. rabid bats have been documented in the 49 continental states, and bats are increasingly implicated as important wildlife reservoirs for variants of rabies virus transmitted to humans. transmission of rabies virus can occur from minor, seemingly underappreciated or unrecognized bites from bats (see table 2). (11) raccoons, skunks, and foxes are the terrestrial carnivores most often infected with rabies in the united states. suggestive clinical signs of rabies among wildlife cannot be interpreted reliably. all bites by such wildlife should be considered possible exposures to rabies virus. post-exposu

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

sanofi pasteur inc. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (formaldehyde inactivated) (unii: xw4jb03ti5) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:92xe6ghc89), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (formaldehyde inactivated) (unii: 3nzw5nd3d6) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:k329ycd1n9), influenza b virus b/maryland/15/2016 bx-69a antigen (formaldeh - influenza a virus a/michigan/45/2015 x-275 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 60 ug in 0.5 ml - fluzone® high-dose is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b virus contained in the vaccine. fluzone high-dose is approved for use in persons 65 years of age and older. a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11) ], including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of fluzone high-dose. fluzone high-dose is not approved for use in persons <65 years of age. there are limited human data and no animal data available to establish whether there is a vaccine-associated risk with use of fluzone high-dose in pregnancy. fluzone high-dose is not approved for use in persons <65 years of age. no human or animal data are available to assess the effects of fluzone high-dose on the breastfed infant or on milk production/excretion. safety and effectiveness of fluzone high-dose in persons <65 years of age have not bee

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

sanofi pasteur inc. - clostridium tetani toxoid antigen (formaldehyde inactivated) (unii: k3w1n8yp13) (clostridium tetani toxoid antigen (formaldehyde inactivated) - unii:k3w1n8yp13), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) (unii: irh51qn26h) (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) - unii:irh51qn26h) - clostridium tetani toxoid antigen (formaldehyde inactivated) 5 [lf] in 0.5 ml - tenivac® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. a severe allergic reaction (e.g., anaphylaxis) after a previous dose of tenivac or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of tenivac. [see description (11) .] because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no adequate and well-controlled studies of tenivac administration in pregnant women in t

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - temozolomide 250mg - capsule - 250 mg - active: temozolomide 250mg excipient: colloidal silicon dioxide gelatin lactose sodium laurilsulfate sodium starch glycolate stearic acid tartaric acid tekprint black sw-9008 tekprint black sw-9010 titanium dioxide

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - lapatinib ditosilate monohydrate 405mg equivalent to 250 mg lapatinib free base - tablet - 250 mg - active: lapatinib ditosilate monohydrate 405mg equivalent to 250 mg lapatinib free base excipient: magnesium stearate microcrystalline cellulose opadry yellow ys-1-12524-a povidone sodium starch glycolate - her2-positive (her2+) overexpressing metastatic breast cancer tykerb, in combination with capecitabine, is indicated for the treatment of patients with advanced/metastatic breast cancer whose tumours overexpress her2 (erbb2) and whose tumours have progressed after treatment with an anthracycline and a taxane, and who have progressed on prior trastuzumab therapy in the metastatic setting. tykerb, in combination with paclitaxel, is indicated for the first-line treatment of patients with metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom trastuzumab is not appropriate. hormone receptor-positive metastatic breast cancer tykerb, in combination with an aromatase inhibitor, is indicated for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress her2 (erbb2) and for whom hormonal therapy is indicated.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - abiraterone acetate 250mg - tablet - 250 mg - active: abiraterone acetate 250mg excipient: colloidal silicon dioxide croscarmellose sodium lactose magnesium stearate microcrystalline cellulose povidone sodium laurilsulfate - zytiga is indicated in combination with prednisone or prednisolone and androgen depreviation therapy (adt) for the treatment of high-risk metastatic hormone naive prostate cancer (mhnpc) or newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) zytiga is also indicated with prednisone or prednisolone for: . the treatment of patients with metastatic castration resistant prostate cancer (mcprc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) in whom chemotherapy is not yet clinically indicated . the treatment of patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcprc) who have received prior chemotherapy containing a taxane.

Singapore - English - HSA (Health Sciences Authority)

novartis (singapore) pte ltd - lapatinib ditosylate 405.0mg eqv lapatinib - tablet, film coated - 250.00mg - lapatinib ditosylate 405.0mg eqv lapatinib 250.00mg

Singapore - English - HSA (Health Sciences Authority)

pfizer private limited - azithromycin dihydrate eqv azithromycin - tablet, film coated - 250 mg - azithromycin dihydrate eqv azithromycin 250 mg

Canada - English - Health Canada

pharmascience inc - valproic acid (divalproex sodium) - tablet (enteric-coated) - 250mg - valproic acid (divalproex sodium) 250mg - miscellaneous anticonvulsants

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

lupin australia pty limited - levetiracetam, quantity: 250 mg - tablet, film coated - excipient ingredients: maize starch; colloidal anhydrous silica; croscarmellose sodium; povidone; microcrystalline cellulose; purified talc; magnesium stearate; titanium dioxide; macrogol 6000; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme). add-on therapy in the treatment of primary generalized tonic clonic (pgtc) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige).