Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
water for injections, Quantity: 40 mL
CSL Behring Australia Pty Ltd
Factor II,Factor IX,Factor VII,Factor X,Protein C,Protein S,water for injections
Injection, solution
Excipient Ingredients:
Intravenous
Single vial: 1 x 1000
Not scheduled. Not considered by committee
Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
Visual Identification: Clear, colourless fluid; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-08-05
Beriplex P/N AU CMI 6.00 Page 1 of 4 BERIPLEX ® P/N Human prothrombin complex CONSUMER MEDICINE INFORMATION 250 IU: AUST R 156330 500 IU: AUST R 156459 1000 IU: AUST R 228338 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Beriplex ® P/N. The leaflet does not contain all the available information. It does not take the place of talking to your doctor. All medicines have benefits and risks. Your doctor has weighed the benefits that Beriplex ® P/N will have for you against the risks. If you have any concerns about taking this medicine, ask your doctor. Follow your doctor’s advice even if it is different from what this leaflet says. Keep this leaflet with the medicine. You may need to read it again. The information in this leaflet is subject to change. Please check with your doctor whether there is any new information about this medicine that you should know since you were last treated with this medicine. WHAT BERIPLEX ® P/N IS USED FOR Beriplex ® P/N is used to treat bleeding conditions that may be caused when you are taking a blood thinner (e.g. warfarin) and unexpected bleeding occurs. The coagulation factors called factor II, factor VII, factor IX and factor X together make up the prothrombin complex. The factors are made in the liver when your body has enough vitamin K. Medicines, like warfarin, which are used to thin the blood (also called vitamin K antagonists, or anticoagulants) prevent blood clotting and may work by stopping the liver from making coagulation factors. If you do not have enough vitamin K, or you have been treated with medicines which are used to thin the blood, you may be at risk of bleeding and haemorrhage. Ask your doctor if you have any questions about why Beriplex ® P/N has been prescribed for you. HOW BERIPLEX ® P/N WORKS Beriplex ® P/N works by replacing the coagulation (clotting) factors your body needs. Beriplex ® P/N belongs to a group of medicines called prothrombin complex products, which are made from human blood. BEFORE YOU ARE GIVEN BERIPLEX ® Pročitajte cijeli dokument
Beriplex P/N AU PI 6.00 Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION BERIPLEX ® P/N (HUMAN PROTHROMBIN COMPLEX) 1 NAME OF THE MEDICINE Human prothrombin complex 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Beriplex ® P/N is presented as a powder, containing human prothrombin complex, in packs of 250 IU, 500 IU and 1000 IU factor IX, for reconstitution with a vial of diluent. P/N refers to the virus inactivation and removal steps of pasteurisation and nanofiltration (virus filtration). The product contains the following IU of the human coagulation factors in TABLE 1. TABLE 1: ACTIVE INGREDIENT COMPOSITION NAME OF THE INGREDIENTS CONTENT AFTER RECONSTITUTION (IU/ML) BERIPLEX ® P/N 250 CONTENT PER VIAL (IU) BERIPLEX ® P/N 500 CONTENT PER VIAL (IU) BERIPLEX ® P/N 1000 CONTENT PER VIAL (IU) ACTIVE INGREDIENTS Human coagulation factor II 20–48 200–480 400–960 800–1920 Human coagulation factor VII 10–25 100–250 200–500 400–1000 Human coagulation factor IX 20–31 200–310 400–620 800–1240 Human coagulation factor X 22–60 220–600 440–1200 880–2400 OTHER ACTIVE INGREDIENTS Protein C 15–45 150–450 300–900 600–1800 Protein S 12–38 120–380 240–760 480–1520 The total protein content is 6–14 mg/mL of reconstituted solution. Beriplex P/N AU PI 6.00 Page 2 of 22 The specific activity of factor IX is 2.5 IU per mg total protein. The activities of all coagulation factors as well as protein C and S (antigen) have been tested according to the current valid international WHO Standards. Beriplex ® P/N contains up to 343 mg sodium (approximately 15 mmol) and up to 200 IU heparin per 100 mL reconstituted solution. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Powder and diluent for solution for injection Powder: white or slightly coloured powder or friable solid Diluent (Water for Injections): clear, colourless. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment and perioperative prophylaxis of bleedings in acquired deficiency of th Pročitajte cijeli dokument