Haemoctin SDH 1000
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-12-2022
Summary of Product characteristics
(SPC)
26-06-2023
Active ingredient:
FACTOR VIII, HUMAN
Available from:
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
ATC code:
B02BD02
INN (International Name):
FACTOR VIII, HUMAN 100 IU/ml
Pharmaceutical form:
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Composition:
FACTOR VIII, HUMAN 100 IU/ml
Prescription type:
POM
Therapeutic area:
ANTIHEMORRHAGICS
Authorization status:
Authorised
Authorization date:
2010-04-27
Patient Information leaflet
page 1/9
PACKAGE LEAFLET: INFORMATION FOR THE USER
HAEMOCTIN SDH 250
HAEMOCTIN SDH 500
HAEMOCTIN SDH 1000
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
HUMAN PLASMA DERIVED 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, pharmacist or
nurse.
•
This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Haemoctin SDH is and what it is used for
2. What you need to know before you use Haemoctin SDH
3. How to use Haemoctin SDH
4. Possible side-effects
5. How to store Haemoctin SDH
6. Contents of the pack and other information
1.
WHAT HAEMOCTIN SDH IS AND WHAT IT IS USED FOR
Haemoctin SDH is a medicine derived from human plasma. It contains the
coagulation factor VIII,
which is necessary for a normal course of blood coagulation. After
reconstitution of the powder with
water for injections the solution is ready for intravenous injection.
Haemoctin SDH is used for treatment and prophylaxis of bleeding in
patients with haemophilia A
(congenital factor VIII deficiency).
Haemoctin SDH does not contain von Willebrand factor in
pharmacologically effective quantities, and
is therefore not suitable for the treatment of von Willebrand's
disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE HAEMOCTIN SDH
DO NOT USE HAEMOCTIN SDH,
•
if you are allergic to coagulation factor VIII or to any of the other
ingredients of this medicine
(listed in section 6). An allergic reaction may include rash, itching,
difficulty breathing or swelling
of the face, lips, throat or tongue.
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WARNINGS AND PRECAUTIONS
The formation of inhibitors (antibodies) is a known com
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Summary of Product characteristics
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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Haemoctin SDH 250
Haemoctin SDH 500
Haemoctin SDH 1000
Powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human plasma derived coagulation factor VIII
One vial contains nominally 250, 500 or 1000 IU human plasma derived
coagulation factor
VIII.
Haemoctin SDH 250 contains approximately 250 IU (50 IU/ml) human
coagulation factor
VIII after reconstitution.
Haemoctin SDH 500 contains approximately 500 IU (100 IU/ml) human
coagulation factor
VIII after reconstitution.
Haemoctin SDH 1000 contains approximately 1000 IU (200 IU/ml) human
coagulation factor
VIII after reconstitution.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic factor VIII
coagulation assay. The specific activity of Haemoctin SDH is
approximately 100 IU/mg
protein.
Produced from the plasma of human donors.
Excipient with known effect:
One vial contains up to 32.2 mg sodium (1.4 mmol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White powder and clear, colourless solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII
deficiency).
This preparation does not contain von Willebrand factor in
pharmacologically effective
quantities and is therefore not indicated in von Willebrand´s
disease.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be 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, demonstrating different
half-lives and recoveries.
Dose based on bodyweight may require adjustment in u
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