Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
human thrombin, Quantity: 4000 IU
Johnson & Johnson Medical Pty Ltd
Factor XIII,Fibrinogen,human thrombin
Solution
Excipient Ingredients: mannitol; calcium chloride dihydrate; water for injections; sodium acetate; Albumin; tributyl phosphate; octoxinol 9
Epilesional Introduced onto or around a localised lesion
10mL (5mL thrombin solution + 5 mL fibrinogen solution)
exempt from scheduling - Appendix A; prescription medicine
? as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. ? as suture support for haemostasis in large vessel vascular surgery. ? for suture line sealing in dura mater closure.
Visual Identification: Clear or slightly opalescent solutions; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze)
Registered
2012-10-22
CONSUMER MEDICINE INFORMATION EVICEL ® Solutions for Fibrin Sealant (Human Thrombin, Human Fibrinogen and Factor XIII) WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about EVICEL® Solutions for Fibrin Sealant. 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 EVICEL® Solutions for Fibrin Sealant. 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. Read this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. WHAT IS EVICEL® AND WHAT IS IT USED FOR? EVICEL® is a Fibrin Sealant which is supplied in Australia as a package containing two separate vials, each containing 1 mL, 2 mL or 5 mL of solution Human Fibrinogen and Human Thrombin, respectively. An application device and appropriate accessory tips are supplied separately. EVICEL® is applied during surgical operations to reduce bleeding and oozing during and after the operation. EVICEL® is also used to seal tissues during neurosurgery. It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and/or stops bleeding. EVICEL® can also be used in blood vessel surgery, in surgery taking place in the area between the bowels and the posterior abdominal wall, and in brain surgery. HOW DOES EVICEL® WORK? Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce. Thus, when the two components are mixed together they clot instantly. BEFORE YOU ARE GIVEN THE EVICEL® EVICEL® SHOULD NOT BE GIVEN TO YOU IF • You are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL®. Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and breathing difficulties. If these symptoms occur, the administration Read the complete document
1 20210317 AUSTRALIAN PRODUCT INFORMATION – EVICEL ® SOLUTIONS FOR FIBRIN SEALANT (HUMAN THROMBIN, HUMAN FIBRINOGEN AND, FACTOR XIII) 1 NAME OF THE MEDICINE Human Thrombin, Human Fibrinogen and Factor XIII. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Fibrinogen Solution _– 1mL contains Fibrinogen 80 to 120 mg/mL total protein (clottable protein (human) 50 – 90 mg). _Thrombin Solution_ – 1mL contains 800 to 1,200 IU Thrombin (human) _ _ _Note._ 1 IU (international unit) Thrombin (human) is defined as the activity contained in 0.0853mg of the first international standard of human thrombin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solutions for fibrin sealant. The Fibrinogen and Thrombin solutions appear as white to slightly yellowish opaque masses when frozen, and as clear to slightly opalescent and colourless to slightly yellowish solutions when thawed. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS EVICEL ® is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis. EVICEL ® is also indicated as suture support for haemostasis in large vessel vascular surgery. EVICEL ® is indicated for suture line sealing in dura mater closure. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The volume of EVICEL ® to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient. The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications. 2 20210317 Application of the product must be individualised by the treating physician. In controlled clinical trials in vascular surgery the individual dosage used was up to 4 mL. For dural sealing in neurosurgery, doses of up to 8 mL were used, whereas in retroperitoneal or intra-abdominal surgery the individual dosage used was up to 10 mL. For some procedures ( Read the complete document