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MONOPARIN 5 000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INJECTION

Active substance(s): HEPARIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

HEPARIN SODIUM 5,000 I.U./ml solution for
injection or concentrate for solution for infusion
HEPARIN SODIUM 25,000 I.U./ml solution for
injection or concentrate for solution for infusion
Preservative Free

or have recently taken, any other medicines, including those
medicines obtained without a prescription, as some medicines
may affect the way heparin injection works. Taking some
medicines at the same time as heparin could mean you may be
likely to bleed more.

In particular, tell your doctor if you are taking any of the following:
• aspirin or other non-steroidal anti-inflammatory drugs
(e.g diclofenac or ibuprofen)
• dextran solutions (used to treat shock)
Read all of this leaflet carefully before you start taking
• medicines which may interfere with the proper clotting of the
this medicine.
blood (e.g. dipyridamole, epoprostenol, clopidogrel or
- Keep this leaflet. You may need to read it again.
streptokinase)
- If you have any further questions, please ask your doctor
• cephalosporins, used to treat infections
or nurse.
• medicines called ACE inhibitors used for high blood pressure
- This medicine has been prescribed for you. Do not pass it on
and heart failure (e.g. captopril, enalapril, lisinopril or ramapril)
to others. It may harm them, even if their symptoms are the
• medicines that may increase the potassium level in your blood
same as yours.
(e.g. amiloride, triamterene, eplerenone or spironolactone)
The name of your medicine is either heparin sodium 5,000 I.U./ml • glyceryl trinitrate given into a vein (for coronary heart disease)
• aminoglycoside antibiotics (e.g. gentamicin, amikacin,
or heparin sodium 25,000 I.U./ml solution for injection or
neomycin or tobramycin)
concentrate for solution for infusion. In the rest of this leaflet
• probenecid, used in the treatment of gout
it is called heparin injection.
In this leaflet:
1. What heparin injection is and what it is used for
2. Before you are given heparin injection
3. How heparin injection is given
4. Possible side effects
5. How to store heparin injection
6. Further information

1. WHAT HEPARIN INJECTION IS AND WHAT IT IS USED FOR
Heparin belongs to a group of drugs that are called
anticoagulants. These help to stop blood clotting. Heparin
injection is used in conditions where blood vessels may become
blocked by blood clots. It is therefore used to treat and prevent:
• blood clots in leg veins (deep vein thrombosis)
• blood clots in the lung (pulmonary embolism)
as well as for:
• the treatment of chest pains resulting from disease of the
heart arteries (unstable angina pectoris)
• the treatment of severe blockages affecting arteries in the
legs (acute peripheral arterial occlusion)
• the prevention of blood clots in the heart following a heart
attack (mural thrombosis).
It is also used during heart and lung operations and during
kidney dialysis.

If you need one of the above medicines your doctor may decide
to alter the dose of heparin injection or the other medication.
If you have any doubts about whether this medicine should be
administered then discuss things more fully with your doctor or
nurse before it is given.
Tobacco smoke can also interfere with the working of heparin
injection. You should inform your doctor if you smoke.
The presence of heparin in the blood can affect the results of
some blood tests such as thyroid tests and the levels of calcium
or some antibiotics (e.g. gentamicin) in the blood.
Pregnancy and breast-feeding
You should let your doctor or nurse know before you are given
heparin injection if you are pregnant or wish to become pregnant.
If you are being given heparin injection bleeding may be a
problem during pregnancy or after delivery. Your bones may get
thinner if you receive heparin for a long time during pregnancy.
Ask your doctor or nurse for advice if you wish to breast-feed
Driving and using machines
Heparin injection has not been reported to affect ability to drive
or operate machines.
3. HOW HEPARIN INJECTION SHOULD BE GIVEN

