Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
human thrombin, Quantity: 500 IU/mL
Grifols Australia Pty Ltd
Application
Excipient Ingredients:
Epilesional Introduced onto or around a localised lesion
The pack sizes are 2 mL, 4 mL, 6 mL, 10 mL (total volume)
exempt from scheduling - Appendix A; prescription medicine
VeraSeal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.
Visual Identification: clear or slightly opalescent and colourless or pale yellow; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below minus 18 degrees Celsius (deep freeze)
Registered
2021-11-03
VeraSeal TM 1 VERASEAL TM CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. This medicine is new or being used differently. Please report side effects. See the full CMI for further details. WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine. 1. WHY AM I USING VERASEAL? VeraSeal contains the active ingredients human fibrinogen and human thrombin. VeraSeal is used as a sealant during surgical operations in adults. It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not enough. For more information, see Section 1. Why am I using VeraSeal? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM TREATED WITH VERASEAL? Do not use if you have ever had an allergic reaction to VeraSeal or any of the ingredients listed at the end of the CMI. VeraSeal must not be applied inside blood vessels. VeraSeal must not be used to treat severe or rapid bleeding from an artery. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I am treated with VeraSeal? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VeraSeal and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW IS VERASEAL USED? • Your surgeon will decide how much VeraSeal is needed. Your surgeon will apply an amount of VeraSeal that is just enough to form a thin, even layer.Detailed instruccions for your surgeon or nurse on how to prepare VeraSeal are included in the Product Information. More instructions can be found in Section 4. How is VeraSeal used? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING VERASEAL? For more information, s Baca dokumen lengkapnya
1 ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION VERASEAL ™ SOLUTIONS FOR SEALANT (HUMAN FIBRINOGEN, HUMAN THROMBIN) WARNINGS • Life-threatening thromboembolic complications may occur if VeraSeal is administered intravascularly (see section 4.4.). • VeraSeal is made from pooled human plasma which may contain infectious agents, such as viruses, that can cause disease (see section 4.4.). 1 NAME OF THE MEDICINE Human fibrinogen, Human thrombin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Human fibrinogen 80 mg/mL Component 2: Human thrombin 500 IU/mL For the full list of excipients, see Section 6.1 List of excipients. VeraSeal is a two-component fibrin sealant made of frozen sterile solutions of human fibrinogen and human thrombin produced from the plasma of human donors. Cohn’s plasma fractionation method is used to obtain Fraction I, which is the starting material for the production of fibrinogen, and the prothrombin complex isolated from supernatant of Fraction I, which is the starting material for the production of thrombin. The purification process of fibrinogen includes solvent/detergent treatment, three glycine precipitation steps, and double nanofiltration using 35-nm and 20-nm filters. The purification process of thrombin includes solvent/detergent treatment, ion exchange chromatography, and double nanofiltration through 15-nm filters. After nanofiltration, the fibrinogen and thrombin solutions are formulated, sterile filtered, aseptically filled in syringes, packaged, sterilized, and frozen. 2 3 PHARMACEUTICAL FORM Solutions for sealant. Frozen solutions. After thawing, the solutions are clear or slightly opalescent and colourless or pale yellow. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS VeraSeal is used as supportive treatment in adults where s Baca dokumen lengkapnya