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INNOHEP 10 000 IU/ML

Active substance(s): TINZAPARIN SODIUM

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Item No.

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Rev. No.

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031278
Date

INS 120 x 320 mm

Date

Date

16/02/15

Colour

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

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JUG

Black

Supplier / Place of production

innohep® 10,000 IU/ml vials

Denmark

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Page 1 of 2

Font size: Heading: 10 point, section: 9 point, linespacing: 3 mm

Mock-up for registration purpose.

Innohep Hætteglas
120 mm

Package leaflet: Information for the user

10,000 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 innohep 10,000 IU/ml will be called innohep.

031278-XX

20 mm
(centred)

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 of this medicine; you
can find a list of ingredients in section 6 of this
leaflet.
• If you have ever had a reaction to heparin that
caused a severe drop in the number of your
clotting cells (platelets) - this reaction is called
heparin-induced thrombocytopenia (HIT).
• If you have ever had a major bleed (for instance:
in the brain, spine, eye or stomach, into a muscle
or the womb, or any conditions which make you
bleed severely, such as haemophilia).
• If you have a condition called septic endocarditis
(an inflammation of the lining of the heart and
heart valves).
Do not give this medicine to a premature baby, a
newborn baby or a baby up to 1 month old as it
contains benzyl alcohol (see “Important information
about some of the ingredients of innohep” below).
The use of innohep vials should be avoided if you
are pregnant or think you may be pregnant due to
the presence of benzyl alcohol. (see “Pregnancy
and breast-feeding”)
Warnings and precautions
Important: If you are having an epidural/spinal
anaesthetic
Your doctor will decide if you can have an
epidural/spinal anaesthetic if you are using innohep.
You must wait 12 hours after your last injection of
innohep before having a lumbar puncture or
epidural/spinal anaesthetic placed.
You must wait at least 4 hours after having a spinal
anaesthetic, or after the catheter has been
removed, before you start using innohep again.
If you have an anaesthetic your doctor or nurse will
make regular checks. This is to check if you are
getting any major bleeding or bruising around your
spine. This may cause paralysis that could be
permanent. Any signs this may be happening to you
include tingling, weakness or numbness in your
lower legs or body, back pain or problems in going
to the toilet. This happens very rarely.
You may have a blood test before you start using
this medicine and at intervals while you are using it;
this is to check the level of the clotting cells (platelets)
and potassium in your blood.
Do not inject innohep into a muscle. See section 3,
“How to use innohep®”.

innohep should not be interchanged with other low
molecular weight heparin products. This is because
they are not exactly the same and you could
experience problems with your blood clotting.
Elderly people
Because kidney problems are more likely if you are
elderly, you may have a blood test to check how
well your kidneys are working and to monitor the
activity of innohep.
Children and adolescents
innohep is not intended for use in children and
adolescents under the age of 18 years.
Other medicines and innohep
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes any medicines bought
without a prescription.
You must tell your doctor or pharmacist if you are
taking any of the following medicines as you may
be likely to bleed more easily:
• Non-steroidal anti-inflammatory drugs (such as
ibuprofen or diclofenac): for arthritis or aches or
pains.
• Aspirin: either for reducing pain and inflammation,
or the lower dose for thinning of the blood.
• Platelet aggregation inhibitors (such as
clopidogrel): for stopping harmful blood clots
forming.
• Thrombolytic agents (such as streptokinase):
for dissolving blood clots.
• Vitamin K antagonists (such as warfarin): for
stopping harmful blood clots.
• Activated protein C: for getting rid of blood clots
• Anticoagulation, taken by mouth (such as
rivaroxaban, dabigatran or apixaban): for
stopping harmful blood clots.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor, pharmacist or midwife for advice
before using this medicine.
The use of innohep vials should be avoided if you
are pregnant or think you are pregnant due to the
presence of benzyl alcohol. Your doctor will
prescribe a different formulation of innohep.
Special precautions are required if you will have an
epidural anaesthetic to help you with your labour
when you are using innohep.
(See "Warnings and Precautions").
Driving and using machines
This medicine should not have any effect on your
ability to drive or use machines. However, you
should check with your doctor if you feel any side
effect that may stop you from driving or using
machines.

20/02/15

innohep is used in adults to help stop:
• Harmful blood clots forming in your veins
following an operation. An example is a clot in a
deep vein (deep vein thrombosis, DVT). This
usually occurs in a leg.
• Harmful blood clots forming in the tubing of an
artificial kidney machine during kidney dialysis
(haemodialysis).

JUG

189 mm

innohep is a type of heparin – a low molecular
weight heparin – and belongs to a group of
medicines called anticoagulants; these medicines
affect how your blood clots.
innohep prevents clotting, allowing normal blood
flow through the arteries and veins.

Talk to your doctor, pharmacist or nurse before
using innohep
• If you are pregnant, or think you may be pregnant.
See the section “Pregnancy and breast-feeding”.
• If you have a condition which makes you more
likely to bleed.
• If you are being treated with any other injections
into your muscles.
• If you are allergic (hypersensitive) to heparin.
• If you are allergic to other low molecular weight
heparins, such as enoxaparin or dalteparin.
• If you have any medical condition such as
diabetes mellitus or metabolic acidosis which
may cause high levels of potassium in your blood
(hyperkalaemia).
• If you have an artificial heart valve.
• If you have kidney problems.

3.

1. What innohep® is and what it is used for

This medicine may make you bleed more easily, so
when you are being given other injections or having
any procedures carried out, tell the doctor, nurse or
dentist that you are using innohep.

320 mm

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

Scale

Please return to:
LEO Pharma A/S
Internal Market Access

Subject

Item No.

GB

Sent by e-mail

XX
Date

Date

Colour

Sign.

Sign.