Your doctor or nurse will inject your dose of heparin into a vein
either all at once or over a longer period of time (usually via a drip).
Alternatively they may inject your heparin underneath your skin.
Heparin injection should not be given if you:
• are allergic to heparin or any of the other ingredients in your You may need to have blood tests if you are receiving higher
medicine, (see ‘What heparin injection contains’ section 6)
doses of heparin or if you are pregnant to check on the effects
• drink large amounts of alcohol
of your heparin treatment.
• are currently bleeding from anywhere in the body, (apart from
You may require a lower dose if you have kidney or liver disease.
your normal periods which does not stop you being given
heparin injection)
To PREVENT blood clots in leg veins (deep vein thrombosis)
• have haemophilia (a genetic disorder which may cause you
and blood clots in the lung (pulmonary embolism)
to bleed excessively) or any other bleeding problem
Adults
• have or have ever had thrombocytopenia (a serious blood
The usual dose of heparin injection in adults is 5,000 units
disorder which prevents blood from clotting properly)
injected under the skin 2 hours before your operation, followed
• bruise easily (fragile capillaries) or have lots of purple spots
by 5,000 units injected under the skin every 8-12 hours,
that look like bruises (purpura)
for 7-10 days or until you are fully able to move about.
• have very high blood pressure
• are suffering from tuberculosis (TB)
Pregnancy
• have had severe skin problems resulting from previous
During pregnancy the dosage is 5,000-10,000 units injected
heparin treatment
under the skin every 12 hours. The dose may be adjusted
• are about to have surgery of the brain, spine or eye, a lumbar according to your blood tests.
puncture or local anaesthetic nerve block, or some other
Elderly
procedure where bleeding could be a problem
Lower doses may be used in the elderly. You may need to have
• have recently had an operation
• suffer from severe liver problems which can lead to bleeding blood tests if you are elderly, to check on the effects of your
heparin treatment.
into the oesophagus (gullet)
• have bleeding into the brain.
Children
Speak to your doctor before heparin injection is given if you: No specific doses are recommended.
• are over 60 years of age
To TREAT blood clots in leg veins (deep vein thrombosis)
• have any condition which makes you likely to bleed more
and blood clots in the lung (pulmonary embolism)
easily (for example a stomach ulcer, hiatus hernia,
inflammation of the heart, problems in the back of your eye, Adults
The usual dose in adults is 5,000 units injected into a vein.
haemorrhoids (piles), a stroke, cancer or threatened
This is followed by:
miscarriage). If you are unsure, ask your doctor or nurse.
• 1,000-2,000 units/hour injected slowly into a vein
• suffer from diabetes
or
• suffer from excess acid or high levels of potassium in your
• 10,000-20,000 units 12 hourly injected under the skin
blood or are taking a medicine that may increase the
or
potassium level in your blood (e.g. amiloride, triamterene,
eplerenone or spironolactone). If any of these apply you may • 5,000-10,000 units 4 hourly injected all at once into a vein
need to have a blood test before the start of your heparin
Elderly
treatment. If you are unsure, ask your doctor or nurse
Lower doses may be used in the elderly
• have kidney or liver disease. Your doctor may decide that a
Small adults and children
lower dose is necessary
Small adults and children will be given 50 units/kg body weight
• suffer from allergies or have previously had an allergic
reaction to low molecular weight (LMW) heparin. A small test injected into a vein followed by:
• 15-25 units/kg body weight/hour injected slowly into a vein
dose of heparin sodium injection may be given first.
or
Your doctor will check your blood if you receive treatment for
• 250 units/kg body weight 12 hourly injected under the skin
longer than five days and may do other blood tests if you have
or
major surgery.
• 100 units/kg body weight 4 hourly injected all at once into
Your doctor will take particular care if:
a vein
• you have an epidural or an anaesthetic given into the spine.
To TREAT chest pains (unstable angina pectoris) and severe blood
Taking other medicines
clots in the arteries (acute peripheral arterial occlusion)
It is very important that you inform your doctor if you are taking,

