Skip to Content

INNOHEP SYRINGE 20 000 IU/ ML

Active substance(s): TINZAPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
Scale

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

Subject

Item No.

GB

Rev. No.

Date

Colour

Sent by e-mail

XX

031277

INS 210 x 315 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Date

Date

Sign.

Sign.

17/02/15
Sign.

JUG

Black

Supplier / Place of production

innohep® syringe 20,000 IU/ml

France

Comments:

Page 1 of 2

Pointsize: 9,0 pt

Mock-up for registration purpose.

Headings 10,0 pt

Package leaflet: Information for the user

031277-XX

syringe 20,000 IU/ml
tinzaparin sodium

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 treat:
• Harmful blood clots that have formed in a deep vein (deep vein thrombosis, DVT).
This usually occurs in a leg.
• Clots that may travel in your bloodstream and cause a blockage (a
thromboembolism).
• A clot that has travelled to the lung and caused a blockage (pulmonary embolism,
PE). This can cause breathing difficulties and chest pain.
• Blood clots that have developed because of the presence of a solid tumour (a
particular type of cancer).

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).
Important: You must not have an epidural/spinal anaesthetic within 24 hours after
your last injection of innohep. You must wait at least 4 to 6 hours after having a spinal
anaesthetic, or after the catheter has been removed, before you start using innohep
again.
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.
Warnings and precautions
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.
If you have a brain tumour, you will be monitored closely because medicines such as
innohep that prevent blood from forming clots, may cause bleeding into the skull.
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 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 a 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.
• If you have asthma, as this medicine contains sodium metabisulphite (see
“Important information about some of the ingredients of innohep” below).
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.

3. How to use innohep®
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.
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.
How much innohep to use
Adults, including the elderly:
The dose depends on your weight and this will be worked out by the doctor who
prescribes it for you. You will be told how much you need to inject. It is possible you
may not need to inject the entire contents of the syringe.
You will have one dose of innohep each day for at least 6 days.
The treatment may be continued for up to 6 months if you have a solid tumour
(a particular type of cancer).
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.
Ideally you should inject at the same time every day; this helps to maintain a steady
level of the medicine in your body.
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.
3. Decide where to inject yourself. This is
usually on the right or left side of the
abdomen, remembering not to inject 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.

17/02/15

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

• 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.
You must not have an epidural anaesthetic to help with your labour or surgery within
24 hours of your last injection of innohep.
You must wait at least 4 to 6 hours after having a spinal anaesthetic, or after the
catheter has been removed, before you start using innohep again.
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.
Important information about some of the ingredients of innohep
innohep syringe contains:
• Sodium metabisulphite. This is a preservative and can cause an allergic reaction
which may result in breathing difficulties. See section 4.
• 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.

JUG

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

2.

XX
03127700

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 20,000 IU/ml syringe will be called innohep.

Scale

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

Subject

Item No.

GB

Rev. No.

Date

Colour

Sent by e-mail

XX

031277

INS 210 x 315 mm

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

100%



ARTWORK

Date

Date

Sign.

Sign.

17/02/15
Sign.

JUG

Black

Supplier / Place of production

innohep® syringe 20,000 IU/ml

France

Comments:

Page 2 of 2

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.
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. There is no need to remove
the air bubble if you need the total quantity in the syringe for your dose.
5. IMPORTANT. If the dose you have been told to have is less than the amount in the
syringe, you will need to get rid of the extra before your injection. To do this, hold
the syringe vertically with the needle pointing upwards and gently remove the
excess by pressing the plunger into the syringe.
6. 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.
7. With the syringe at a right angle to your
body (pointing straight, not at an angle),
insert the needle fully into the skin fold.
8. Continue to hold the skin fold, press down
on the plunger slowly over 10-15 seconds.
This delivers the medicine into the fatty
tissue.

9. 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.
10. 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.
11. 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.
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 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 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 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.
• 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 pack and other information
What innohep contains
• The active substance is tinzaparin sodium.
• innohep syringe 20,000 IU/ml contains 20,000 IU of tinzaparin sodium in each
millilitre (ml).
• The other ingredients are sodium metabisulphite, 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 syringe containing:
0.4 ml (8,000 anti-Factor Xa IU),
0.7 ml (14,000 anti-Factor Xa IU),
0.5 ml (10,000 anti-Factor Xa IU),
0.8 ml (16,000 anti-Factor Xa IU), or
0.6 ml (12,000 anti-Factor Xa IU),
0.9 ml (18,000 anti-Factor Xa IU)
There are 2, 6 or 10 syringes 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: Laboratoires LEO, 28500 Vernouillet, France.
This leaflet was last revised in February 2015.
® Registered Trade Mark

LEO
031277-XX

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.

Hide