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5980367 (03/2013

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KEEP LIFE FLOWING

PRODUCT CATALOGUE
KEEP LIFE FLOWING

KEDRION S.p.A.

55051 Castelvecchio Pascoli (LUCCA)
E-mail: marketing@kedrion.com
Tel: +39 0583 1969697
Fax: +39 0583 1969666
operator +39 0583 19691

www.kedrion.com

Member of

Plasma Protein Therapeutics Association

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liberty and security of person. activates and makes it possible to use the vital energy that is generated. of different companies operating in the sector and it acquired a heritage of expertise that secures it a prominent role in Italy.kedrion. Kedrion contributes to transforming natural right (life. natural. Kedrion stands out for its great attention to the international horizon and for the promotion of the local community. which took place in 2001. health and institutional communities. it gathers. VALUES Kedrion declares that: • social responsibility is the guiding principle of the company’s activities • transparency and full information are central to its relationships with stakeholders • trust in the company and within it is constantly fostered by activities that are competent. It works to consolidate its role as the spokesperson acknowledged by the medical. 2 3 . honest and informed Its attention to and respect for people takes real form in the safety and quality of its products and processes.KEEP LIFE FLOWING VISION Everyone has the right to life. The company is the result of the merger. Kedrion helps individuals. Because of the specific nature of its products. *Universal Declaration of Human Rights. In addition. production. To do this. regenerated. it aims to reinforce its role as strategic partner for health systems in countries aiming to achieve self-sufficiency in the field of plasmaderivatives. stored and carried in the blood. Kedrion produces wealth for investors. security) into the social right to live in the best possible conditions. workers and the local area and it achieves this in a way that is consistent with its vision and the values of responsibility. transparency. liberty and security of person* At times. communities and institutions to limit or remove the obstacles that prevent them from enjoying these rights. in Europe and in the world. processes. liberty. its expertise serves other strategic partnerships with health institutions in other countries. It works to maintain standards of excellence in the sector and strives for continuous improvement to confirm its national leadership and increase its visibility and presence at the international level. trust and respect for people. commercialization and distribution of plasma-derived products. In the international context. scientific.com) is a biopharmaceutical company specialized in the development. The company’s competitive edge relies on the quality of its products. Kedrion produces and markets pharmaceuticals that are derived from human plasma and can improve people’s quality of life. article 3 MISSION In Italy. accidental and social causes stand in the way of the natural right to life. Kedrion is a partner of the National Health Service for self-sufficiency in the field of plasma-derived pharmaceutical products. Kedrion (www. its relentless commitment to research and development. so that it can be transferred from human being to human being and so that anyone and everyone can enjoy fundamental rights.

USA and Mexico. the vaccines are marketed only in Italy. Other activities. among them in particular transfer of technological know-how The other activities con be referred mainly to Technology Transfer. On the market of plasma-derived medicinal products. Plasma collection and commercialization in foreign markets Kedrion is engaged in the collection and marketing of plasma from international plasma collection centres. is working with the health institutions of other countries to export this service. The plasma collected by such centres.KEEP LIFE FLOWING KEDRION QUALITY PROGRAMME KEDRION’S 4 BUSINESS AREAS Production and commercialization of plasma-derived products obtained from the plasma fractionation process Kedrion. subsidiaries in EU. as well as securing a supply of raw materials for Kedrion Group. Kedrion. and more than 40 distributors in other countries. has developed the Kedrion Quality Programme divided into 8 phases: Kedrion’s business model includes: • collection of plasma in Italy and abroad. • production of a broad range of biological products coming from plasma fractionation and purification. • products marketing to final clients through a proprietary network in Italy. Kedrion has the skills and experience required to offer its technological know-how on: • production of one or more products • production of a whole product range • development or upgrading of production lines or fractionation plants 4 5 . is sold to other industry operators as well. • sales of synthetic pharmaceuticals with the aim of extending its range with products complimentary to its plasma-derivatives. Commercialization of flu vaccines and synthetic pharmaceutical products Kedrion’s main lines of business include: • commercialization of influenza vaccines under the trade name Kedrion. in order to monitor products and processes and ensure their safety. supplied by major European manufacturers. relying on its leading position on the Italian market.

