Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Alpha-1-proteinase inhibitor, Quantity: 500 mg
Grifols Australia Pty Ltd
Liquid, multipurpose
Excipient Ingredients: monobasic sodium phosphate monohydrate; alanine; water for injections
Intravenous
one 10 mL vial in one carton
(S4) Prescription Only Medicine
PROLASTIN? C LIQUID is an Alpha-1-proteinase inhibitor indicated to increase serum Alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha-1- antitrypsin and with clinically significant emphysema (FEV1 <80%).,The data for clinical efficacy of PROLASTIN? C LIQUID is derived from changes in the biomarkers alpha-1 anti-protease level and CT lung density. Efficacy on FEV1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials.,Clinical trials have only included patients who were not smoking.
Visual Identification: The solution is clear or slightly opalescent, colourless or pale yellow or pale green or pale brown; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2022-05-27
PROLASTIN ® C LIQUID 1 Consumer Medicine Information PROLASTIN ® C LIQUID PROLASTIN C LIQUID Alpha-1-proteinase inhibitor (human) 500 mg solution for injection for intravenous infusion vial PROLASTIN C LIQUID Alpha-1-proteinase inhibitor (human) 1000 mg solution for injection for intravenous infusion vial PROLASTIN C LIQUID Alpha-1-proteinase inhibitor (human) 4000 mg solution for injection for intravenous infusion vial WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using PROLASTIN ® C (prō-‘lǎs-tĭn) LIQUID. This leaflet answers some common questions about PROLASTIN ® C LIQUID, a prescription medicine. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you using PROLASTIN ® C LIQUID against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR. Keep this leaflet with you. You may need to read it again. WHAT PROLASTIN ® C LIQUID IS USED FOR PROLASTIN ® C LIQUID is used to treat Alpha-1-proteinase inhibitor deficiency. This is a genetic disorder. It is characterised by very low amounts of your own Alpha-1- proteinase inhibitor protein in your lungs. Some patients develop a serious lung disease called emphysema. PROLASTIN ® C LIQUID contains human Alpha-1-proteinase inhibitor manufactured from blood products. You take PROLASTIN ® C LIQUID to boost Alpha-1-proteinase inhibitor in your bloodstream and lungs. One of the reasons your lungs have been damaged is because you lack enough of Alpha-1-proteinase inhibitor. Other causes include smoking and infections. Alpha-1- PROLASTIN ® C LIQUID 2 proteinase inhibitor inhibits enzymes that break down lung tissue. Be aware that there are no medical studies in people to prove that taking PROLASTIN ® C LIQUID over a long period of time will stop or slow down the symptoms of emphysema. BEFORE YOU USE PROLASTIN ® C LIQUID _WHEN YOU MUST NOT USE IT_ Lesen Sie das vollständige Dokument
PROLASTIN ® C LIQUID Alpha-1-proteinase inhibitor Page 1 of 13 Product Information AUSTRALIAN PRODUCT INFORMATION PROLASTIN ® C LIQUID (Alpha-1-proteinase inhibitor) Solution for Injection for Intravenous Infusion Vial 1 NAME OF THE MEDICINE Alpha-1-proteinase inhibitor (human) 500 mg solution for injection for intravenous infusion vial Alpha-1-proteinase inhibitor (human) 1000 mg solution for injection for intravenous infusion vial Alpha-1-proteinase inhibitor (human) 4000 mg solution for injection for intravenous infusion vial 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PROLASTIN ® C LIQUID has a purity of ≥ 90% Alpha-1-proteinase inhibitor. Each single-use vial contains approximately 500 mg (10 mL), 1,000 mg (20 mL), and 4,000 mg (80 mL) of functionally active Alpha-1-proteinase inhibitor as determined by capacity to neutralise porcine pancreatic elastase. PROLASTIN ® C LIQUID is prepared from pooled human plasma collected from donors in the USA. PROLASTIN ® C LIQUID contains no preservative. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM PROLASTIN ® C LIQUID is a sterile non-pyrogenic solution for injection for intravenous infusion of Alpha-1-proteinase inhibitor. The solution is clear or slightly opalescent, colourless or pale yellow or pale green or pale brown. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROLASTIN ® C LIQUID is an Alpha-1-proteinase inhibitor indicated to increase serum Alpha-1-proteinase inhibitor levels in adults with congenital deficiency of alpha- 1-antitrypsin and with clinically significant emphysema (FEV 1 <80%). The data for clinical efficacy of PROLASTIN ® C LIQUID is derived from changes in the biomarkers alpha-1 anti-protease level and CT lung density. Efficacy on FEV 1 or patient relevant endpoints such as quality of life or pulmonary exacerbations has not been established in randomised clinical trials. Clinical trials have only included patients who were not smoking. 4.2 DOSE AND METHOD OF ADMINISTRATION FOR INTRAVENOU Lesen Sie das vollständige Dokument