2. BEFORE YOU ARE GIVEN HEPARIN INJECTION

1. NAME OF THE MEDICINAL PRODUCT
Heparin sodium 25,000 I.U./ml Solution for injection or concentrate for
solution for infusion (UK and Ireland)
Heparin sodium 5,000 I.U./ml Solution for injection or concentrate for
solution for infusion (UK only)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 25,000 I.U./ml
(5,000 I.U. in 0.2ml) (UK and Ireland)
(12,500 I.U. in 0.5ml, 25,000 I.U. in 1ml, 125,000 in 5ml) (UK only)
Heparin sodium 5,000 I.U./ml (5,000 I.U. in 1ml, 25,000 I.U. in 5ml) (UK only)
For excipients see 6.1
3. PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion
A colourless or straw-coloured liquid, free from turbidity and from matter
that deposits on standing.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylaxis of deep vein thrombosis and pulmonary embolism
Treatment of deep vein thrombosis, pulmonary embolism, unstable
angina pectoris and acute peripheral arterial occlusion.
Prophylaxis of mural thrombosis following myocardial infarction.
In extracorporeal circulation and haemodialysis.
4.2 Posology and method of administration
Route of administration
By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride
or by intermittent intravenous injection, or by subcutaneous injection.
As the effects of heparin are short-lived, administration by intravenous
infusion or subcutaneous injection is preferable to intermittent
intravenous injections.
Recommended dosage
Prophylaxis of deep vein thrombosis and pulmonary embolism
Adults:
2 hours pre-operatively:
5,000 units subcutaneously
followed by:
5,000 units subcutaneously every
8-12 hours, for 7-10 days or until the
patient is fully ambulant.
No laboratory monitoring should be necessary during low dose heparin
prophylaxis. If monitoring is considered desirable, anti-Xa assays should
be used as the activated partial thromboplastin time (APTT) is not
significantly prolonged.
During pregnancy:
5,000 - 10,000 units every 12 hours,
subcutaneously, adjusted according to
APTT or anti-Xa assay.
Elderly:
Dosage reduction and monitoring of APTT may be advisable.
Children:
No dosage recommendations.
Treatment of deep vein thrombosis and pulmonary embolism:
Adults:
Loading dose:
5,000 units intravenously (10,000 units
may be required in severe pulmonary
embolism)
Maintenance:
1,000-2,000 units/hour by intravenous
infusion, or 10,000-20,000 units 12 hourly
subcutaneously, or 5,000-10,000 units
4-hourly by intravenous injection.
Elderly:
Dosage reduction may be advisable.
Children and small adults:
Loading dose:
50 units/kg intravenously
Maintenance:
15-25 units/kg/hour by intravenous
infusion, or 250 units/kg 12 hourly
subcutaneously or 100 units/kg
4-hourly by intravenous injection
Treatment of unstable angina pectoris and acute peripheral arterial
occlusion:
Adults:
Loading dose:
5,000 units intravenously
Maintenance:
1,000-2,000 units/hour by intravenous
infusion, or 5,000-10,000 units 4-hourly
by intravenous injection.
Elderly:
Dosage reduction may be advisable.
Children and small adults:
Loading dose:
50 units/kg intravenously
Maintenance:
15-25 units/kg/hour by intravenous
infusion, or 100 units/kg 4-hourly by
intravenous injection
Daily laboratory monitoring (ideally at the same time each day, starting
4-6 hours after initiation of treatment) is essential during full-dose
heparin treatment, with adjustment of dosage to maintain an APTT value
1.5-2.5 x midpoint of normal range or control value.
Prophylaxis of mural thrombosis following myocardial infarction
Adults:
12,500 units 12 hourly subcutaneously
for at least 10 days.
Elderly:
Dosage reduction may be advisable

