5980367 (03/2013)

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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KEEP LIFE FLOWING

VISION
Everyone has the right to life, liberty and security of person*
At times, natural, accidental and social causes stand in the way of the natural right to life,
liberty and security of person.
Because of the specific nature of its products, Kedrion helps individuals, communities
and institutions to limit or remove the obstacles that prevent them from enjoying these
rights.
Kedrion contributes to transforming natural right (life, liberty, security) into the social
right to live in the best possible conditions. To do this, it gathers, processes, activates
and makes it possible to use the vital energy that is generated, regenerated, stored and
carried in the blood, so that it can be transferred from human being to human being and
so that anyone and everyone can enjoy fundamental rights.

Kedrion (www.kedrion.com) is a biopharmaceutical company

specialized in the development, production, commercialization
and distribution of plasma-derived products.
The company is the result of the merger, which took place
in 2001, of different companies operating in the sector and it
acquired a heritage of expertise that secures it a prominent
role in Italy, in Europe and in the world.
Kedrion stands out for its great attention to the international
horizon and for the promotion of the local community.

*Universal Declaration of Human Rights, article 3

MISSION

In Italy, Kedrion is a partner of the National Health Service for

self-sufficiency in the field of plasma-derived pharmaceutical
products. In addition, its expertise serves other strategic
partnerships with health institutions in other countries.

Kedrion produces and markets pharmaceuticals that are derived from human plasma
and can improve peoples quality of life.

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.

The companys competitive edge relies on the quality of

its products, its relentless commitment to research and
development.

It works to consolidate its role as the spokesperson acknowledged by the medical,

scientific, health and institutional communities.

In the international context, it aims to reinforce its role as strategic partner for health systems
in countries aiming to achieve self-sufficiency in the field of plasmaderivatives.
Kedrion produces wealth for investors, workers and the local area and it achieves this in
a way that is consistent with its vision and the values of responsibility, transparency, trust
and respect for people.

VALUES
Kedrion declares that:
social responsibility is the guiding principle of the companys 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, honest and informed

Its attention to and respect for people takes real form in the safety and quality of its
products and processes.

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KEDRION QUALITY PROGRAMME

KEDRIONS 4 BUSINESS AREAS

Production and commercialization of plasma-derived products
obtained from the plasma fractionation process

Kedrion, in order to monitor products and processes and ensure their safety, has
developed the Kedrion Quality Programme divided into 8 phases:

Kedrions 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, subsidiaries
in EU, USA and Mexico, and more than 40 distributors in other countries. Kedrion,
relying on its leading position on the Italian market, is working with the health
institutions of other countries to export this service.
Commercialization of flu vaccines and synthetic pharmaceutical
products
Kedrions main lines of business include:
commercialization of influenza vaccines under the trade name Kedrion,
supplied by major European manufacturers; the vaccines are marketed only in
Italy.
sales of synthetic pharmaceuticals with the aim of extending its range with
products complimentary to its plasma-derivatives.
Plasma collection and commercialization in foreign markets
Kedrion is engaged in the collection and marketing of plasma from international
plasma collection centres. The plasma collected by such centres, as well as
securing a supply of raw materials for Kedrion Group, is sold to other industry
operators as well.
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, 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

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 (-1C +3C)

CRYO POOR
PLASMA
SUPERNATANT
PLASMA

EMOSINT

S/D TREATED
PLASMA

DDAVP - 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.v. standard immunoglobulin

FRACTION II

TETANUS GAMMA

FRACTION V

ALBUMIN SOLUTION

i.m. tetanus immunoglobulin

i.v. IMMUNOGLOBULINS
i.m. IMMUNOGLOBULINS

FACTOR
IX

IMMUNORHO/RHOGAM

FACTOR
VIII

i.m. anti-D immunoglobulin

IMMUNE SYSTEM DISEASES

IMMUNOHBs/UMAN BIG
i.m. hepatitis B immunoglobulin

VENBIG/KEYVEN
i.v. hepatitis B immunoglobulin

PLASMASAFE**

____________________________________
6

* Kedrion manufactured and distributed products

** Currently registered only in Italy

S/D TREATED PLASMA

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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 (-1C +3C)
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 100 C
This method is effective against enveloped and
non enveloped viruses; being applied at the end of
the process it represents a further guarantee with
respect to unpredictable cross-contamination

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AIMAFIX

EMOCLOT
Product Characteristics:

Product Characteristics:

EMOCLOT is a highly purified plasma-derived factor VIII concentrate. The concentrate

is albumin-free, double virus-inactivated and contains large amounts of von Willebrand
factor (vWF:RCo/FVIII:C ratio approx 0.39). 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. In a retrospective survey carried out in 99 haemophilia A patients,
(31 previously untreated patients PUPs and 68 minimally treated patients MTPs), only 7
(7,1 %), all with severe haemophilia A, had developed inhibitors.

