OCTAPLEX 1000 International Unit Pdr+Solv for soln for Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
17-11-2017
Summary of Product characteristics
(SPC)
17-11-2017
Active ingredient:
HUMAN COAGULATION FACTOR II, HUMAN COAGULATION FACTOR VII, HUMAN COAGULATION FACTOR IX, HUMAN COAGULATION FACTOR X, PROTEIN C, PROTEIN S
Available from:
Octapharma Limited
ATC code:
B02BD01
INN (International Name):
HUMAN COAGULATION FACTOR II, HUMAN COAGULATION FACTOR VII, HUMAN COAGULATION FACTOR IX, HUMAN COAGULATION FACTOR X, PROTEIN C, P
Dosage:
1000 International Unit
Pharmaceutical form:
Pdr+Solv for soln for Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Blood coagulation factors
Authorization status:
Authorised
Authorization date:
2015-11-13
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAPLEX 500 IU coagulation factor IX per vial, powder and solvent
for solution for infusion – Human prothrombin complex
OCTAPLEX 1000 IU coagulation factor IX per vial, 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 do 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 bl
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Octaplex 1000 IU coagulation factor IX per vial,
powder and solvent for solution for infusion
Human Prothrombin Complex
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Octaplex is presented as a powder and solvent for solution for
infusion containing human prothrombin complex.
Octaplex nominally contains:
The total protein content per vial is 520 - 1640 mg. 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 (150 -
250 mg per vial), heparin (200 - 500 IU per 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 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 and X when purified specific coagulation factor product is
not available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
NAME OF INGREDIENT
OCTAPLEX
QUANTITY PER VIAL
(IU)
OCTAPLEX
QUANTITY AFTER RECONSTITUTION WITH 40
ML OF WATER FOR INJECTIONS
(IU/ML)
_Active substances_
Human coagulation factor II
560 -1520
14 - 38
Human coagulation factor VII
360 – 960
9 - 24
Human coagulation factor IX
1000
25
Human coagulation factor X
720 - 1200
18 - 30
_Further active ingredients_
Protein C
520 - 1240
13 - 31
Protein S
480 - 1280
12 - 32
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