Octaplex 500 IU, powder and solvent for solution for infusion

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Disponible desde:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

Código ATC:

B02BD01

Designación común internacional (DCI):

PROTEIN C 13 - 31 IU/ml HUMAN COAGULATION FACTOR II 14-38 IU/ml HUMAN COAGULATION FACTOR IX 25 IU/ml HUMAN COAGULATION FACTOR VII 9 -24 IU/ml HUMAN COAGULATION FACTOR X 18 - 30 IU/ml PROTEIN S 12 - 32 IU/ml

formulario farmacéutico:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Composición:

PROTEIN C 13 - 31 IU/ml HUMAN COAGULATION FACTOR II 14-38 IU/ml HUMAN COAGULATION FACTOR IX 25 IU/ml HUMAN COAGULATION FACTOR VII 9 -24 IU/ml HUMAN COAGULATION FACTOR X 18 - 30 IU/ml PROTEIN S 12 - 32 IU/ml

tipo de receta:

POM

Área terapéutica:

ANTIHEMORRHAGICS

Estado de Autorización:

Authorised

Fecha de autorización:

2023-08-10

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAPLEX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Human prothrombin complex
OCTAPLEX 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Human prothrombin complex
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 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Octaplex is and what it is used for
2. What you need to know before you use Octaplex
3. How to use Octaplex
4. Possible side effects
5. How to store Octaplex
6. Contents of the pack and other information
1.
WHAT OCTAPLEX IS AND WHAT IT IS USED FOR
Octaplex belongs to a group of medicines called clotting factors. It
contains the human vitamin
K dependent blood coagulation factors II, VII, IX and X.
Octaplex is used to treat and prevent bleeding:
•
caused by medicines called vitamin K antagonists (such as warfarin).
These medicines
block the effect of vitamin K and cause a shortage of the vitamin K
dependent clotting
factors in your body. Octaplex is used when rapid correction of the
shortage is required.
•
in people born with a shortage of the vitamin K dependent clotting
factors II and X. It is
used when purified specific clotting factor product is not available.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAPLEX
OCTAPLEX MUST NOT BE USED:
•
if you are allergic to one of the ingredients of this product (listed
in section 6).
•
if you are allergic to heparin or if heparin has ever caused a
reduction in the level of platelets
in your blood.
•
if you have IgA deficiency with known antibodies ag

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OCTAPLEX
500 IU,
powder and solvent for solution for infusion
OCTAPLEX
1000 IU,
powder and solvent for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Octaplex is presented as a powder and solvent for solution for
infusion containing human prothrombin
complex. Octaplex nominally contains:
NAME OF INGREDIENT
OCTAPLEX 500 IU
QUANTITY PER 20 ML
VIAL
(IU)
OCTAPLEX 1000 IU
QUANTITY PER 40 ML
VIAL
(IU)
OCTAPLEX
QUANTITY AFTER
RECONSTITUTION WITH
WATER FOR INJECTIONS
(IU/ML)
_Active substances _
Human coagulation
factor II
280 - 760
560 - 1520
14 - 38
Human coagulation
factor VII
180 - 480
360 - 960
9 - 24
Human coagulation
factor IX
500
1000
25
Human coagulation
factor X
360 - 600
720 - 1200
18 - 30
_Further active ingredients _
Protein C
260 - 620
520 - 1240
13 - 31
Protein S
240 - 640
480 - 1280
12 - 32
The total protein content per vial is 260 - 820 mg (500 IU vial)/ 520
– 1640 mg (1000 IU vial). The
specific activity of the product is ≥ 0.6 IU/mg proteins, expressed
as factor IX activity.
Excipients known to have a recognised action or effect: sodium (75 -
125 mg per 500 IU vial/ 150 –
250 mg per 1000 IU vial),
heparin (100 - 250 IU per 500 IU vial/ 200 – 500 IU per 1000 IU
vial, corresponding to 0.2 - 0.5 IU/IU
FIX).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
The powder is of bluish-white colour.
The solvent is a clear and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
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
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antagonists, or in case of overdose of vitamin K antagonists, when
rapid correction of the deficiency
is required.
-
Treatment of bleeding and perioperative prophylaxis in congenital
deficiency of the vitamin K
dependent coagulation factors II an