AIMAFIX is a highly purified double virus inactivated plasma-derived factor IX concentrate. AIMAFIX has been employed for treatment of patients with haemophilia B since 1993
in more than 20 countries. Experience and a recent single blind randomized crossover
study have shown that this pd-FIX is well tolerated, has a low thrombogenic activity and
no evidence of inhibitor development.

Analytical values average results on 51 consecutive

batches of AIMAFIX** (1.000 I.U. /10 ml)

Analytical values average results on 63 consecutive

batches of EMOCLOT** (1.000 I.U. /10 ml)
Analysis

YEARS 2010/2011

Activity FVIII
(I.U./vial)

1017

Specific activity
(I.U./mg)

113

vWF:Ag
(I.U./vial)

56

vWF:RCo
(I.U./vial)

428

Analysis

YEARS 2009/2011

Specific activity
(I.U./mg)

116

Total proteins
(mg/ml)

99

Heparin
(I.U./vial)

44

ATIII
(I.U./vial)

0,98

Activated Factors

Absent
Not detectable

vWF:RCo/Ag
(ratio)

0,70

FII Activity
(I.U./vial)

vWF:RCo/FVIII
(ratio)

0,41

FVII Activity
(I.U./vial)

Not detectable

Total proteins
(mg/ml)

0,9

FX Activity
(I.U./vial)

Not detectable

Albumin

Absent

Presentations: 500 I.U./10 ml, 1.000 I.U./10 ml, powder and solvent for solution for infusion + set for reconstitution and administration.
Storage: Store at temperature + 2C / +8C, protected from light.
Shelf Life: 3 years.

___________________________________

Occurrence of inhibitors in previously untreated or minimally treated patients with haemophilia A after exposure to a plasma-derived solvent-detergent factor VIII concentrate.
A. Gringeri, M. Monzini, G. Tagariello, A. Scaraggi, P.M. Mannucci and the Emoclot15 study members, Haemophilia
(2006), 12: 128-132

10

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

Clinical use:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor
VIII deficiency)Treatment of acquired Factor VIII deficiency. Treatment of hemophiliacs
with antibodies against Factor VIII. Efficacy of EMOCLOT in von Willebrands disease has
not been proved by a specific clinical trial, therefore the product is not indicated in von
Wille-brands disease.

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

** 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).
This product may be used in the management of acquired factor IX deficiency.
Presentations: 500 I.U./10 ml, 1.000 I.U./10ml, 200 I.U./5 ml, powder and solvent for
solution for infusion + set for reconstitution and administration.
Storage: Store at temperature +2C +8C, protected from light.
Shelf Life: 2 years for 500 I.U./10 ml and 1.000 I.U./10 ml; 3 years for 200 I.U./5ml.

____________________________________

Pharmacokinetics, thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a
prothrombin complex concentrate.
A. Ruiz-Sez, A. Hong, A. Arguello, M. Echenagucia, A. Bodas, F. Fabbrizzi, F. Minchilli and N.B. De Bosch, Haemophilia
(2005), 11: 583-588

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KEEP LIFE FLOWING

EMOSINT

UMAN COMPLEX
Product Characteristics:

Product Characteristics:

UMAN COMPLEX is a highly purified, double virus-inactivated, prothrombin complex

concentrate containing: human plasma coagulation factor IX (Christmas factor), human
plasma coagulation factor II (Prothrombin), human plasma coagulation factor X (StuartPrower factor).

EMOSINT (DDVAP - desmopressin) is a synthetic analogue of vasopressin.

Originally DDAVP was designed for treating diabetes insipidus.
EMOSINT increases FVIII and vWFactor plasma concentrations when administered to
patients with vWD or mild and moderate haemophilia A.
Following an initial clinical trial performed in 1977 DDAVP has become widely used for the
treatment of these diseases.
DDAVP is the treatment of choice for type I Von Willebrand disease and mild and moderate haemophilia A.