KEEP LIFE FLOWING KEDRION PRODUCTS* GENERAL PRODUCTION DIAGRAM EMOCLOT Antihaemophilic factor VIII concentrate AIMAFIX Antihaemophilic factor IX concentrate Coagulation Products UMAN COMPLEX General Production Diagram Plasma inhibitors Prothrombin complex concentrate Albumin Solutions Immunoglobulins HAEMOPHILIA AND OTHER HAEMORRHAGIC DISEASES SOURCE/RECOVERED PLASMA s/d treated plasma S/D TREATMENT THAWING (-1ºC ÷ +3°C) CRYO POOR PLASMA SUPERNATANT PLASMA EMOSINT S/D TREATED PLASMA DDAVP . standard immunoglobulin FRACTION II TETANUS GAMMA FRACTION V ALBUMIN SOLUTION i.m. hepatitis B immunoglobulin VENBIG/KEYVEN i. IMMUNOGLOBULINS i.desmopressin CRYO PASTE AT III KEDRION PROTHROMBIN COMPLEX CONCENTRATE Human antithrombin concentrate AT III UMAN ALBUMIN CRITICAL CARE Human albumin solution Ig VENA FRACTION II+III SUPERNATANT FRACTION IV SUPERNATANT FRACTION II+III i.m. tetanus immunoglobulin i.v. anti-D immunoglobulin IMMUNE SYSTEM DISEASES IMMUNOHBs/UMAN BIG i.m.m.v. IMMUNOGLOBULINS FACTOR IX IMMUNORHO/RHOGAM FACTOR VIII i. hepatitis B immunoglobulin PLASMASAFE** ____________________________________ 6 * Kedrion manufactured and distributed products ** Currently registered only in Italy S/D TREATED PLASMA 7 .v.

being applied at the end of the process it represents a further guarantee with respect to unpredictable cross-contamination 8 9 .KEEP LIFE FLOWING HAEMOPHILIA AND OTHER HAEMORRHAGIC DISEASES PRODUCTION AND SAFETY Two specific virus inactivation steps are applied to our plasma coagulation products HAEMOPHILIA AND OTHER HAEMORRHAGIC DISEASES PRODUCTION DIAGRAM SOURCE/RECOVERED PLASMA THAWING (-1ºC ÷ +3°C) CRYO POOR PLASMA CRYO PASTE PROTHROMBIN COMPLEX CONCENTRATE 1st STEP S/D Treatment .a mixture of TNBP (tri-N-butyl-phosphate) and a vegetable detergent (Tween 80): method effective against lipid enveloped viruses FACTOR IX FACTOR VIII 2nd STEP Dry Heat Treatment 30 min at a temperature of 100º C This method is effective against enveloped and non enveloped viruses.

