Bandaríkin - enska - NLM (National Library of Medicine)

wyeth biopharma division of wyeth pharmaceuticals llc - moroctocog alfa (unii: 113e3z3cjj) (moroctocog alfa - unii:113e3z3cjj) - 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 no information regarding the presence of xyntha in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for xyntha and any potential adverse effects on the breastfed child from xyntha or from the underlying maternal condition. safety and efficacy with xyntha were evaluated in clinical studies in 68 pediatric subjects <17 years of age (18 subjects aged 12 to <17 years, 50 subjects aged ≤12 years). there were no apparent differences in the efficacy and safety in pediatric subjects as compared to adults [see adverse reactions (6.1) and clinical studies (14) ]. in comparison to the pharmacokinetic parameters reported in adults, children have shorter half-lives, larger volumes of distribution and lower recovery of factor viii after xyntha administration. the clearance (based on per kg body weight) is approximately 40% higher in children. higher or more frequent doses may be required to account for the observed differences in pharmacokinetic parameters [see clinical pharmacology (12.3) ]. clinical studies of xyntha did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. xyntha ® /zin -tha/ [antihemophilic factor (recombinant)] xyntha is supplied as a lyophilized powder. before you can infuse it (intravenous injection), you must reconstitute the powder by mixing it with the liquid diluent supplied. the liquid diluent is 0.9% sodium chloride. reconstitute and infuse xyntha using the infusion set, diluent, syringe, and adapter provided in this kit. please follow the directions below for the proper use of this product. preparation and reconstitution of xyntha preparation reconstitution note: if you use more than one vial of xyntha for each infusion, reconstitute each vial according to steps 1 through 11. note: infusion of xyntha your healthcare provider will teach you how to infuse xyntha yourself. once you learn how to do this, you can follow the instructions in this insert. before xyntha can be infused, you must reconstitute it as instructed above in the preparation and reconstitution of xyntha section. after reconstitution, be sure to look carefully at the xyntha solution. the solution should be clear to slightly opalescent and colorless. if it is not, throw away the solution and use a new kit. use the infusion set included in the kit to infuse xyntha. do not infuse xyntha in the same tubing or container with other medicines. note: additional instructions xyntha is also supplied in kits that have both the xyntha powder and the diluent within single-use prefilled dual-chamber syringes, called xyntha solofuse. if you use one xyntha vial and one of xyntha solofuse for the infusion, reconstitute the xyntha vial and the xyntha solofuse according to the specific directions for that respective product kit. use a separate 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of the xyntha vial and xyntha solofuse. use of a xyntha vial kit with a xyntha solofuse kit these instructions are for the use of only one xyntha vial kit and one xyntha solofuse kit. for further information, please contact your healthcare provider or call the medical information department at wyeth pharmaceuticals, 1-800-438-1985. note: dispose of all unused solution and other used medical supplies in an appropriate container. this product's labeling may have been updated. for the most recent prescribing information, please visit www.pfizer.com . license no: 3 lab-0516-9.0

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - octocog alfa; recombinant coagulation factor viii -

Ísrael - enska - Ministry of Health

pfizer pharmaceuticals israel ltd - moroctocog alfa - lyophilized powder for injection - moroctocog alfa 250 iu/vial - treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency)

Bandaríkin - enska - NLM (National Library of Medicine)

cangene biopharma - coagulation factor ix recombinant human (unii: 382l14738l) (coagulation factor ix recombinant human - unii:382l14738l) - coagulation factor ix recombinant human 500 [iu] in 5 ml

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 2000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 3000 iu - injection, diluent for - excipient ingredients: water for injections - kogenate fs is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. kogenate fs does not contain von willebrand factor and hence is not indicated in von willebrands disease.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 1000 iu - diluent, not applicable - excipient ingredients: water for injections - for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. these products do not contain von willebrand factor, and hence are not indicated in von willebrand's disease.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 250 iu - diluent, not applicable - excipient ingredients: water for injections - indications: for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency).it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. these products do not contain von willebrand factor, and hence are not indicated in von willebrand's disease.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - octocog alfa, quantity: 500 iu - diluent, not applicable - excipient ingredients: water for injections - indications: for the treatment and prophylaxis of bleeding in patients with haemophilia a (congenital factor viii deficiency). it may also be used in patients with factor viii inhibitors (neutralising antibodies) who continue to respond to infused factor viii. these products do not contain von willebrand factor, and hence are not indicated in von willebrand's disease.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

mediflex industries pty ltd - 61694 - skin-cleaning wipe, non-sterile - a non-sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) intended for cleaning and/or to maintain skin hygiene