JUG

Black

Supplier / Place of production

innohep® 10,000 IU/ml vials

Denmark

Page 2 of 2
Innohep Hætteglas

031278-XX

189 mm

3. How to use innohep®
innohep will be given to you by your doctor or your
nurse. innohep should not be mixed with any other
injection.
How much innohep to use
Adults, including the elderly:
To prevent harmful blood clots forming in the tubing
of an artificial kidney machine during kidney
dialysis (haemodialysis)
innohep will be given either into the artificial kidney
machine or into your vein.
The usual dose depends on the length of dialysis.
To prevent harmful blood clots forming in your
veins after an operation
innohep will be given under your skin.
The usual dose depends on the type of operation
you are having.
You will have one dose of innohep before your
operation. Then usually you will have one dose of
innohep once a day for 7 to 10 days afterwards.
Your doctor will decide how long you should use
innohep.
Use in children and adolescents
There is limited experience of use in children and
adolescents. innohep is not intended for use in
children and adolescents under the age of 18 years.
If you use more innohep than you should
If you feel unwell or think you may have been given
too much, tell your doctor or nurse straight away
because you may start to haemorrhage (bleed
severely) and need to be given another injection of
a medicine called protamine sulphate to stop you
bleeding.
If you have missed a dose of innohep
If you think that you have missed a dose, it is
important that you talk to your doctor or nurse as
soon as you remember and get advice on what to do.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. The side
effects most often reported are blood problems and
skin reactions, especially where your injection has
been given.
Important side effects to look out for:
You must get urgent medical help if you have any of
the following symptoms. You may be having a
serious allergic reaction. These are rare (may
affect up to 1 in 1000 people).
• You have difficulty breathing.
• Your face or throat swell.
• Your skin develops a severe rash.
• You experience blistering of the skin, mouth, eyes
or genitals or your skin peels.
• Blood spots near the injection site which could
develop into a purple blister surrounded by red
inflamed skin.
You must get urgent medical help if you have any of
the following symptoms after having an epidural or
spinal anaesthetic. You may be developing
paralysis:
• Tingling, weakness or numbness in your legs or
lower body.
• Back pain.
• Problems in going to the toilet.
You should tell your doctor straight away if you
spot any of the following signs which mean you
may be starting to bleed severely:
• Red or brown urine.
• Black tarry stools.
• Unusual bruising.
• Bleeding from your nose, or mouth or any
operation wound that will not stop.
Common side effects (may affect up to 1 in 10 people)
• Bleeding (haemorrhage).
• Anaemia. Reduction in red blood cells which can

make the skin pale and cause weakness and
breathlessness.
• A pooling of blood in tissues which may result in
the skin appearing dark in colour, similar to a
large bruise.
• Pain, itching, bruising or bleeding, redness,
swelling, nodules or hard lumps under your skin
where the injection was given.
Uncommon side effects (may affect up to 1 in 100
people)
• Changes in your blood test results. There may be
a change in the clotting cells (platelets) in your
blood. These tests will return to normal after
innohep is stopped.
• An allergic reaction. You may be sensitive to one
of the ingredients in this medicine.
• Bruising, red or purple spots under your skin.
• Some blood tests may also show a change in the
way your liver is working. These tests will return
to normal when innohep is stopped.
• An itchy red rash with heat and swelling on your
skin (dermatitis).
• Rash.
• Itchy skin.
Rare side effects (may affect up to 1 in 1000 people)
• Your blood may form more harmful clots. A drop in
the number of clotting cells (platelets) in your
blood may give you these symptoms. Your doctor
can explain this more.
• Changes in your blood test results. The amount of
potassium may be increased. This is more likely
to happen if you have severe kidney problems or
diabetes. Your doctor can explain this more.
• Hives.
• Your bones may weaken and break more easily.
This is known as osteoporosis and has been seen
in patients using heparin for a long time.
• Prolonged, painful erections in men.
Paediatric population
Limited information derived from one study and
postmarketing data indicates that the pattern of
adverse reactions in children and adolescents is
comparable to that in adults.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store innohep®
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date
which is stated on the label (EXP). The expiry date
is the last day of that month. Any contents
remaining in the vial 14 days after first opening
should be discarded.
• Do not store above 25°C.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What innohep contains
• The active substance is tinzaparin sodium.
• Each vial contains 20,000 IU of tinzaparin sodium
in 2 millilitres (ml) of solution.
• The other ingredients are benzyl alcohol, sodium
acetate, sodium hydroxide and water for injections.
You can find important information about some of
the ingredients near the end of section 2, just
before section 3.
What innohep looks like and contents of the pack
innohep is a straw coloured liquid.
innohep comes in a glass vial containing 2 ml.
There are 1, 2, 5 or 10 vials in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: LEO Laboratories
Limited, Hurley, Berkshire SL6 6RJ, UK.
Manufacturer: LEO Pharma A/S, 55 Industriparken,
DK 2750, Ballerup, Denmark.
This leaflet was last revised in February 2015.
® Registered Trade Mark

LEO

320 mm

120 mm

Important information about some of the
ingredients of innohep
innohep vial contains:
• Benzyl alcohol. This is a preservative. It may cause
toxic and allergic reactions in infants up to 3 years
old. It must not be used in premature babies or
babies up to 1 month old. It is recommended to
use the innohep formulation without benzyl alcohol
in pregnant women. Your medicine contains
10 mg/ml of benzyl alcohol.
• Sodium. This medicine is nearly “sodium free”.
Your medicine contains less than 23 milligrams
(mg) of sodium per dose.
Please ask your doctor or pharmacist if you are
worried about any of the ingredients in this medicine.

Date

16/02/15

Comments:

20 mm
(centred)

Rev. No.

031278

INS 120 x 320 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Sign.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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