000 I. A. powder and solvent for solution for infusion + set for reconstitution and administration. 3 years for 200 I. Scaraggi. Treatment of hemophiliacs with antibodies against Factor VIII. A.98 Activated Factors Absent Not detectable vWF:RCo/Ag (ratio) 0.’ A. G. This product may be used in the management of acquired factor IX deficiency./5ml. Haemophilia (2005). Shelf Life: 2 years for 500 I. Fabbrizzi.U.U. A./10ml. ** Test performed according to European Pharmacopea (current edition) ** Test performed according to European Pharmacopea (current edition) Clinical use: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). Echenagucia. Minchilli and N.U./10 ml.70 FII Activity (I. 11: 583-588 11 .U./mg) 113 vWF:Ag (I. only 7 (7.000 I. ____________________________________ ‘Pharmacokinetics.U. Monzini. AIMAFIX is a highly purified double virus inactivated plasma-derived factor IX concentrate. (31 previously untreated patients PUPs and 68 minimally treated patients MTPs).39)./10 ml. Ruiz-Sáez. The concentrate is albumin-free. 1./10 ml. please refer to your local SPC.U. Haemophilia (2006).U.’ A.000 I./mg) 116 Total proteins (mg/ml) 99 Heparin (I. Experience and a recent single blind randomized crossover study have shown that this pd-FIX is well tolerated.M./vial) 0./10 ml. protected from light. 200 I./vial) 1017 Specific activity (I. 12: 128-132 10 Product information abridged from the Italian Summary of Product Characteristics (SPC).U. A. Hong. As not all the information provided applies to your country./vial) 44 ATIII (I. /10 ml) Analytical values – average results on 63 consecutive batches of EMOCLOT** (1. Clinical use: Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor VIII deficiency)Treatment of acquired Factor VIII deficiency. Shelf Life: 3 years. /10 ml) Analysis YEARS 2010/2011 Activity FVIII (I.U. double virus-inactivated and contains large amounts of von Willebrand factor (vWF:RCo/FVIII:C ratio approx 0.U.U. P.1 %). Tagariello. As not all the information provided applies to your country. 1. Product information abridged from the Italian Summary of Product Characteristics (SPC).U. Gringeri. all with severe haemophilia A. ___________________________________ ‘Occurrence of inhibitors in previously untreated or minimally treated patients with haemophilia A after exposure to a plasma-derived solvent-detergent factor VIII concentrate. protected from light. therefore the product is not indicated in von Wille-brand’s disease. In a retrospective survey carried out in 99 haemophilia A patients.U.U./vial) vWF:RCo/FVIII (ratio) 0.9 FX Activity (I. F. has a low thrombogenic activity and no evidence of inhibitor development.KEEP LIFE FLOWING AIMAFIX EMOCLOT Product Characteristics: Product Characteristics: EMOCLOT is a highly purified plasma-derived factor VIII concentrate.U.41 FVII Activity (I. Analytical values – average results on 51 consecutive batches of AIMAFIX** (1. Arguello. had developed inhibitors. F. thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a prothrombin complex concentrate.U.B.U. Bodas. EMOCLOT has been employed for treatment of patients with haemophilia A since 1992 and it has been associated to a very low risk of inhibitor development./vial) Not detectable Total proteins (mg/ml) 0.U. please refer to your local SPC. M.000 I./vial) Not detectable Albumin Absent Presentations: 500 I. Efficacy of EMOCLOT in von Willebrand’s disease has not been proved by a specific clinical trial. M.000 I.U. De Bosch. AIMAFIX has been employed for treatment of patients with haemophilia B since 1993 in more than 20 countries./vial) 56 vWF:RCo (I. powder and solvent for solution for infusion + set for reconstitution and administration./10 ml and 1. Storage: Store at temperature + 2°C / +8°C. Mannucci and the Emoclot15 study members.U./5 ml. Storage: Store at temperature +2°C ÷ +8°C. Presentations: 500 I./vial) 428 Analysis YEARS 2009/2011 Specific activity (I.

