| Haemoctin®
SDH/ Factor VIII Biotest SDH |
|
Human blood clotting factor VIII |
|
 Composition:
One pierceable vial Haemoctin® SDH 250/500/1,000
contains 250/500/1,000 IU of human clotting
factor VIII. After reconstitution the
dry human clotting factor VIII. After
reconstitution the dry substance in 5/10/10
ml of water for injection, each ml of
product contains about 50/50/100 IU of
human clotting factor VIII. The specific
activity of Haemoctin® SDH
250/500/1,000 is about 50-170 IU/mg protein.
Other ingredients: Glycine, Sodium, chloride,
calcium chloride. |
|
Indications: Prophylaxis and treatment
of bleeding haemophilia A (congenital
deficiency of factor VIII) and acquired
factor VIII deficiency. Treatment of patients
with factor VIII neutralising antibodies
(=inhibitors). |
|
Contra-indication : Haemoctin®
SDH 250/500/1,000 should not be used in
hypersensitivity to blood clotting factor
VIII or to any other constituents. |
|
Special
Precautions for use: As with any intravenous
protein product, allergic type hypersensitivity
reactions are possible. The product contains
traces of human proteins other than factor
VIII. Patients should be informed of the
early signs of hypersensitivity reactions
including hives, Generalised urticaria,
tightness of the chest, wheezing, hypotension,
and anaphylaxis. If these symptoms accur,
they should be advised to discontinue
use of the product immediately and contact
their physician. |
|
In
case of shock, the current medical standards
for shock-treatment should be observed. |
|
Dosage
instructions and duration of application:
the dosage depends on the severity of
the clotting disturbance, on the location
and extent of the bleeding and on the
clinical condition of the patients. |
|
Interactions with other medicinal products:
Interactions between Haemoctin®
SDH 250/500/1000 and other medicinal products
are unknown. |
|
Method
of administration: The product should
be administered via the intravenous route.
It is recommended not to administer more
than 2-3 ml/min. |
|
Special
precaution for storage: Do not store
above 25 oC. Do not freeze. Keep the container
in the outer carton in order to protect
from light. |
|
Presentations: Haemoctin®
SDH 250, Haemoctin® SDH 500
and Haemoctin®SDH 1,000 |
|
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