In extracorporeal circulation and haemodialysis
Adults:
Cardiopulmonary bypass:
Initially 300 units/kg intravenously,
adjusted thereafter to maintain the
activated clotting time (ACT) in the range
400-500 seconds.
Haemodialysis
and haemofiltration:
Initially 1,000-5,000 units,
Maintenance:
1,000-2,000 units/hour, adjusted to
maintain clotting time >40 minutes.
Heparin resistance
Patients with altered heparin responsiveness or heparin resistance may
require disproportionately higher doses of heparin to achieve the desired
effect. Also refer to section 4.4, Special warnings and precautions for use.
4.3 Contraindications
Patients who consume large amounts of alcohol, who are sensitive to
the drug, who are actively bleeding or who have haemophilia or other
bleeding disorders, severe liver disease (including oesophageal varices),
purpura, severe hypertension, active tuberculosis or increased capillary
permeability.
Patients with present or previous thrombocytopenia. The rare occurrence
of skin necrosis in patients receiving heparin contra-indicates the further
use of heparin either by subcutaneous or intravenous routes because of
the risk of thrombocytopenia. Because of the special hazard of
post-operative haemorrhage heparin is contra-indicated during surgery
of the brain, spinal cord and eye, in procedures at sites where there is a
risk of bleeding, in patients that have had recent surgery, and in patients
undergoing lumbar puncture or regional anaesthetic block.
The relative risks and benefits of heparin should be carefully assessed in
patients with a bleeding tendency or those patients with an actual or
potential bleeding site eg. hiatus hernia, peptic ulcer, neoplasm, bacterial
endocarditis, retinopathy, bleeding haemorrhoids, suspected intracranial
haemorrhage, cerebral thrombosis or threatened abortion.
Menstruation is not a contra-indication.
4.4 Special warnings and precautions for use
Platelet counts should be measured in patients receiving heparin
treatment for longer than 5 days and the treatment should be stopped
immediately in those who develop thrombocytopenia.
In patients with advanced renal or hepatic disease, a reduction in dosage
may be necessary. The risk of bleeding is increased with severe renal
impairment and in the elderly (particularly elderly women).
Although heparin hypersensitivity is rare, it is advisable to give a trial dose of
1,000 I.U. in patients with a history of allergy. Caution should be exercised
in patients with known hypersensitivity to low molecular weight heparins.
In most patients, the recommended low-dose regimen produces no
alteration in clotting time. However, patients show an individual response
to heparin, and it is therefore essential that the effect of therapy on
coagulation time should be monitored in patients undergoing major surgery.
Caution is recommended in spinal or epidural anaesthesia (risk of spinal
haematoma).
Heparin can suppress adrenal secretion of aldosterone leading to
hyperkalemia, particularly in patients such as those with diabetes mellitus,
chronic renal failure, pre-existing metabolic acidosis, a raised plasma
potassium, or taking potassium sparing drugs. The risk of hyperkalemia
appears to increase with duration of therapy but is usually reversible.
Plasma potassium should be measured in patients at risk before starting
heparin therapy and in all patients treated for more than 7 days.
Heparin resistance
There is considerable variation in individual anticoagulant responses to
heparin.
Heparin resistance, defined as an inadequate response to heparin at a
standard dose for achieving a therapeutic goal occurs in approximately
5 to 30% of patients.
Factors predisposing to the development of heparin resistance, include:
• Antithrombin III activity less than 60% of normal (antithrombin
III-dependent heparin resistance): Reduced antithrombin III activity
may be hereditary or more commonly, acquired (secondary to
preoperative heparin therapy in the main, chronic liver disease,
nephrotic syndrome, cardiopulmonary bypass, low grade
disseminated intravascular coagulation or drug induced, e.g. by
aprotinin, strogen or possibly nitroglycerin)
• Patients with normal or supranormal antithrombin III levels
(antithrombin III-independent heparin resistance)
• Thromboembolic disorders
• Increased heparin clearance
• Elevated levels of heparin binding proteins, factor VIII, von Willebrand
factor, fibrinogen, platelet factor 4 or histidine-rich glycoprotein
• Active infection (sepsis or endocarditis)
• Preoperative intra-aortic balloon counterpulsation
• Thrombocytopenia
• Thrombocytosis
• Advanced age
• Plasma albumin concentration ≤ 35g/dl
• Relative hypovolaemia
Heparin resistance is also often encountered in acutely ill patients,
in patients with malignancy and during pregnancy or the post-partum
period.

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Adults
The usual dose in adults is 5,000 units injected into a vein. This
is followed by:
• 1,000-2,000 units/hour injected slowly into a vein
or
• 5,000-10,000 units 4 hourly injected all at once into a vein
Elderly
Lower doses may be used in the elderly
Small adults and children
Small adults and children will be given 50 units/kg body weight
injected into a vein followed by:
• 15-25 units/kg body weight/hour injected slowly into a vein
or
• 100 units/kg body weight 4 hourly injected all at once into a
vein
You will have blood tests every day to check the effects of your
heparin
To prevent a blood clot in the heart following a heart attack
Adults
The usual dose for adults is 12,500 units 12 hourly injected
under the skin for at least 10 days.
Elderly
A lower dose may be needed.
During heart and lung surgery (Adults)
Initially you will be given 300 units/kg. This will be changed
according to the results of your blood tests.
During kidney dialysis (Adults)
Initially you will be given 1,000 to 5,000 units. This will be
changed according to the results of your blood tests.
If you think you have been given too much heparin injection
Your doctor will decide which dose is best for you. Too much
heparin can cause bleeding. Slight bleeding can be stopped by
stopping your heparin treatment. However if you have more
severe bleeding you may need blood tests and an injection of a
medicine called protamine sulphate. If you think too much
medicine has been given to you contact your doctor or nurse.