Quantitative composition UMAN COMPLEX

(500 I.U. / 20ml)
Human Plasma factor IX *
Human Plasma factor II
Human Plasma factor X

500 I.U./vial
500 I.U./vial
400 I.U./vial

Clinical use:
- Mild and moderate haemophilia A - type I von Willebrand disease;
- Preparation for surgery of haemophiliacs and patients with von Willebrand disease;

* Factor IX titrated in accordance to international standard

Presentations: 10 ampoules, 4 mcg/0,5 ml; 10 ampoules, 20 mcg/1 ml.

Storage: Store at temperature + 2C +8C, protected from light.
Shelf life: 2 years when stored in intact package.

The lack of factor VII ( 1,3 I.U./vial) and the content of ATIII ( 1,2 I.U./vial) and heparin
( 60 I.U./vial) could suggest a less thrombogenicity of the product, leaving the efficacy
and the anti-inhibitor activity unchanged.

Presentation: 500 I.U./20 ml, powder and solvent for solution for infusion + infusion set.
Storage: Store at temperature + 2C +8C, protected from light.
Shelf Life: 3 years.

___________________________________

Pharmacokinetics, thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a
prothrombin complex concentrate.
A. Ruiz-Sez, A. Hong, A. Arguello, M. Echenagucia, A. Bodas, F. Fabbrizzi, F. Minchilli and N.B. De Bosch, Haemophilia
(2005), 11: 583-588

12

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

- 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.

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

Clinical use:
-Treatment of bleeding and perioperative prophylaxis of bleeding 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

________________________________

Desmopressin (DDAVP): The first thirty years.

P.M. Mannuci, A.B. Federici, G. Castaman, F. Rodeghiero, A. Coppola, G. Di Minno, M. Cattaneo, Haemophilia (2008),
14 (1);
Guidelines for the diagnosis and management of von Willebrand disease in Italy.
A.B. Federici, G. Castaman and P.M. Mannucci for the Italian Association of Haemophilia Centres (AICE), Haemophilia
(2002), 8: 607-621
WFH publications:
- Protocols for the Treatment of Hemophilia and von Willebrand Disease
- The Basic Science, Diagnosis and Clinical Management of Von Willebrand Disease

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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, have been validated for all our immunoglobulins. A specific inactivation step (S/D treatment) has been added for both i.m. and i.v. immunoglobulins.
Ig VENA and VENBIG also have a fifth specific inactivation step: low pH treatment and pepsin treatment at low pH, respectively.

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, 2nd, 3rd STEP

FRACTION II+III
FRACTION II

5th STEP (VENBIG)

Pepsin treatment at low pH

Three Validated Virus Removal steps

1. Precipitation and removal of Fraction I
2. Precipitation and filtration of Fraction II+III
3. Precipitation and removal of Fraction III

5th STEP (Ig VENA)

i.v. IMMUNOGLOBULINS

Low pH treatment

i.m. IMMUNOGLOBULINS

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Ig VENA
Product Characteristics:

Presentations:
Ig VENA 50 g/L 20 ml solution for infusion; 50 g/L 50 ml; 100 ml; 200 ml solution for infusion + infusion set.
Storage: Store at temperature between + 2C +8C, protected from light.
Shelf life: 2 years when stored in intact package.

Ig VENA is Kedrions human normal immunoglobulin 5% for i.v. use. It is a fully functional
native immunoglobulin with five different validated steps of viral inactivation/removal and
a high level of efficacy and tolerability.

ANALYTICAL VALUES - 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.
A. Soresina, A.G. Ugazio, Rivista di Immunologia e Allergologia Pediatrica (2007), 5: 37-45;
Intravenous Immunoglobulin Therapy in the treatment of the acute phase of chronic idiopathic thrombocytopenic purpura
in adults.
A. Grossi, F. Balestri, D. Tognoni, F. Minchilli, B. Fiorentino, C. Guarnieri, M. Scarpellini, S. Guazzini, Haema (2006), 9
(4): 567-571

IgG Subclasses

Batches

Batch

Ig1 (g/l) (24,3-37,2)

Ig2 (g/l) (12,4-22,1)

Ig3 (g/l) (0,90-1,50)

087601

29,8

20,6

1,20

0,36

087610

32,7

21,5

1,15

0,36

Ig4 (g/l) (0,10-0,50)

Mono + dime: 90%

Mono + dime: 90%

99,5%

Fragments: 5%

Fragments : 5%

0,45%

AntiHBsAg-Ab (UI/ml)
0,05

AntiHBsAg-Ab (UI/ml) 0,05

2,1

087625

31,3

21,5

1,10

0,38

Polymers: 3.0%

Polymers: 3.0%

0,05%

087636

35,8

18,0

1,48

0,48

IgA content: not required

IgA: (g/ml) 50

4,3

087647

35,8

19,7

1,37

0,43

IgM content: not required

IgM: (g/ml) 10

0,6

087651

34,3

20,6

1,31

0,48

Aluminium: not required

Aluminium ppb 200

22

Average

33,26

20,32

1,27

0,42

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%

95,83%

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 (*).

