Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Streptokinase 250000 [iU]
Seqirus (NZ) Ltd
Streptokinase 250000 IU
250000 IU
Powder for injection
Active: Streptokinase 250000 [iU] Excipient: Albumin Monosodium glutamate Polygeline
Vial, single dose, 1 dose unit
Prescription
Prescription
CSL Behring GmbH
Package - Contents - Shelf Life: Vial, single dose, - 1 dose units - 48 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1969-12-31
Page 1 STREPTASE (strep-tays) streptokinase (strep-toe-kine-ays) Consumer Medicine Information (CMI) What is in this leaflet This leaflet answers some common questions about Streptase. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Streptase against the benefits they expect it will have for you. If you have any concer ns about being given this medicine, ask your doctor or phar macist. Keep this leaflet with the medicine. You may need to read it again. What Streptase is used for The active ingredient of Streptase is streptokinase, an enzyme produced by streptococcus bacteria. Streptase is used in hospitals to dissolve blood clots, especially those in the heart and lungs. It is also used on the clots formed in the tubing during kidney dialysis. Your doctor may have prescribed Streptase for another reason. Ask your doctor if you have any questions about why Str eptase has been pr escr ibed for you. This medicine is available only with a doctor’s prescription. Streptase is not recommended for use in children. Before you are given it When you must not be given it You must not r eceive Str eptase if: • you have a severe allergy to Streptase or an allergy to any of the ingredients listed at the end of this leaflet • you are bleeding • you have received streptokinase more than 5 days ago and less than 12 months ago • any of the following apply to you: - recent haemorrhage, biopsy or surgery of any kind - peptic ulcer, ulcerative colitis (inflammation of the colon) or diverticulitis (inflammation in the colon) - Přečtěte si celý dokument
DATA SHEET STREPTASE ® _STREPTOKINASE _ DESCRIPTION Streptase is highly purified streptokinase obtained from the culture filtrate of beta- haemolytic streptococci of group C. The various strengths of Streptase contain the following amounts of dry substance including pure lyophilised streptokinase and human albumin as stabilising agent: 250 000 IU streptokinase: 134 - 176 mg dried material 750 000 IU streptokinase: 139 - 182 mg dried material 1 500 000 IU streptokinase: 147 - 192 mg dried material PHARMACOLOGY Streptokinase acts with plasminogen to produce an 'activator complex' that converts plasminogen to the proteolytic enzyme, plasmin. The more plasminogen bound within this complex, the less plasminogen is left to be converted into its enzymatically active form. Therefore, high doses of streptokinase are associated with a lower bleeding risk and low doses of streptokinase are associated with a higher bleeding risk. Due to the high degree of affinity and rapid reaction between streptokinase and antistreptokinase-antibodies, which are possibly present in the patient's blood, low quantities of streptokinase are eliminated from the blood with a half-life of 18 minutes. The elimination half-life of streptokinase based on activator formation is about 80 minutes. The major part of streptokinase is degraded to peptides and eliminated by the intestines and kidneys. Plasmin degrades fibrin clots as well as fibrinogen and other plasma proteins. Plasmin is inactivated by circulating inhibitors such as alpha-2-plasmin inhibitor or alpha-2-macroglobulin. These inhibitors are rapidly consumed at high doses of streptokinase. Experimental studies have shown that Streptase induces lysis of the thrombus both superficially and also from within the thrombus. Intravenous infusion of streptokinase is followed by increased fibrinolytic activity, which decreases plasma fibrinogen levels for 24 to 36 hours. The decrease in plasma fibrinogen is associated with decrease Přečtěte si celý dokument