CSL Product Number 32800192 Product Name PROTHROMBINEX-VF 500IU Product Description Human Prothrombin Complex, powder for injection Each vial nominally contains approx. 500IU of Factor IX, approx. Product Concentration 500IU of Factor II and approx. 500IU of Factor X Kit Items (if applicable) One 20mL vial of Water for Injections and one Mix2Vial filter transfer set ARTG Number AUST R 124381 Approved Indications Treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex 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. Treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor IX, II or X when purified specific coagulation factor product is not available. Shelf Life (months) 24 Store at 2° - 8°C (Refrigerate. Do not freeze). Prothrombinex-VF Storage Conditions can be stored below 25°C for a single period of 6 months. The product must not be returned to refrigeration after storage below 25°C . Protect from light. Planned Product Changes [Not disclosed specifies planned product changes ] – Ability for a Party to remove [Not disclosed specifies when products may be removed from – the Product from supply supply under the Deed] under the Deed Ability for a Party to add the [Not disclosed specifies when products may be added to – Product to supply under the supply under the Deed] Deed CSL Product Number 32200194 Product Name THROMBOTROL-VF 1000IU Product Description Human Antithrombin III Concentrate (ATIII), for intravenous administration
CSL Product Number 32800192 Product Name PROTHROMBINEX-VF 500IU Product Description Human Prothrombin Complex, powder for injection Product Concentration Each vial nominally contains approx. 500IU of Factor IX, approx. 500IU of Factor II and approx. 500IU of Factor X Kit Items (if applicable) One 20mL vial of Water for Injections and one Mix2Vial filter transfer set ARTG Number AUST R 124381 Approved Indications Treatment and perioperative prophylaxis of bleeding in acquired deficiency of prothrombin complex 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. Treatment and prophylaxis of bleeding in patients with single or multiple congenital deficiency of factor IX, II or X when purified specific coagulation factor product is not available. Shelf Life (months) 24 Storage Conditions Store at 2° - 8°C (Refrigerate. Do not freeze). Prothrombinex-VF can be stored below 25°C for a single period of 6 months. The product must not be returned to refrigeration after storage below 25°C . Protect from light. Planned Product Changes [Not disclosed – specifies planned product changes ] Ability for a Party to remove the Product from supply under the Deed [Not disclosed – specifies when products may be removed from supply under the Deed] Ability for a Party to add the Product to supply under the Deed [Not disclosed – specifies when products may be added to supply under the Deed] CSL Product Number 32200194 Product Name THROMBOTROL-VF 1000IU Product Description Human Antithrombin III Concentrate (ATIII), for intravenous administration