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INNOHEP 10 000 IU/ML SYRINGE

Active substance(s): TINZAPARIN SODIUM

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Transcript
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
when 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 OUT OF THE SIGHT AND REACH OF
CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date which is stated
on the syringe label and carton. The expiry date
is the last day of the month.
• If your doctor tells you to stop using this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
• If your medicine becomes discoloured or shows
any signs of deterioration, ask your pharmacist
who will advise you what to do.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Contents of pack and other information
What innohep® contains
• The active ingredient is tinzaparin sodium.
3,500 anti-Factor Xa IU in each 0.35ml unit dose
syringe.
4,500 anti-Factor Xa IU in each 0.45ml unit dose
syringe.
• Other ingredients: sodium acetate and water for
injections. As pH adjuster: Sodium hydroxide.
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 clear, colourless to straw coloured
liquid, free of particles.
Innohep® comes in glass syringe containing
0.35ml or 0.45ml.
Each carton contains 10 syringes.
Manufacturer and Licence Holder
This medicine is manufactured by Leo
Pharmaceutical Hellas S.A., Av. Kymi & Seneca
10-14564 Kifisia, Greece and is procured from
within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 15184/1472 - Innohep 10,000 IU/ml Syringe.
Innohep is a registered trademarks of the LEO
Pharma A/S.
Leaflet revision date: 28/05/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET
Innohep ® 10,000 IU/ml Syringe

Ref: 1472/280515/1/F

(tinzaparin sdodium)
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.
Your medicine is called Innohep® 10,000 IU/ml
Syringe but will be referred to as Innohep®
throughout the rest of this leaflet.
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 pack and other information
1. What Innohep® is and what it is used for
Innohep® is a type of heparin – a low molecular
weight heparin – and belongs to a group of
medicines called anticoagulants; these medicines
affect how the blood clots. innohep prevents
clotting, allowing normal blood flow through the
arteries and veins.
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).
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).
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®”.
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®.
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.
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
ivaroxaban, 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.
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.

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.
How to inject yourself with innohep®
You should inject yourself exactly as you have
been shown and only on the parts of your body
that you have been told it is safe to inject into. The
type of injection you will be giving is known as a
subcutaneous injection. The injection goes into a
pinched up fatty layer on your abdomen or on the
outer part of your thighs. Keep away from your
belly button. Do NOT inject into a muscle.

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.

10.The used syringe, even when the orange
safety device is in place, should be handled
with care and should be disposed of in a
“sharps” container (i.e. a special bin for
needles) immediately. If a “sharps” container is
not readily available then please put the used
syringe back into the plastic container and close
the lid by pressing down on the lid until it clicks
into the slot provided. Dispose of the syringe
carefully, as instructed by your healthcare
professional. Never put syringes or needles
in the household rubbish.

When giving yourself an injection, make sure
you:
1. Thoroughly wash and dry your hands.
2. Sit, stand or lie in a position so that you can see
the skin where you are going to inject yourself.
This can comfortably be done standing up, or if
you prefer, in a lounge chair, recliner or bed
propped up with pillows.
5. Hold the syringe in your writing-hand like you
would hold a pen. With your other hand, make
a fold of your skin by gently pinching the area
where you are going to inject yourself with your
thumb and forefinger.
6. With the syringe at a right angle to your body
(pointing straight, not at an angle), insert the
needle fully into the skin fold.
7. Continue to hold the skin fold, press down on
the plunger slowly over 10-15 seconds. This
delivers this medicine into the fatty tissue.

3. How to use Innohep®

Always use this medicine exactly as your doctor,
pharmacist or nurse has told you. Check with one
of them if you are not sure that you understand
how to do the injection or if you are unsure about
anything else to do with the medicine.

Carefully take the syringe out of its plastic
container by bending the cap all the way back and
sliding the syringe out. Bend the orange safety
device down away from the cap on the needle.
Remove the protective needle cap without bending
the needle. To keep the needle clean, make sure it
does not touch anything. The syringe is now ready
for use.

Ideally you should inject at the same time every
day; this helps to maintain a steady level of the
medicine in your body.

Important information about some of the
ingredients of innohep®
Innohep® syringe contains:
• 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.

Your doctor may decide that you or a carer may
inject this medicine. You will be shown how to do
the injection and should only do the injection when
you have been instructed how to do so.

9. Using a hard surface, bend the orange safety
device so it is now pointing in the same
direction as the needle (back to its original
position). Then with the safety device flat
against a hard surface such as a table, gently
push downwards until the needle clicks into the
device. Then continue to push downwards
against the hard surface, so that the needle and
device are at a 45 degree angle to the syringe.

To prevent harmful blood clots forming in your
veins after an operation
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®.

3. Decide where to inject yourself. This is usually
on the right or left side of the abdomen
remembering not to inject yourself within 5 cm
(2 inches) of your belly button. You may also
inject into the sides of your thigh. Do not inject
near any scars or bruises. Each time you inject
yourself, choose the opposite side from the site
of your previous injection. So if you injected
your right thigh last time, you would inject your
left thigh next time. If you are injecting in your
abdomen, you would do the left side one day
and right the next. You should also avoid
injecting into the exact site of a previous
injection.
4. Clean the chosen area of the skin, as you have
been told to do by your doctor or nurse, and
allow to dry before you inject yourself.

8. Pull the needle completely out of the skin and
then let go of the skin fold. Do not rub or
massage the place where you injected yourself
– this can lead to bruising.

For the attention of the healthcare
professional:
Please dispose of the used syringe in accordance
with your institution/employer’s standard
procedures for disposal of used syringes.
If you use more innohep® than you should
If you think you may have injected yourself with
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 forget to have your injection, 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 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.

