Israel - English - Ministry of Health

csl behring ltd., israel - human fibrinogen - powder for solution for inj/inf - human fibrinogen 1800 - 2600 mg / 1 vials - fibrinogen, human - fibrinogen, human - haemocomplettan p 1g/2g, fibrinogen concentrate (human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.haemocomplettan p 1g/2g is not indicated for dysfibrinogenemia.

Malta - English - Medicines Authority

bio products laboratory limited dagger lane, elstree hertfordshire, wd6 3bx, united kingdom - immunoglobulin rabies, human - solution for injection - immunoglobulin rabies, human 150 iu/ml - immune sera and immunoglobulins

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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 250 iu; human immunoglobulin g, quantity: 160 mg/ml - injection, solution - excipient ingredients: glycine; human immunoglobulin a - tetanus immunoglobulin is indicated for the passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. it should also be given to the fully immunised patient with a tetanus-prone wound if more than 10 years have elapsed since the last dose of toxoid. in all the above instances, active immunisation with tetanus toxoid, adsorbed or adt vaccine should be commenced at the same time [in accordance with details specified in table 1 (guide to tetanus prophylaxis in wound management) in indication section of the approved product information provided as attachment 1]. although tetanus immunoglobulin and vaccine should be given at the same time, they should be administered in opposite limbs, using separate syringes.

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

csl behring australia pty ltd - tetanus immunoglobulin, quantity: 4000 iu; human immunoglobulin g, quantity: 50 mg/ml - injection, intravenous infusion - excipient ingredients: maltose; water for injections; human immunoglobulin a - tetanus immunoglobulin-vf (for intravenous use) is used in the management of clinical tetanus.

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 200 g/l - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 50 g/l - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 200 g/l - blood substitutes and perfusion solutions

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. human albumin grifols® 20% can be used in such cases.1 human albumin grifols 20% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 human albumin grifols 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 human albumin grifols 20% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when albumin deficit is the result of excessive protein loss, the effect of human albumin grifols 20% administration will be temporary unless the underlying disorder is reversed.8,9,10 septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 treatment with human albumin grifols 20% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1 in the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. beyond 24 hours, human albumin grifols 20% can be used to maintain plasma colloid osmotic pressure.2,12,13 protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15 human albumin grifols 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17 human albumin grifols 20% is indicated for the treatment of neonatal hyperbilirubinemia. it may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20 human albumin grifols 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ards.6,21 human albumin grifols 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24 - hypersensitivity to albumin preparations or to any of the excipients. - severe anemia or cardiac failure with normal or increased intravascular volume. pregnancy category c. animal reproduction studies have not been conducted with human albumin grifols 20%. it is also not known whether human albumin grifols 20% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. human albumin grifols 20% should be given to a pregnant woman only if clearly needed. no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed.

Israel - English - Ministry of Health

cts ltd - human fibrinogen; thrombin - sealant matrix - thrombin 2 iu/cm2; human fibrinogen 5.5 mg/cm2 - human fibrinogen - human fibrinogen - tachosil is indicated for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for sutute support in vascular surgery where standard techniques are insufficient.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - human albumin - solution for injection - 10/50 %v/v