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 national
reporting systems listed below.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, heparin injection may cause side effects in
some patients although not everybody gets them. These are
most likely to occur when treatment is first started. You should
inform your doctor or nurse immediately if you feel unwell.

What heparin injection contains
The active substance is heparin sodium.
Other ingredients include water for injections, hydrochloric acid
and sodium hydroxide.
Presentations available in the UK
1ml of solution of heparin injection 5,000 I.U./ml contains
5,000 international units of the active ingredient. It is available
in ampoules containing 5,000 I.U. in 1ml of solution and
25,000 I.U. in 5ml of solution. The registered pack size is
10 glass ampoules.
1ml of solution of heparin injection 25,000 I.U./ml contains
25,000 international units of the active ingredient. It is available
in 1ml ampoules containing 5,000 I.U. in 0.2ml of solution,
12,500 I.U. in 0.5ml of solution and 25,000 I.U. in 1ml of solution.
It is also available in 5ml ampoules containing 125,000 I.U.
in 5ml of solution. The registered pack sizes are 10, 15 and
50 glass ampoules.
Presentations available in Ireland
1ml of solution of heparin injection 25,000 I.U./ml contains
25,000 international units of the active ingredient. It is available
in 1ml ampoules containing 5,000 I.U. in 0.2ml of solution. The
registered pack size is 10 glass ampoules.
What heparin injection looks like and contents of the pack
Heparin injection is a colourless or straw-coloured liquid.
Other formats
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:

Important side effects to look out for:
• Severe allergic reactions
Heparin can cause a severe allergic reaction with difficulty
breathing, a blue tinge to the lips, swelling of the eyes and lips
or shock.
If you think you are having a severe allergic reaction
(see symptoms above) you must tell your doctor or nurse
immediately
• Bleeding and Bruising
Heparin injection can reduce the number of cells that help your
blood clot (thrombocytopenia) and so can cause bleeding and
bruising. This is most likely to occur within the first few days of
treatment but may occur later too. The risk of bleeding is
increased in the elderly (particularly elderly women).
Signs that you are bleeding more easily include:
• unusual bruising or purple spots on your skin
• unusual bleeding from your gums
• unusual nose bleeds
• blood in your urine (which may cause this to go dark)
• black, tarry-looking stools
• bleeding that will not stop from any operation site or other
injury
If you are concerned about unusual bleeding you must tell
your doctor or nurse immediately as you may need to stop
your heparin.
Other side effects include:
Common side effects (affects 1 to 10 users in 100):
• red lumps or red, itchy patches like eczema often develop
3-21 days after the start of heparin treatment, where
injections have been given under the skin
Rare side effects (affects 1 to 10 users in 10,000):
• raised levels of potassium in the blood, particularly in patients
with kidney failure or diabetes. If affected you may feel tired
and weak.
• allergic reactions including an itchy skin rash, eye irritation,
runny nose, wheezing, rapid breathing, a blue tinge to the
lips,fever, chills, swelling of the eyes and lips, and shock.
• irritation or sloughing of skin which may occur around the
injection site.
Side effects with unknown frequency:
• loss of hair (alopecia) if heparin sodium injection is given
over many months
• weakening of the bones (osteoporosis) if heparin sodium
injection is given over many months
• persistent erection of the penis (priapism)
• abnormal liver tests
• the amount of a hormone called aldosterone may be lower
than normal Your doctor can explain this more.
• high lipid levels on stopping heparin