Treatment of bleeding and perioperative prophylaxis in congenital deficiency of any of the vitamin K dependent coagulation factors when purified specific coagulation factor product is not available.Protocols for the Treatment of Hemophilia and von Willebrand Disease .desmopressin) is a synthetic analogue of vasopressin. or in case of overdose of vitamin K antagonists. 8: 607-621 WFH publications: .’ P.U.U./vial) and the content of ATIII (± 1. Bodas. F.U. EMOSINT increases FVIII and vWFactor plasma concentrations when administered to patients with vWD or mild and moderate haemophilia A. Storage: Store at temperature + 2°C ÷ +8°C. G.3 I.U. Diagnosis and Clinical Management of Von Willebrand Disease 13 . De Bosch. Federici. 11: 583-588 12 Product information abridged from the Italian Summary of Product Characteristics (SPC). A./vial) and heparin (± 60 I. prothrombin complex concentrate containing: human plasma coagulation factor IX (Christmas factor).Mild and moderate haemophilia A . Rodeghiero. 20 mcg/1 ml. Cattaneo.type I von Willebrand disease. protected from light.’ A.B. G. F. A. when rapid correction of the deficiency is required ________________________________ ‘Desmopressin (DDAVP): The first thirty years. Castaman. such as deficiency caused by treatment with vitamin K antagonists. DDAVP is the treatment of choice for type I Von Willebrand disease and mild and moderate haemophilia A. Minchilli and N. Mannucci for the Italian Association of Haemophilia Centres (AICE)./vial Clinical use: . Storage: Store at temperature + 2°C ÷ +8°C. .M.U. 14 (1). Echenagucia. Presentation: 500 I. protected from light. / 20ml) Human Plasma factor IX * Human Plasma factor II Human Plasma factor X 500 I. please refer to your local SPC. Quantitative composition UMAN COMPLEX (500 I. human plasma coagulation factor X (StuartPrower factor). ‘Guidelines for the diagnosis and management of von Willebrand disease in Italy.2 I.KEEP LIFE FLOWING EMOSINT UMAN COMPLEX Product Characteristics: Product Characteristics: UMAN COMPLEX is a highly purified. . Shelf life: 2 years when stored in intact package./vial 400 I. human plasma coagulation factor II (Prothrombin).U. Hong. A. EMOSINT (DDVAP .U. double virus-inactivated. Castaman and P. M.’ A. * Factor IX titrated in accordance to international standard Presentations: 10 ampoules.5 ml./vial 500 I. ___________________________________ ‘Pharmacokinetics. The lack of factor VII (± 1. Following an initial clinical trial performed in 1977 DDAVP has become widely used for the treatment of these diseases. please refer to your local SPC. Haemophilia (2005). leaving the efficacy and the anti-inhibitor activity unchanged. Mannuci. A. M. Fabbrizzi. Haemophilia (2008)./vial) could suggest a less thrombogenicity of the product. Ruiz-Sáez. thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a prothrombin complex concentrate. A. Product information abridged from the Italian Summary of Product Characteristics (SPC). F. Clinical use: -Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors. As not all the information provided applies to your country.B.U. Coppola. 10 ampoules. Haemophilia (2002). 4 mcg/0./20 ml. G. Arguello. As not all the information provided applies to your country.M.The Basic Science. Federici. Di Minno.Preparation for surgery of haemophiliacs and patients with von Willebrand disease. Originally DDAVP was designed for treating diabetes insipidus. Shelf Life: 3 years.B. powder and solvent for solution for infusion + infusion set.

m. and i. Precipitation and removal of Fraction I 2. IMMUNOGLOBULINS Low pH treatment i.v. respectively. Precipitation and filtration of Fraction II+III 3. Precipitation and removal of Fraction III 5th STEP (Ig VENA) i.v.KEEP LIFE FLOWING IMMUNE SYSTEM DISEASES PRODUCTION AND SAFETY IMMUNE SYSTEM DISEASES The precipitation and removal of fraction I and III as well as the precipitation and filtration of fraction II+III in the production process. Production Diagram SOURCE/RECOVERED PLASMA CRYO POOR PLASMA SUPERNATANT PLASMA 4th STEP S/D Treatement A mixture of TNBP (tri-N-butyl-phosphate) and Sodium Cholate 1st. 3rd STEP FRACTION II+III FRACTION II 5th STEP (VENBIG) Pepsin treatment at low pH Three Validated Virus Removal steps 1.m. have been validated for all our immunoglobulins. immunoglobulins. 2nd. Ig VENA and VENBIG also have a fifth specific inactivation step: low pH treatment and pepsin treatment at low pH. A specific inactivation step (S/D treatment) has been added for both i. IMMUNOGLOBULINS 14 15 .