Ref: 1472/280515/1/B

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
when 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 OUT OF THE SIGHT AND REACH OF
CHILDREN.
• Do not store above 25°C.
• Do not use after the expiry date which is stated
on the syringe label and carton. The expiry date
is the last day of the month.
• If your doctor tells you to stop using this
medicine, take any remaining medicine back to
the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
• If your medicine becomes discoloured or shows
any signs of deterioration, ask your pharmacist
who will advise you what to do.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Contents of pack and other information
What innohep® contains
• The active ingredient is tinzaparin sodium.
3,500 anti-Factor Xa IU in each 0.35ml unit dose
syringe.
4,500 anti-Factor Xa IU in each 0.45ml unit dose
syringe.
• Other ingredients: sodium acetate and water for
injections. As pH adjuster: Sodium hydroxide.
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 clear, colourless to straw coloured
liquid, free of particles.
Innohep® comes in glass syringe containing
0.35ml or 0.45ml.
Each carton contains 10 syringes.
Manufacturer and Licence Holder
This medicine is manufactured by Laboratoires
Leo S.A., France and is procured from within the
EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 15184/1472 - Innohep 10,000 IU/ml Syringe.
Innohep is a registered trademarks of the LEO
Pharma A/S.
Leaflet revision date: 28/05/15

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET
Innohep ® 10,000 IU/ml Syringe

Ref: 1472/280515/2/F

(tinzaparin sdodium)
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.
Your medicine is called Innohep® 10,000 IU/ml
Syringe but will be referred to as Innohep®
throughout the rest of this leaflet.
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 pack and other information
1. What Innohep® is and what it is used for
Innohep® is a type of heparin – a low molecular
weight heparin – and belongs to a group of
medicines called anticoagulants; these medicines
affect how the blood clots. innohep prevents
clotting, allowing normal blood flow through the
arteries and veins.
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).
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).
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®”.
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®.
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.
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
ivaroxaban, 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.
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.

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.
How to inject yourself with innohep®
You should inject yourself exactly as you have
been shown and only on the parts of your body
that you have been told it is safe to inject into. The
type of injection you will be giving is known as a
subcutaneous injection. The injection goes into a
pinched up fatty layer on your abdomen or on the
outer part of your thighs. Keep away from your
belly button. Do NOT inject into a muscle.

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.

10.The used syringe, even when the orange
safety device is in place, should be handled
with care and should be disposed of in a
“sharps” container (i.e. a special bin for
needles) immediately. If a “sharps” container is
not readily available then please put the used
syringe back into the plastic container and close
the lid by pressing down on the lid until it clicks
into the slot provided. Dispose of the syringe
carefully, as instructed by your healthcare
professional. Never put syringes or needles
in the household rubbish.

When giving yourself an injection, make sure
you:
1. Thoroughly wash and dry your hands.
2. Sit, stand or lie in a position so that you can see
the skin where you are going to inject yourself.
This can comfortably be done standing up, or if
you prefer, in a lounge chair, recliner or bed
propped up with pillows.
5. Hold the syringe in your writing-hand like you
would hold a pen. With your other hand, make
a fold of your skin by gently pinching the area
where you are going to inject yourself with your
thumb and forefinger.
6. With the syringe at a right angle to your body
(pointing straight, not at an angle), insert the
needle fully into the skin fold.
7. Continue to hold the skin fold, press down on
the plunger slowly over 10-15 seconds. This
delivers this medicine into the fatty tissue.

3. How to use Innohep®

Always use this medicine exactly as your doctor,
pharmacist or nurse has told you. Check with one
of them if you are not sure that you understand
how to do the injection or if you are unsure about
anything else to do with the medicine.

Carefully take the syringe out of its plastic
container by bending the cap all the way back and
sliding the syringe out. Bend the orange safety
device down away from the cap on the needle.
Remove the protective needle cap without bending
the needle. To keep the needle clean, make sure it
does not touch anything. The syringe is now ready
for use.

Ideally you should inject at the same time every
day; this helps to maintain a steady level of the
medicine in your body.

Important information about some of the
ingredients of innohep®
Innohep® syringe contains:
• 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.

Your doctor may decide that you or a carer may
inject this medicine. You will be shown how to do
the injection and should only do the injection when
you have been instructed how to do so.

9. Using a hard surface, bend the orange safety
device so it is now pointing in the same
direction as the needle (back to its original
position). Then with the safety device flat
against a hard surface such as a table, gently
push downwards until the needle clicks into the
device. Then continue to push downwards
against the hard surface, so that the needle and
device are at a 45 degree angle to the syringe.

To prevent harmful blood clots forming in your
veins after an operation
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®.

3. Decide where to inject yourself. This is usually
on the right or left side of the abdomen
remembering not to inject yourself within 5 cm
(2 inches) of your belly button. You may also
inject into the sides of your thigh. Do not inject
near any scars or bruises. Each time you inject
yourself, choose the opposite side from the site
of your previous injection. So if you injected
your right thigh last time, you would inject your
left thigh next time. If you are injecting in your
abdomen, you would do the left side one day
and right the next. You should also avoid
injecting into the exact site of a previous
injection.
4. Clean the chosen area of the skin, as you have
been told to do by your doctor or nurse, and
allow to dry before you inject yourself.

8. Pull the needle completely out of the skin and
then let go of the skin fold. Do not rub or
massage the place where you injected yourself
– this can lead to bruising.

For the attention of the healthcare
professional:
Please dispose of the used syringe in accordance
with your institution/employer’s standard
procedures for disposal of used syringes.
If you use more innohep® than you should
If you think you may have injected yourself with
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 forget to have your injection, 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 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.

Ref: 1472/280515/2/B

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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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