Product Characteristics:
VENBIG is a human hepatitis B immunoglobulin for i.v. administration, with a very high
safety profile guaranteed by five validated inactivation/removal steps.

Number and type of ADRs in 1670 treatments with Ig VENA on 192 patients
Type of ADR

ADR During Infusion

4 (2.1%)

4 (34%)

Mild

ADR After Infusion

5 (2.6%)

8 (66%)

Mild

Total

9/192 pc. (4,7%)

12/1670 treat. (0,7%)

Symptomatology

2 Fever
2 Headache
7 Fever
1 Headache

Clinical use:
Replacement therapy in adults, 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, in whom prophylactic antibiotics have failed.
Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple
myeloma patients who have failed to respond to pneumococcal immunisation.
Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT).
Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, and children and adolescents (0-18 years) in:
Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to
surgery to correct the platelet count.
Guillain Barr syndrome.
Kawasaki disease

16

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

Number of ADRs (%)

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

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.
Immunoprophylaxis of hepatitis B:
- In case of accidental exposure in non-immunised subjects (including persons whose vac
cination is incomplete or status unknown)
- In haemodialysed patients, until vaccination has become effective
- In the newborn of a hepatitis B virus carrier-mother
- 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.
Presentations: VENBIG 500 I.U./10ml; 2.500 I.U./50ml; powder and solvent for solution
for infusion + infusion set.
Storage: Do not store above 25C.
Shelf life: 3 years.

________________________________

Protocol liver biopsies in long-term management of patients transplanted for hepatitis B-related liver disease.
S. Targhetta, F. Villamil, P. Inturri, P. Pontisso, S. Fagiuoli, U. Cillo, A. Cecchetto, S. Gianni, R. Naccarato, P. Buerra, World
Journal of Gastroenterology (2006), 12: 1706-1712

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KEEP LIFE FLOWING

IMMUNOHBs / UMAN BIG

IMMUNORHO / RHOGAM

Product Characteristics: IMMUNOHBS is an hepatitis B immunoglobulin for i.m.

administration. Its safety is guaranteed by four validated virus inactivation/removal steps.

Product Characteristics:
IMMUNORHO is Kedrions human anti-D immunoglobulin in powder, for i.m. use, its safety profile is guaranteed by four validated inactivation/removal steps.

Clinical use:
Prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure.
Immunoprophylaxis of hepatitis B
- In case of accidental exposure in non-immuni sed subjects (including persons whose
vaccination is incomplete or status unknown)
- In haemodialysed patients, until vaccination has become effective
- In the newborn of a hepatitis B virus carrier-mother
- 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.

Clinical use:
Prevention of Rh(D) immunisation in Rh(D) negative women.
Antenatal prophylaxis
- Planned antenatal prophylaxis
- Antenatal prophylaxis following complications of pregnancy including: Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine fetal death, transplacental haemorrhage resulting from ante-partum haemorrhage, amniocentesis, chorionic
biopsy, obstetric manipulative procedures e.g. external version, invasive interventions,
cordocentesis, blunt abdominal trauma or fetal therapeutic intervention.
Postnatal prophylaxis
- Delivery of a Rh(D) positive (D, Dweak, Dpartial) baby
Treatment of Rh(D) negative persons after incompatible transfusions of Rh(D) positive
blood or other products containing red blood cells e.g. platelet concentrate.

Presentations: IMMUNOHBs 180 I.U./1ml; 540 I.U./ 3 ml solution for injection, for
intramuscular use; 1000 I.U./3 ml with pre-filled ready-to-use syringe.
Storage: Store at temperature + 2C +8C.
Shelf life: 3 years.

Presentation: IMMUNORHO 200 mcg (1.000 I.U.) and 300 mcg (1.500 I.U.), powder and
solvent for solution for injection for i.m. use; 300 mcg (1.500 I.U.), solution for injection
for i.m. use.
Storage: Store below 25C.

__________________________________

Shelf life: 3 years.

