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MONOPARIN 25 000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): HEPARIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOPARIN 5,000 I.U./ml solution for injection or concentrate for solution for infusion
MONOPARIN 25,000 I.U./ml solution for injection or concentrate for solution for infusion
Preservative Free
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
The name of your medicine is either Monoparin 5,000 I.U./ml, or Monoparin 25,000 I.U./ml solution for
injection or concentrate for solution for infusion. In the rest of this leaflet 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 anti-coagulants. 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.
2. BEFORE YOU ARE GIVEN HEPARIN INJECTION
Heparin injection should not be given if you:
• are allergic to heparin or any of the other ingredients in your medicine, (see ‘What heparin injection
contains’ section 6)
• drink large amounts of alcohol
• are currently bleeding from anywhere in the body, (apart from your normal periods which do not stop
you being given heparin injection)
• have haemophilia (a genetic disorder which may cause you to bleed excessively) or any other
bleeding problem
• have or have ever had thrombocytopenia (a serious blood disorder which prevents blood from
clotting properly)
• bruise easily (fragile capillaries) or have lots of purple spots that look like bruises (purpura)
• have very high blood pressure
• are suffering from tuberculosis (TB)
• have had severe skin problems resulting from previous heparin treatment
• are about to have surgery of the brain, spine or eye, a lumbar puncture or local anaesthetic nerve
block, or some other procedure where bleeding could be a problem
• have recently had an operation
• suffer from severe liver problems which can lead to bleeding into the oesophagus (gullet)
• have bleeding into the brain.
Speak to your doctor before heparin injection is given if you:

• are over 60 years of age
• have any condition which makes you likely to bleed more easily (for example a stomach ulcer, hiatus
hernia, inflammation of the heart, problems in the back of your eye, haemorrhoids (piles), a stroke,
cancer or threatened miscarriage). If you are unsure, ask your doctor or nurse.
• suffer from diabetes
• suffer from excess acid or high levels of potassium in your blood or are taking a medicine that may
increase the potassium level in your blood (e.g. amiloride, triamterene, eplerenone or spironolactone).
If any of these apply you may need to have a blood test before the start of your heparin treatment. If
you are unsure, ask your doctor or nurse
• have kidney or liver disease. Your doctor may decide that a lower dose is necessary
• suffer from allergies or have previously had an allergic reaction to low molecular weight (LMW)
heparin. A small test dose of heparin sodium injection may be given first.
Your doctor will check your blood if you receive treatment for longer than five days and may do other
blood tests if you have major surgery.
Your doctor will take particular care if:
• you have an epidural or an anaesthetic given into the spine.
Taking other medicines
It is very important that you inform your doctor if you are taking, 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)
• medicines which may interfere with the proper clotting of the blood (e.g. dipyridamole, epoprostenol,
clopidogrel or streptokinase)
• cephalosporins, used to treat infections
• medicines called ACE inhibitors used for high blood pressure and heart failure (e.g. captopril,
enalapril, lisinopril or ramapril)
• medicines that may increase the potassium level in your blood (e.g. amiloride, triamterene,
eplerenone or spironolactone)
• glyceryl trinitrate given into a vein (for coronary heart disease)
• aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin or tobramycin)
• probenecid, used in the treatment of gout
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.
You may need to have blood tests if you are receiving higher doses of heparin or if you are pregnant
to check on the effects of your heparin treatment.
You may require a lower dose if you have kidney or liver disease.
To PREVENT blood clots in leg veins (deep vein thrombosis) and blood clots in the lung
(pulmonary embolism)
Adults
The usual dose of heparin injection in adults is 5,000 units injected under the skin 2 hours before your
operation, followed by 5,000 units injected under the skin every 8-12 hours, for 7-10 days or until you
are fully able to move about.
Pregnancy
During pregnancy the dosage is 5,000-10,000 units injected under the skin every 12 hours. The dose
may be adjusted according to your blood tests.
Elderly
Lower doses may be used in the elderly.
You may need to have blood tests if you are elderly, to check on the effects of your heparin treatment.
Children
No specific doses are recommended.
To TREAT blood clots in leg veins (deep vein thrombosis) and blood clots in the lung
(pulmonary embolism)
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
• 10,000-20,000 units 12 hourly injected under the skin
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 50units/kg body weight injected into a vein followed by:
• 15-25 units/kg body weight/hour injected slowly into a vein
or
• 250 units/kg body weight 12 hourly injected under the skin
or
• 100 units/kg body weight 4 hourly injected all at once into a vein
To TREAT chest pains (unstable angina pectoris) and severe blood clots in the arteries (acute
peripheral arterial oclcusion)
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 boyd 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 body weight. This will be changed according to the results of
your blood tests.
During kidney dialysis (Adults)
Initially you will be given 1,000 - 5,000 units per hour. 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.
4. POSSIBLE SIDE EFFECTS
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.
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 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
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.
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 vials 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.

6. FURTHER INFOMATION
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
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Please be ready to give the following information:
Product Name
Monoparin 5,000 I.U./ml solution for injection or
concentrate for solution for infusion
Monoparin 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

1. NAME OF THE MEDICINAL PRODUCT
Monoparin 25,000 I.U./ml Solution for injection or concentrate for solution for infusion
(UK and Ireland)
Monoparin 5,000 I.U./ml Solution for injection or concentrate for solution for infusion (UK only)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Monoparin 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)
Monoparin 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:
followed by:

5,000 units subcutaneously
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 arteria l occlusion:
Adults:
Loading dose:
5,000 units intravenously
Maintenance:
1,000-2,000 units/hour by intravenous infusion, or 5,000-10,000 units 4hourly 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:
Haemodialysis
and haemofiltration:
Maintenance:

Initially 300 units/kg intravenously, adjusted thereafter to maintain the
activated clotting time (ACT) in the range 400-500 seconds.
Initially 1,000-5,000 units,
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,
oestrogen 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.
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 lowdose 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. 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)
Monoparin injection 5,000 I.U./ml - PL 29831/0107
Monoparin 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:

Monoparin injection 5,000 I.U./ml - 16 October 2007 (UK)
Monoparin injection 25,000 I.U./ml -7 September 2007 (UK)
- 16 November 2007 (Ireland)
10. DATE OF REVISION OF THE TEXT
September 2015

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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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