INNOHEP SYRINGE 10 000 IU/ML

Active substance: TINZAPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
Subject

Preparation
Strength

Rev. No.

Sent by e-mail

XX

025876
Date

5.

Date

Date

Sign.

Sign.

INS 410 x 315 mm (205 x 315 mm with 2 foils) 05/12/14
Colour

Sign.

OMA

Black

Supplier / Place of production

innohep® syringe 10,000 IU/ml

France

Comments:

Page 1 of 2

font 9 pt and lines space 3,35 mm

Only for 10 syringes

EBD
19/12/14

Mock-up for reg. purpose

Page 4 of 4

Page 1 of 4
5 mm

5 mm

Package leaflet: Information for the user

025876-XX

9 mm

Industriparken 55 – DK-2750 – Ballerup

Item No.

GB



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

Get-up

100%

016446XX

Scale

01644610

ARTWORK

34 mm

syringe 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 syringe 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 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 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.

innohep is used 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).

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.

2. What you need to know before you use innohep®

10 mm

10 mm

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.

Children
innohep is not recommended for use in children.

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
10 mm
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).

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.

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.

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.
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.

5 mm

5 mm

185 mm

185 mm

10 mm

Scale

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

Subject

Industriparken 55 – DK-2750 – Ballerup
Preparation
Strength

Get-up

Item No.

100%

GB

Rev. No.

Sent by e-mail



ARTWORK

XX

025876
Date

Date

Date

Sign.

Sign.

INS 410 x 315 mm (205 x 315 mm with 2 foils) 05/12/14
Colour

Sign.

OMA

Black

Supplier / Place of production

innohep® syringe 10,000 IU/ml

France

Comments:

Page 2 of 2

Page 2 of 4

Page 3 of 4
5 mm

3. How to use

innohep®

5 mm

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.

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.

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.

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.

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
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
There is no experience of use in children.

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.

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.

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.

What innohep contains
• The active substance is tinzaparin sodium.
• innohep syringe 10,000 IU/ml contains 10,000 IU of tinzaparin
sodium in each millilitre (ml).
• The other ingredients are sodium acetate, sodium hydroxide
and water for injections.

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.

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 glass syringe containing 0.25 ml, 0.35 ml or
0.45 ml.
There are 5, 10, 50 or 100 syringes in a carton.
Not all pack sizes may be marketed.

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.
10 mm 10 mm

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.

6.Contents of pack and other information

Important side effects to look out for:

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.

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
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.

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.

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.

When giving yourself an injection, make sure you:
10 mm

• Keep this medicine out of the sight and reach of children.
• Do not use the 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.

4.Possible side effects

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.

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

5.How to store innohep®

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.

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.

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.

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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: LEO Laboratories Limited,
Hurley, Berkshire SL6 6RJ, UK.
Manufacturer: Laboratoires LEO, 28500 Vernouillet, France.
10 mm

This leaflet was last revised in December 2014.

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.

® Registered Trade Mark

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.

5 mm

5 mm

185 mm

185 mm

LEO
025876-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
(web2)