INNOHEP 10,000 IU IN 0.5 ML
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
04-03-2017
Summary of Product characteristics
(SPC)
04-03-2017
Active ingredient:
TINZAPARIN SODIUM
Available from:
PCO Manufacturing
ATC code:
B01AB10
INN (International Name):
TINZAPARIN SODIUM
Dosage:
20000 IU/ML
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
tinzaparin
Authorization status:
Authorised
Authorization date:
2014-04-04
Patient Information leaflet
_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOHEP
® 10,000 IU IN 0.5 ML
INNOHEP
® 14,000 IU IN 0.7 ML
INNOHEP
® 18,000 IU IN 0.9 ML
SOLUTION FOR INJECTION (20,000 IU/ML)
tinzaparin sodium
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.
–
In this leaflet the innohep
®
syringe 20,000 IU/ml presentations listed above will be
called innohep
®
.
WHAT IS IN THIS LEAFLET:
1.
What innohep
®
is and what it is used for.
2.
What you need to know before you use innohep
®
.
3.
How to use innohep
®
.
4.
Possible side effects.
5.
How to store innohep
®
.
6.
Contents of the pack and other information.
1.
WHAT INNOHEP
® IS AND WHAT IT IS USED FOR
innohep
®
belongs to a group of medicines called low molecular weight heparins
which
help to stop the blood from clotting.
innohep
®
is used in adults to treat:
Harmful blood clots that have formed in a vein deep inside your body.
This is usually in your leg (deep vein thrombosis or DVT for short).
Harmful blood clots that have formed may travel in your bloodstream
and then get
stuck in another blood vessel (thromboembolism). A clot may block the
blood
supply to your lungs (pulmonary embolism or PE for short). It can
cause breathing
difficulties.
Blood clots that have developed because of cancer and to prevent
further clots
from forming.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE INNOHEP
®
✖
DO NOT USE INNOHEP
®
If you are allergic (hypersensitive) to tinzaparin or any of the other
ingredients in
your medicine. You can find a list of these in
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
innohep 10,000 IU in 0.5 ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tinzaparin sodium 20,000 anti-Factor Xa IU/mL.
Excipients with known effect: Sodium metabisulphite.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
_Product imported from Greece_
Colourless or slightly yellow aqueous solution.
4 CLINICAL PARTICULARS
PA0046/060/010
5 PHARMACOLOGICAL PROPERTIES
PA0046/060/010
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium metabisulfite
Sodium hydroxide (for pH-adjustment)
Water for injections
6.2 INCOMPATIBILITIES
In the absence of compatibility studies, this medicinal product must
not be mixed with other medicinal products.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
Any portion of the contents not used at once should be discarded. The
liquid may turn yellow in storage but this does
not affect product quality.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
For storage conditions after first opening of the medicinal product,
see section 6.3.
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6.5 NATURE AND CONTENTS OF CONTAINER
Glass syringe contains 0.5ml so
Read the complete document