4.5 Interaction with other medicinal products and other forms of
interaction
Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and
other NSAIDs, should be used with care. Increased risk of haemorrhage
with ketorolac (avoid concomitant use even with low-dose heparin).
Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with
oral anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase,
dipyridamole, dextran solutions, or any other drug which may interfere
with coagulation.
Cephalosporins: Some cephalosporins, e.g. cefaclor, cefixime and
ceftriaxone, can affect the coagulation process and may therefore
increase the risk of haemorrhage when used concurrently with heparin.
ACE inhibitors: Hyperkalaemia may occur with concomitant use.
Nitrates: Reduced activity of heparin has been reported with
simultaneous intravenous glyceryl trinitrate infusion.
Probenecid: May increase the anticoagulant effects of heparin.
Tobacco smoke: Nicotine may partially counteract the anticoagulant
effect of heparin. Increased heparin dosage may be required in smokers.
Interference with diagnostic tests may be associated with
pseudo-hypocalcaemia (in haemodialysis patients), artefactual increases
in total thyroxine and triiodothyronine, simulated metabolic acidosis and
inhibition of the chromogenic lysate assay for endotoxin. Heparin may
interfere with the determination of aminoglycosides by immunoassays.
4.6 Pregnancy and lactation
Heparin is not contraindicated in pregnancy. Heparin does not cross the
placenta or appear in breast milk. The decision to use heparin in
pregnancy should be taken after evaluation of the risk/benefit in any
particular circumstances.
Reduced bone density has been reported with prolonged heparin
treatment during pregnancy.
Haemorrhage may be a problem during pregnancy or after delivery.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Haemorrhage (see also Special Warnings and Precautions and
Overdosage Information).
Adrenal insufficiency secondary to adrenal haemorrhage has been
associated with heparin (rarely).
Thrombocytopenia has been observed occasionally (see also Special
Precautions and Warnings). Two types of heparin-induced thrombocytopenia
have been defined. Type I is frequent, mild (usually >50 x 109/L) and
transient, occurring within 1-5 days of heparin administration. Type II is
less frequent but often associated with severe thrombocytopenia (usually
<50 x 109/L). It is immune-mediated and occurs after a week or more
(earlier in patients previously exposed to heparin). It is associated with
the production of a platelet-aggregating antibody and thromboembolic
complications which may precede the onset of thrombocytopenia.
Heparin should be discontinued immediately.
There is some evidence that prolonged dosing with heparin (ie. over
many months) may cause alopecia and osteoporosis. Significant
bone demineralisation has been reported in women taking more than
10,000 I.U. per day of heparin for at least 6 months.
Heparin products can cause hypoaldosteronism which may result in an
increase in plasma potassium. Rarely, clinically significant hyperkalemia
may occur particularly in patients with chronic renal failure and diabetes
mellitus (see Warnings and Precautions).
Hypersensitivity reactions to heparin are rare. They include urticaria,
conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of
oppression, fever, chills, angioneurotic oedema and anaphylactic shock.
Local irritation and skin necrosis may occur but are rare. Erythematous
nodules, or infiltrated and sometimes eczema-like plaques, at the site of
subcutaneous injections are common, occurring 3-21 days after starting
heparin treatment.
Priapism has been reported. Increased serum transaminase values may
occur but usually resolve on discontinuation of heparin. Heparin
administration is associated with release of lipoprotein lipase into the
plasma; rebound hyperlipidaemia may follow heparin withdrawal.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Healthcare professionals
are asked to report any suspected adverse reactions via the national
reporting system:
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
4.9 Overdose
A potential hazard of heparin therapy is haemorrhage, but this is usually
due to overdosage and the risk is minimised by strict laboratory control.

United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:medsafety@hpra.ie
By reporting side effects you can help provide more information
on the safety of this medicine

5. HOW TO STORE HEPARIN INJECTION
Keep this medicine out of the reach and sight of children.
Your doctor or nurse will usually be responsible for storing and
preparing heparin injection before use and for checking that the
ampoules have not passed their expiry date stated on the carton
and the label. The medicine must not be used after the expiry
date which is stated on the carton and the label. The expiry date
refers to the last day of the month.
Heparin injection should not be given if it shows signs of
deterioration such as discolouration.
Do not store above 25°C. Store in the original packaging in
order to protect the product from light.
After opening, heparin ampoules must be used immediately. Any
portion of the contents not used at once should be discarded.
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.

