Emoclot 1000IU/10ml, powder and solvent for solution and infusion + infusion set

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

FACTOR VIII, HUMAN

Tillgänglig från:

Kedrion S.p.A Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga - Lucca, Italy

ATC-kod:

B02BD02

INN (International namn):

FACTOR VIII, HUMAN 1000 IU

Läkemedelsform:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Sammansättning:

FACTOR VIII, HUMAN 1000 IU

Receptbelagda typ:

POM

Terapiområde:

ANTIHEMORRHAGICS

Bemyndigande status:

Authorised

Tillstånd datum:

2007-04-05

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE USER
EMOCLOT 1000 IU/10 ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
HUMAN PLASMA COAGULATION FACTOR VIII
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1. What EMOCLOT is and what it is used for
2. What you need to know before you use EMOCLOT
3. How to use EMOCLOT
4. Possible side effects
5. How to store EMOCLOT
6. Contents of the pack and other information
1. WHAT EMOCLOT IS AND WHAT IT IS USED FOR.
EMOCLOT is a blood coagulation factor VIII solution derived from human
plasma. Factor VIII is a
protein which has an antihemorrhagic action.
EMOCLOT is used for:
•
treatment and prevention of bleeding in patients with a hereditary
deficiency of factor VIII activity
(haemophilia A);
•
treatment of bleeding in patients with a factor VIII activity
secondary to other diseases;
•
treatment of haemophiliac patients who have developed antibodies
against factor VIII (inhibitors)
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2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMOCLOT
DO NOT USE EMOCLOT
•
if you are allergic to human factor VIII or any of the other
ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using EMOCLOT
_Allergic reaction _
Allergic type hypersensitivity reactions are possible with EMOCLOT.
EMOCLOT contains traces of human proteins other than factor VIII.
During the administration of the
product if you notice any of the following symptoms you should
immediately stop the infusion and

Produktens egenskaper

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE
MEDICINAL
PRODUCT
EMOCLOT 1000 IU/10 ml, powder and solvent for solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human plasma coagulation Factor VIII, freeze dried.
Each vial contains nominally 1000 IU of human coagulation factor VIII.
EMOCLOT contains approximately 1000 IU/ 10 ml of human coagulation
factor VIII after
reconstitution.
EMOCLOT is presented as a powder and solvent for solution for infusion
containing
nominally:
EMOCLOT
1000 IU/10 ML
human plasma coagulation factor VIII
1000 IU/vial
human
plasma
coagulation
factor
VIII
reconstituted with water for injections
100 IU/ ml
(1000 IU/10 ml)
solvent volume
10 ml
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay.
The specific activity of EMOCLOT is approximately 80 IU/mg protein.
Produced from the plasma of human donors.
This preparation contains human von Willebrand factor.
Excipient(s) with known effect: this medicinal product contains up to
41 mg sodium per vial
of 10 ml.
For a full list of excipients, see paragraph 6.1.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
The medicinal product is a white or pale yellow, hygroscopic powder or
friable solid.
4
CLINICAL PARTICULARS
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4.1
Therapeutic indications
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital Factor VIII
deficiency).
Management of acquired Factor VIII deficiency.
Treatment of haemophiliacs with antibodies against Factor VIII
(inhibitors: see also 4.4).
4.2
Posology and method of administration
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia.
Treatment monitoring
During the course of treatment, appropriate determination of factor
VIII levels is advised to
guide the dose to be administered and the frequency of repeated
infusions. Individual patients
may vary in their response to factor VIII, demo