Emoclot 500 IU Lyophilized Powder for Injection (IV)

Država: Filipini

Jezik: engleski

Izvor: FDA (Food And Drug Administration)

Aktivni sastojci:

Human Plasma Coagulation Factor VIII

Dostupno od:

N/A; Importer: New Marketlink Pharmaceutical Corporation; Distributor: Metro Drug Inc.

INN (International ime):

Human Plasma Coagulation Factor VIII

Doziranje:

500 IU

Farmaceutski oblik:

Lyophilized Powder for Injection (IV)

Jedinice u paketu:

Type I glass vial + 10 mL diluent (Water for Injection) in a box, Type I glass vial + 10mL diluent (Water for Injection) in a bo

Proizveden od:

Kedrion S.p.A, Italy

Datum autorizacije:

2022-10-06

Uputa o lijeku

_EMOCLOT- PIL-St.Eng-K17 _
_1 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
EMOCLOT 500 IU/10 ML POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
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)
_EMOCLOT- PIL-St.Eng-K17 _
_2 _
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 follow

Svojstava lijeka

_This is a translation of the Italian Summary of Product
Characteristics (SPC). _
_As not all the information given applies to your country, please
refer to your local SPC._
_ _
_ 1 _
_ _
_ _
_EMOCLOT-SPC-StdEng-K17 _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
EMOCLOT 500 IU/10 ml Powder and solvent for solution for infusion
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 500 IU or 1000 IU of human coagulation
factor VIII.
EMOCLOT contains approximately 500 IU/10 ml or 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
500 IU/10 ML
EMOCLOT
1000 IU/10 ML
human plasma coagulation factor VIII
500 IU/vial
1000 IU/vial
human
plasma
coagulation
factor
VIII
reconstituted with water for injections
50 IU/ ml
(500 IU/10 ml)
100 IU/ ml
(1000 IU/10 ml)
solvent volume
10 ml
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.
_This is a translation of the Italian Summary of Product
Characteristics (SPC). _
_As not all the information given applies to your country, please
refer to your local SPC._
_ _
_ 2 _
_ _
_ _
_EMOCLOT-SPC-StdEng-K17 _
The medicinal product is a white or pale yellow, hygroscopic powder or
friable solid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital Factor
VIII deficiency).
Management of acquired Factor VIII deficiency.
Treatme