দেশ: ফিলিপাইন
ভাষা: ইংরেজি
সূত্র: FDA (Food And Drug Administration)
Human Plasma Coagulation Factor VIII
N/A; Importer: New Marketlink Pharmaceutical Corporation; Distributor: Metro Drug Inc.
Human Plasma Coagulation Factor VIII
500 IU
Lyophilized Powder for Injection (IV)
Type I glass vial + 10 mL diluent (Water for Injection) in a box, Type I glass vial + 10mL diluent (Water for Injection) in a bo
Kedrion S.p.A, Italy
2022-10-06
_EMOCLOT- PIL-St.Eng-K17 _ _1 _ PACKAGE LEAFLET: INFORMATION FOR THE USER EMOCLOT 500 IU/10 ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION EMOCLOT 1000 IU/10 ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION HUMAN PLASMA COAGULATION FACTOR VIII READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET : 1. What EMOCLOT is and what it is used for 2. What you need to know before you use EMOCLOT 3. How to use EMOCLOT 4. Possible side effects 5. How to store EMOCLOT 6. Contents of the pack and other information 1. WHAT EMOCLOT IS AND WHAT IT IS USED FOR. EMOCLOT is a blood coagulation factor VIII solution derived from human plasma. Factor VIII is a protein which has an antihemorrhagic action. EMOCLOT is used for: treatment and prevention of bleeding in patients with a hereditary deficiency of factor VIII activity (haemophilia A); treatment of bleeding in patients with a factor VIII activity secondary to other diseases; treatment of haemophiliac patients who have developed antibodies against factor VIII (inhibitors) _EMOCLOT- PIL-St.Eng-K17 _ _2 _ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMOCLOT DO NOT USE EMOCLOT if you are allergic to human factor VIII or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using EMOCLOT _Allergic reaction _ Allergic type hypersensitivity reactions are possible with EMOCLOT. EMOCLOT contains traces of human proteins other than factor VIII. During the administration of the product if you notice any of the follow সম্পূর্ণ নথি পড়ুন
_This is a translation of the Italian Summary of Product Characteristics (SPC). _ _As not all the information given applies to your country, please refer to your local SPC._ _ _ _ 1 _ _ _ _ _ _EMOCLOT-SPC-StdEng-K17 _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EMOCLOT 500 IU/10 ml Powder and solvent for solution for infusion EMOCLOT 1000 IU/10 ml Powder and solvent for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human plasma coagulation Factor VIII, freeze dried. Each vial contains nominally 500 IU or 1000 IU of human coagulation factor VIII. EMOCLOT contains approximately 500 IU/10 ml or 1000 IU/ 10 ml of human coagulation factor VIII after reconstitution. EMOCLOT is presented as a powder and solvent for solution for infusion containing nominally: EMOCLOT 500 IU/10 ML EMOCLOT 1000 IU/10 ML human plasma coagulation factor VIII 500 IU/vial 1000 IU/vial human plasma coagulation factor VIII reconstituted with water for injections 50 IU/ ml (500 IU/10 ml) 100 IU/ ml (1000 IU/10 ml) solvent volume 10 ml 10 ml The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of EMOCLOT is approximately 80 IU/mg protein. Produced from the plasma of human donors. This preparation contains human von Willebrand factor. Excipient(s) with known effect: this medicinal product contains up to 41 mg sodium per vial of 10 ml. For a full list of excipients, see paragraph 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for solution for infusion. _This is a translation of the Italian Summary of Product Characteristics (SPC). _ _As not all the information given applies to your country, please refer to your local SPC._ _ _ _ 2 _ _ _ _ _ _EMOCLOT-SPC-StdEng-K17 _ The medicinal product is a white or pale yellow, hygroscopic powder or friable solid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor VIII deficiency). Management of acquired Factor VIII deficiency. Treatme সম্পূর্ণ নথি পড়ুন