国: イスラエル
言語: 英語
ソース: Ministry of Health
ALPHA-1-ANTITRYPSIN ( AAT)
KAMADA LTD, ISRAEL
B02AB02
SOLUTION FOR INFUSION
ALPHA-1-ANTITRYPSIN ( AAT) 1 G / 50 ML
I.V
Required
KAMADA LTD, ISRAEL
ALFA1 ANTITRYPSIN
Alpha1-Proteinase Inhibitor (Human), GLASSIA® is indicated for chronic augmentation and maintenance therapy in individuals with congenital deficiency of alpha1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin (AAT) deficiency and clinical evidence of emphysema.
2016-07-31
העדוה העדוה לע לע הרמחה הרמחה ( ( עדימ עדימ ןולעב )תוחיטב ןולעב )תוחיטב ל ל אפור אפור ןכדועמ( ןכדועמ( 05.2013 05.2013 ) ) ךיראת _______________ 13-07-2014 ________ םש רישכת תילגנאב רפסמו םושירה _ GLASSIA 146-60-33208 ______ םש לעב םושירה _________ KAMADA LTD ______________________________ דבלב תורמחהה טורפל דעוימ הז ספוט ! תורמחהה תושקובמה קרפ ןולעב טסקט יחכונ טסקט שדח DOSAGE AND ADMINISTRATION ADMINISTRATION Administer GLASSIA ® at room temperature through an appropriate intravenous administration set at a rate not greater than 0.04 mL/kg body weight per minute.The recommended dosage of 60 mg/kg takes approximately 60-80 minutes to infuse. You may then resume the infusion at a rate tolerated by the patient . ADMINISTRATION Administer GLASSIA ® at room temperature through an appropriate intravenous administration set at a rate not to exceed 0.2 mL/kg body weight per minute, and as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg at a rate of 0.2 mL/kg/min will take approximately 15 minutes to infuse. Resume the infusion at a rate tolerated by the patient, except in the case of severe reaction. WARNINGS AND PRECAUTIONS IF ANAPHYLACTIC OR SEVERE ANAPHYLACTOID REACTIONS OCCUR, DISCONTINUE THE INFUSION IMMEDIATELY. Discontinue the infusion if hypersensitivity symptoms occur and administer appropriate emergency treatment. TRANSMISSIBLE INFECTIOUS AGENTS Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. There is also the possibility that unknown infectious agents may be present in such products . The physician should weigh the risks and benefits of the use of this product and discuss the risks and benefits with the patient. Because this product is made from human plas 完全なドキュメントを読む
GLASSIA ® FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT GLASSIA ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alpha-1-antitrypsin (AAT) 1 g/50 ml _ _ _Excipient with known effect: _ _ _ Sodium Content : This medicinal product contains about 200mg sodium per bottle of 50 ml, equivalent to 10 % of the WHO recommended maximum daily intake of 2 g sodium for adult. For the full list of excipients, see section 14. 3. PHARMACEUTICAL FORM Solution for infusion 4. INDICATIONS AND USAGE Alpha 1 -Proteinase Inhibitor (Human), GLASSIA is indicated for chronic augmentation and maintenance therapy in individuals with congenital deficiency of alpha 1 -proteinase inhibitor (Alpha 1 -PI), also known as alpha 1 -antitrypsin (AAT) deficiency and clinical evidence of emphysema. • The effect of augmentation therapy with GLASSIA or any Alpha 1 -PI product on pulmonary exacerbations and on the progression of emphysema in Alpha 1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. • Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA are not available. • GLASSIA is not indicated as therapy for lung disease in patients in whom severe Alpha 1 - PI deficiency has not been established. 5 DOSAGE AND ADMINISTRATION For intravenous use only. 5.1 Dosage • Administer 60 mg/kg body weight of GLASSIA once weekly by intravenous infusion. • Dose ranging studies using efficacy endpoints have not been performed. 5.2 Preparation 1. Use aseptic technique. 2. Allow the product to reach room temperature prior to infusing and administer within three hours of entering the vials. 3. Inspect the vial of GLASSIA. The solution should be clear and colorless to yellow-green and may contain a few protein particles. Discard if the product is cloudy. 4. The product is suitable for infusion directly from the vial or pooled into an empty sterile container for intravenous infusion. 5. Use a vented spike (not supplied) to wit 完全なドキュメントを読む