Protocol liver biopsies in long-term management of patients transplanted for hepatitis B-related liver disease.
S. Targhetta, F. Villamil, P. Inturri, P. Pontisso, S. Fagiuoli, U. Cillo, A. Cecchetto, S. Gianni, R. Naccarato, P. Buerra,
World Journal of Gastroenterology (2006), 12: 1706-1712

For Rhogam, please refer to your local SPC for guidance.

Clinical use:
1. Post-exposure prophylaxis.Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with
cer-tainty, and in patients with severe deficiencyin anti-body production.
2. Therapy of clinically manifest tetanus. Active tetanus vaccination should always be administered in conjunction with tetanus immunoglobulin unless there are contraindications
or confirmationof adequate vaccination.
Presentations:
TETANUS GAMMA 250 I.U./1 ml; 250 I.U./2 ml; 500 I.U./2 ml solution for injection for
intramuscular use.
Storage: Should be stored in a refrigerator +2C +8C, protected from light.
Shelf life: 3 years.

18

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

Product Characteristics: TETANUS GAMMA is Kedrions human tetanus immunoglobulin ready to use, in pre-filled syringe for i.m. use, its safety profile is guaranteed by four
validated inactivation/removal steps.

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

TETANUS GAMMA

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AT III KEDRION
Product Characteristics:
Highly purified double virus-inactivated antithrombin concentrate.

CRITICAL CARE

Activity

505 I.U./ml

pH

6,0-7,5

Osmolality

240 mosmol/Kg

Solubility

10 min

Specific Activity

5,0 I.U./mg proteins

Proteic Composition

90% AT

Heparin Content

0,1 I.U. of Heparin/I.U. AT

Eterolog Proteins

Absent

Clinical use:
In patients with congenital antithrombin deficiency:
- Prophylaxis of deep vein thrombosis and thromboembolism in high risk patients (especially during surgery or during the peri-partum period), in association with heparin if indicated;
- Prevention of progression of deep vein thrombosis and thromboembolism in association
with heparin, when indicated.
In patients with acquired antithrombin deficiency:
disseminated intravascular coagulation (DIC) associated with: severe sepsis, politrauma,
burns, pregnancy; other acute consumption coagulopathies.
Presentations:
AT III KEDRION 500 I.U./10ml;1.000 I.U./20ml; powder and solvent for solution for infusion.
Storage: Store in refrigerator at +2C +8C, protected from light.

Shelf life: 3 years.

The reconstituted product may be stored for 8 hours at a temperature below 30C, or in
a refrigerator at 2C 8C.

___________________________________

20

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

The microangiopathy of pregnancy.

A. DAngelo, L. Valsecchi on behalf of the ATIII-EPAS Study group. Haematologica Reports (2005), 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.
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

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UMAN ALBUMIN
Product Characteristics:
UMAN ALBUMIN is a human albumin solution with a very low content of aluminum, polymers and aggregates:
Analysis

Results on 120 consecutive batches

Eu. ph requrements

Polymers and aggregates

1,4%

< 5%

Aluminium
pKA

Sodium (20% - 25%)

Total proteins

18 mcg/l

< 200 mcg/l

3,5 I.U./ml

< 35 I.U./ml

< 136,5 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, and use of a colloid is appropriate. The choice of albumin rather than
artificial colloid will depend on the clinical situation of the individual patient, based on
official recommendations.
Presentations:
UMAN ALBUMIN 200gr/l (in 50 and 100 ml vial); 250gr/l (in 50 ml vial); 5gr/100 ml (in 250
ml vial); solution for infusion.
Storage: Do not store the product above 30C, protected from light.
Shelf life: 3 years when stored in intact package.

_________________________________

Switch therapy with ciproflaxin vs. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients
with cirrhosis: similar efficacy at lower cost.
P. Angeli, S. Guarda, S. Fasolato, E. Miola, R. Craighero, F.D. Piccolo, C. Antona, L. Brollo, M. Franchin, U. Cillo, C.
Merke, A. Gatta, Alimentary Pharmacology & Therapeutics (2006)

PRODUCTION AND SAFETY

Five different steps have been validated for their ability to remove/inactivate viruses. Four steps are
part of the Cohn fractionation method while a specific step of pasteurization has been added.
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 60C for 10h (pasteurization)

Product information abridged from the Italian Summary of Product Characteristics (SPC).
As not all the information provided applies to your country, please refer to your local SPC.

UMAN ALBUMIN

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