8 18. P. ________________________________ ‘Protocol liver biopsies in long-term management of patients transplanted for hepatitis B-related liver disease.1%) 4 (34%) Mild ADR After Infusion 5 (2. Immunomodulation in adults. Buerra. and children and adolescents (0-18 years) in: • Primary immune thrombocytopenia (ITP).0% 0.U.1) Ig3 (g/l) (0. Naccarato. Targhetta.average results on 150 batches EFFICACY European Average on 151 Internal Controls Pharmacopeia ___________________________________ CONSISTENCY ‘Terapia con immunoglobuline per via endovenosa: studio prospettico di sorveglianza degli effetti collaterali.0% Polymers: ≤ 3.KEEP LIFE FLOWING Ig VENA Product Characteristics: Presentations: Ig VENA 50 g/L 20 ml solution for infusion.83% A Post Marketing Surveillance prospectic study on side effects of Ig VENA on 192 patients assessed the extremely low incidence of Adverse Drug Reaction related to Ig VENA infusions (*). 200 ml solution for infusion + infusion set.32 1. Rivista di Immunologia e Allergologia Pediatrica (2007). Shelf life: 2 years when stored in intact package.G. and children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia. Ugazio. S. S.’ A.7%) 12/1670 treat.26 20.31 0. Fiorentino. A. Grossi.05 2.7%) Symptomatology 2 Fever 2 Headache 7 Fever 1 Headache Clinical use: Replacement therapy in adults. Pontisso. F.U. administration.10-0.In the newborn of a hepatitis B virus carrier-mother . Cecchetto. D. Scarpellini. protected from light.4-22. As not all the information provided applies to your country.05 AntiHBsAg-Ab (UI/ml) ≥ 0.500 I. • Guillain Barré syndrome. Guazzini.36 087610 32.43 IgM content: not required IgM: (μg/ml) ≤ 10 0.90-1. 5: 37-45. • Congenital AIDS with recurrent bacterial infections. Shelf life: 3 years.3 21. 2.6 1. until vaccination has become effective . (0.48 Aluminium: not required Aluminium ppb ≤ 200 22 Average 33.10 0. Number and type of ADRs in 1670 treatments with Ig VENA on 192 patients Type of ADR ADR During Infusion 4 (2. powder and solvent for solution for infusion + infusion set. Tognoni. 100 ml. Storage: Store at temperature between + 2°C ÷ +8°C.5 1.6%) 8 (66%) Mild Total 9/192 pc.3-37. please refer to your local SPC. Ig VENA is Kedrion’s human normal immunoglobulin 5% for i.36 Ig4 (g/l) (0. P. • Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation.2) Ig2 (g/l) (12. P. Product Characteristics: VENBIG is a human hepatitis B immunoglobulin for i.50) 087601 29. Number of Patients (%) Clinical use: • Prevention of hepatitis B virus recurrence after liver transplantation for hepatitis B virus liver failure in combination with antiviral therapy. F. • Immunoprophylaxis of hepatitis B: . R. A.37 0.6 087651 34. S. in whom prophylactic antibiotics have failed.0 1.45% AntiHBsAg-Ab (UI/ml) ≥ 0.In case of accidental exposure in non-immunised subjects (including persons whose vac cination is incomplete or status unknown) . (4.8 19. It is a fully functional native immunoglobulin with five different validated steps of viral inactivation/removal and a high level of efficacy and tolerability. Presentations: VENBIG 500 I.50) Mono + dime: ≥ 90% Mono + dime: ≥ 90% 99. with a very high safety profile guaranteed by five validated inactivation/removal steps. ‘Intravenous Immunoglobulin Therapy in the treatment of the acute phase of chronic idiopathic thrombocytopenic purpura in adults. ANALYTICAL VALUES .05% 087636 35.3 20. Balestri. Number of ADRs (%) Product information abridged from the Italian Summary of Product Characteristics (SPC). • Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT). Inturri. M.In haemodialysed patients.6 1.5% Fragments: ≤ 5% Fragments : ≤ 5% 0. As not all the information provided applies to your country. Cillo. in patients at high risk of bleeding or prior to surgery to correct the platelet count. Fagiuoli.In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B./10ml. World Journal of Gastroenterology (2006). C. F. • Kawasaki disease 16 Product information abridged from the Italian Summary of Product Characteristics (SPC). 9 (4): 567-571 IgG Subclasses Batches Batch Ig1 (g/l) (24.5 1. B.8 20.1 087625 31. Villamil. 12: 1706-1712 17 .3 087647 35.’ S.27 0.v. Soresina. Haema (2006).15 0.7 1. Guarnieri.42 Ig anti D: not required Ig anti D: no reaction negative PKA (UI/ml): ≤ 35 PKA (UI/ml): ≤ 35 <2 ACA %: ≤ 50 ACA %: ≤ 50 26 VENBIG / KEYVENB INTEGRITY European Pharmacopeia Internal Controls Average Fc Integrity: ≥ 60% Fc Integrity: ≥ 60% 95. Minchilli./50ml.7 21.v.48 0.48 IgA content: not required IgA: (μg/ml) ≤ 50 4. Gianni.’ A.20 0. use. Storage: Do not store above 25°C.38 Polymers: ≤ 3. 50 g/L 50 ml. U. please refer to your local SPC.