Product Name
Heparin sodium 5,000 I.U./ml
solution for injection or
concentrate for solution for infusion
Heparin sodium 25,000 I.U./ml
solution for injection or
concentrate for solution for infusion

Reference Number
29831/0107
29831/0106

This is a service provided by the Royal National Institute of
Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
This leaflet was last revised in 09/2015

104826/6

Slight haemorrhage can usually be treated by withdrawing the drug.
If bleeding is more severe, clotting time and platelet count should be
determined. Prolonged clotting time will indicate the presence of an
excessive anticoagulant effect requiring neutralisation by intravenous
protamine sulphate, at a dosage of 1 mg for every 100 I.U. of heparin to
be neutralised. The bolus dose of protamine sulphate should be given
slowly over about 10 minutes and not exceed 50 mg. If more than
15 minutes have elapsed since the injection of heparin, lower doses of
protamine will be necessary.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Heparin is an anticoagulant and acts by inhibiting thrombin and by
potentiating the naturally occurring inhibitors of activated Factor X (Xa).
5.2 Pharmacokinetic properties
As heparin is not absorbed from the gastrointestinal tract and sublingual
sites it is administered by injection. After injection heparin extensively
binds to plasma proteins.
Heparin is metabolised in the liver and the inactive metabolic products
are excreted in the urine.
The half life of heparin is dependent on the dose.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are
additional to those already included in other sections.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
Sodium hydroxide solution 3M
Hydrochloric acid 3M
6.2 Incompatibilities
Heparin is incompatible with many injectable preparations e.g. some
antibiotics, opioid analgesics and antihistamines.
The following drugs are incompatible with heparin;
Alteplase, amikacin sulphate, amiodarone hydrochloride, ampicillin
sodium, aprotinin, benzylpenicillin potassium or sodium, cefalotin sodium,
chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium
besilate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam,
doxorubicin hydrochloride, droperidol, erythromycin lactobionate,
gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone
sodium succinate, kanamycin sulphate, labetolol hydrochloride, meticillin
sodium, methotrimeprazine, netilmicin sulphate, nicardipine
hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride,
polymyxin B sulphate, promethazine hydrochloride, streptomycin
sulphate, tobramycin sulphate, triflupromazine hydrochloride,
vancomycin hydrochloride and vinblastine sulphate.
Dobutamine hydrochloride and heparin should not be mixed or infused
through the same intravenous line, as this causes precipitation.
Heparin and reteplase are incompatible when combined in solution.
If reteplase and heparin are to be given through the same line this,
together with any Y-lines, must be thoroughly flushed with a 0.9% saline
or a 5% glucose solution prior to and following the reteplase injection.
6.3 Shelf life
Unopened –36 months
From a microbiological point of view, unless the method of opening
precludes the risk of microbial contamination, the product should be used
immediately. If not used immediately, in-use storage times and
conditions are the responsibility of the user.
6.4 Special precautions for storage
Do not store above 25°C
Store in the original package
6.5 Nature and contents of container
Neutral glass ampoules (Type I Ph Eur) of 1ml or 2ml capacity containing
0.2ml, 0.5ml and 1ml of solution and 5ml ampoules containing 5ml
of solution. Cartons contain 10, 15 or 50 ampoules. (UK only)
Neutral glass ampoules (Type I Ph Eur) of 1ml or 2ml capacity containing
0.2ml of solution. Cartons contain 10 ampoules. (Ireland only)
6.6 Special precautions for disposal
Not applicable
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd , Ash Road North. Wrexham, LL13 9UF, UK.
8. MARKETING AUTHORISATION NUMBER(S)
Heparin sodium injection 5,000 I.U./ml - PL 29831/0107
Heparin sodium injection 25,000 I.U./ml - PL 29831/0106, PA 1339/9/5
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:
Heparin sodium injection 5,000 I.U./ml
- 16 October 2007 (UK)
Heparin sodium injection 25,000 I.U./ml
-7 September 2007 (UK)
- 16 November 2007(Ireland)
10. DATE OF REVISION OF THE TEXT September 2015

104826/6

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Heparin Sodium PF leaflet

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Item Code

104826/6

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Date

22/12/2015

Artwork No.

622269

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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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