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

Active substance: HEPARIN CALCIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPARIN CALCIUM 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 heparin calcium 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 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.
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 does 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

1.NAME OF THE MEDICINAL PRODUCT
Heparin calcium 25,000 I.U./ml Solution for injection or concentrate for
solution for infusion.
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin calcium 25,000 I.U./ml (5,000 I.U. in 0.2ml)
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.

• suffer from allergies or have previously had an allergic reaction
to low molecular weight (LMW) heparin. A small test dose of
heparin calcium 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 may 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.

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, 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
· Active infection (sepsis or endocarditis)

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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 occlusion)
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 per 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.

· 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 interactions
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).

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
injection is given over many
months
• weakening of the bones (osteoporosis) if heparin 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
If any of the side effects gets serious or you notice any side effects
not listed in this leaflet , please tell your doctor, or nurse.
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.
6. FURTHER INFORMATION
What heparin injection contains
The active substance is heparin calcium.
1ml of solution of heparin calcium 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.
Other ingredients include water for injections, hydrochloric acid and
calcium hydroxide.
What heparin injection looks like and contents of the pack
Heparin injection is a colourless or straw-coloured liquid.
Each carton contains 10 ampoules.
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Heparin calcium 25,000 I.U./ml
solution for injection or concentrate for solution for infusion

29831/0104

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 revised in 07/2013.

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
6.1List of excipients
Water for injections , Calcium 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
Heparin calcium injection should not be stored above 25°C. Store in the original package
6.5 Nature and contents of container
Neutral glass ampoules (Type I Ph Eur) of 1ml capacity containing 0.2ml of solution.
Cartons contain 10 ampoules.
6.6 Special precautions for disposal
Not applicable

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.

7.MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd , Ash Road North , Wrexham , LL13 9UF, UK.
8. MARKETING AUTHORISATION NUMBER(S)
Heparin calcium 25,000 I.U./ml - PL 29831/0104
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation:
Heparin calcium 25,000 I.U./ml – 12 September 2007
10. DATE OF REVISION OF THE TEXT
July 2013.

100036/9

Measure bar should be 150mm at 100% scale
Customer

Wockhardt UK Limited

Colours Used

Description

Heparin calcium 25,000 I.U./ml leaflet

Process Black

Item Code

100036-9

Profile

6.5pt

Market

UK

Language

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

460x148

Min. Point Size

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Artworker to fill in

Size

English

Proof By

elkie.bramall

Proof No.

1

Date

15/07/2013

Keylines

Artwork No.

454794

Pharma
Code

214

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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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