solution for injection for i.U.U.U.Planned antenatal prophylaxis .500 I. intrauterine fetal death./2 ml solution for injection for intramuscular use. 2.m. A.U. F. use. 300 mcg (1. P. P. 1000 I. please refer to your local SPC. Product Characteristics: IMMUNORHO is Kedrion’s human anti-D immunoglobulin in powder.m. Cecchetto. Pontisso. Naccarato. Inturri. obstetric manipulative procedures e. Dweak. in pre-filled syringe for i.U. for i. amniocentesis. As not all the information provided applies to your country. please refer to your local SPC. Presentations: TETANUS GAMMA 250 I. Presentations: IMMUNOHBs 180 I. TETANUS GAMMA 19 . U.m. Product information abridged from the Italian Summary of Product Characteristics (SPC). Gianni. Cillo. until vaccination has become effective ./2 ml./1ml.) and 300 mcg (1. Therapy of clinically manifest tetanus. protected from light. World Journal of Gastroenterology (2006). 12: 1706-1712 For Rhogam. Clinical use: Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure.g.KEEP LIFE FLOWING IMMUNOHBs / UMAN BIG IMMUNORHO / RHOGAM Product Characteristics: IMMUNOHBS is an hepatitis B immunoglobulin for i. Storage: Store at temperature + 2°C ÷ +8°C. As not all the information provided applies to your country.U. Shelf life: 3 years. Active tetanus vaccination should always be administered in conjunction with tetanus immunoglobulin unless there are contraindications or confirmationof adequate vaccination. S. Buerra. Clinical use: Prevention of Rh(D) immunisation in Rh(D) negative women.Delivery of a Rh(D) positive (D. Shelf life: 3 years. Presentation: IMMUNORHO 200 mcg (1. Post-exposure prophylaxis. Dpartial) baby Treatment of Rh(D) negative persons after incompatible transfusions of Rh(D) positive blood or other products containing red blood cells e. 250 I. Fagiuoli. its safety profile is guaranteed by four validated inactivation/removal steps. blunt abdominal trauma or fetal therapeutic intervention. administration. please refer to your local SPC for guidance. 18 Product information abridged from the Italian Summary of Product Characteristics (SPC).In subjects who did not show an immune re-sponse (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being in-fected with hepatitis B. __________________________________ Shelf life: 3 years. Targhetta.500 I.g.In the newborn of a hepatitis B virus carrier-mother .In case of accidental exposure in non-immuni sed subjects (including persons whose vaccination is incomplete or status unknown) .U. platelet concentrate. R. ‘Protocol liver biopsies in long-term management of patients transplanted for hepatitis B-related liver disease. powder and solvent for solution for injection for i.Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated. S. Immunoprophylaxis of hepatitis B .m. • Postnatal prophylaxis . cordocentesis./3 ml with pre-filled ready-to-use syringe. use. for intramuscular use. Clinical use: 1.U. Product Characteristics: TETANUS GAMMA is Kedrion’s human tetanus immunoglobulin ready to use./ 3 ml solution for injection.In haemodialysed patients.U. Its safety is guaranteed by four validated virus inactivation/removal steps. invasive interventions. 500 I.Antenatal prophylaxis following complications of pregnancy including: Abortion/threatened abortion.m. its safety profile is guaranteed by four validated inactivation/removal steps. chorionic biopsy. Storage: Should be stored in a refrigerator +2°C ÷ +8°C. and in patients with severe deficiencyin anti-body production./1 ml. Villamil. P. Storage: Store below 25°C. use. ectopic pregnancy or hydatidiform mole. use.’ S.). transplacental haemorrhage resulting from ante-partum haemorrhage. 540 I. in patients whose immunisation status is not known with cer-tainty.). external version. • Antenatal prophylaxis .000 I.

