Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
normal immunoglobulin, Quantity: 100 mg/mL
Takeda Pharmaceuticals Australia Pty Ltd
normal immunoglobulin
Injection, solution
Excipient Ingredients: glycine; water for injections; normal immunoglobulin
Intravenous, Subcutaneous
1 x 200mL vial
(S4) Prescription Only Medicine
KIOVIG administered intravenously is indicated for:,1. Replacement therapy indications,? Primary immunodeficiency disorders (PID);,? Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.,2. Immunomodulation indications,? Idiopathic thrombocytopenia purpura (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count;,? Guillain Barr? Syndrome;,? Kawasaki Disease;,? Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in adults.,? Multifocal Motor Neuropathy (MMN).,KIOVIG administered subcutaneously is indicated for:,1. Replacement therapy indications,? Primary immunodeficiency disorders (PID).
Visual Identification: The solution should be relatively clear with a slight opalescense.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2008-09-02
KIOVIG _Normal Immunoglobulin (Human)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about the KIOVIG. It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks against the benefits for you by using KIOVIG. It does not take the place of talking to your doctor or pharmacist. If you have any concerns about having this medicine, ask your doctor or pharmacist. Please read this leaflet carefully and keep it for future reference. Please also note that this leaflet is subjected to change, therefore, ask your doctor whether this is the latest information regarding this medicine. WHAT KIOVIG IS USED FOR KIOVIG is used for: TREATMENT OF PATIENTS WHO DO NOT HAVE SUFFICIENT ANTIBODIES (REPLACEMENT THERAPY): - Primary immunodeficiency disorders - Disease or medical treatment that leads to a lack of antibody production and frequent infection (secondary hypogammaglobulinaemia). TREATMENT OF PATIENTS WITH CERTAIN INFLAMMATORY DISORDERS (IMMUNOMODULATION): - Idiopathic thrombocytopenic purpura (ITP, a disease where patients do not have enough blood platelets), who are at high risk of bleeding or prior to surgery to correct the platelet count. - Guillain Barré syndrome (a disease with multiple inflammations of the nervous system of the whole body) - Kawasaki disease (a disease which results in multiple inflammations of several organs) - Multifocal motor neuropathy HOW DOES KIOVIG WORK KIOVIG belongs to a class of medicines called immunoglobulins. These medicines contain human antibodies, which are also present in your blood. Antibodies help your body to fight infections. Immunoglobulins are used in patients who do not have enough antibodies in their blood and tend to get frequent infections. They can also be used in patients who need additional antibodies for the treatment of certain inflammatory disorders. The active component in KIOVIG, immunoglobulin, is isolated from the plasma of human donors. As required Olvassa el a teljes dokumentumot
KIOVIG PI V3.0 (CCDS v1.0) 1 AUSTRALIAN PRODUCT INFORMATION KIOVIG ® (NORMAL IMMUNOGLOBULIN (HUMAN)) 1 NAME OF THE MEDICINE Normal Immunoglobulin (Human). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION KIOVIG vials contain 1.0 g in 10 mL, 2.5 g in 25 mL, 5.0 g in 50 mL, 10.0 g in 100 mL, 20.0 g in 200 mL or 30.0 g in 300 mL of the active normal immunoglobulin (Human) [Immunoglobulin G (IgG) 100 mg/mL]. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. DESCRIPTION The active ingredient in KIOVIG is a human plasma-derived immunoglobulin, concentration of 100 mg/mL (10% w/v), produced from large pools of human plasma by a modified Cohn- Oncley cold ethanol fractionation, yielding an intermediate immunoglobulin G (IgG), referred to as Precipitate G. During the cold ethanol plasma fractionation manufacturing process, the level of viral burden in a plasma pool has been largely reduced to a certain extent, as demonstrated by viral spiking experiment. Precipitate G is further purified by means of a weak cation-exchange and anion-exchange chromatography. To reduce further a possible viral transmission to a minimal level, a triple step of viral inactivation (TVR inactivation), [solvent detergent (S/D), nano-filtration (35nm), and incubation at a low pH and elevated temperature (30ºC to 32 ºC, pasteurisation for 21 to 23 days) has been incorporated into the downstream purification. Thus, the active ingredient formulated in KIOVIG has been subjected to a rigorous elimination for both lipid and non- lipid enveloped viruses. The manufacturing processes do not affect the composition of the immunoglobulin in the normal human plasma origin. The distribution of the IgG sub-classes formulated in this product comprises IgG1 ≥ 56.9%, IgG2 ≥ 26.6 %, IgG3 ≥ 3.4%, and IgG4 ≥ 1.7%. It contains immunoglobulin A (IgA) at a trace level, which is not more than 0.14 mg/mL. The preparation is a sterile, nonpyrogenic, isotonic solution with osmolality of 240 to 300 mOsmol/kg and a pH of 4.6 to 5.1. At this low pH the f Olvassa el a teljes dokumentumot