Storage: Store in refrigerator at +2°C ÷ +8°C. or in a refrigerator at 2°C ÷ 8°C.U. Haematologica Reports (2005).0 I. other acute consumption coagulopathies.U. D’Angelo. Presentations: AT III KEDRION 500 I. AT Eterolog Proteins Absent Clinical use: In patients with congenital antithrombin deficiency: . protected from light. please refer to your local SPC. 1 (10) AT III PRODUCTION AND SAFETY Two different steps of viral inactivation (pasteurization) and virus removal (nanofiltration) are applied to ATIII Kedrion before sterile filtration and subsequent filling and lyophilization. The reconstituted product may be stored for 8 hours at a temperature below 30°C. ___________________________________ 20 Product information abridged from the Italian Summary of Product Characteristics (SPC). politrauma. ‘The microangiopathy of pregnancy. As not all the information provided applies to your country.Prevention of progression of deep vein thrombosis and thromboembolism in association with heparin.0-7./10ml. powder and solvent for solution for infusion.KEEP LIFE FLOWING AT III KEDRION Product Characteristics: Highly purified double virus-inactivated antithrombin concentrate./20ml.U. . Shelf life: 3 years. of Heparin/I. L.1. CRITICAL CARE Activity 50±5 I.’ A. Production Diagram SOURCE/RECOVERED PLASMA 1st STEP AT III crude preparation is pasteurized at 60° C for 10h CRYO POOR PLASMA AT III 2nd STEP Nanofiltration with two different filters at 35nm and 15 nm 21 ./mg proteins Proteic Composition ≥ 90% AT Heparin Content 0.U. Valsecchi on behalf of the ATIII-EPAS Study group.Prophylaxis of deep vein thrombosis and thromboembolism in high risk patients (especially during surgery or during the peri-partum period).000 I. In patients with acquired antithrombin deficiency: disseminated intravascular coagulation (DIC) associated with: severe sepsis.5 Osmolality ≥ 240 mosmol/Kg Solubility ≤ 10 min Specific Activity ± 5. pregnancy. burns./ml pH 6. in association with heparin if indicated. when indicated.1 I.U.U.

polymers and aggregates: Analysis Results on 120 consecutive batches Eu. Merke./ml < 136. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis: similar efficacy at lower cost.25%) Total proteins 18 mcg/l < 200 mcg/l 3. Cillo. _________________________________ ‘Switch therapy with ciproflaxin vs. F. and use of a colloid is appropriate. S.U. please refer to your local SPC. R. 250gr/l (in 50 ml vial). The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient. Piccolo. Franchin. Fasolato.5 mmoli/l 129 mmoli/l 190-210 g/l (±10% quantity stated on the label) 196 g/l Clinical use: Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated. Four steps are part of the Cohn fractionation method while a specific step of pasteurization has been added. As not all the information provided applies to your country. Gatta. 1st STEP Precipitation and Removal of Fraction I 2nd STEP Precipitation and filtration of Fraction II+III FRACTION II+III SUPERNATANT FRACTION IV SUPERNATANT FRACTION V ALBUMIN SOLUTION Production Diagram SOURCE/RECOVERED PLASMA CRYO POOR PLASMA SUPERNATANT PLASMA 3rd STEP Precipitation and filtration of Fraction IV 4th STEP Precipitation of crude Fraction V 5th STEP Heat treatment at 60°C for 10h (pasteurization) Product information abridged from the Italian Summary of Product Characteristics (SPC). Brollo. protected from light. ph requrements Polymers and aggregates 1. Craighero. M. U. 5gr/100 ml (in 250 ml vial).5 I. C./ml < 35 I. Storage: Do not store the product above 30°C. Presentations: UMAN ALBUMIN 200gr/l (in 50 and 100 ml vial). C. S. UMAN ALBUMIN 22 23 .KEEP LIFE FLOWING UMAN ALBUMIN Product Characteristics: UMAN ALBUMIN is a human albumin solution with a very low content of aluminum. Alimentary Pharmacology & Therapeutics (2006) PRODUCTION AND SAFETY Five different steps have been validated for their ability to remove/inactivate viruses. Shelf life: 3 years when stored in intact package. based on official recommendations. solution for infusion.D. E.U.’ P. L. Angeli. Miola.4% < 5% Aluminium pKA Sodium (20% . Antona. Guarda. A.