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

Active substance(s): HEPARIN CALCIUM

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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.
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)
· Preoperative intra-aortic balloon counterpulsation
· Thrombocytopenia

14/09/2015
Date

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Heparin Calcium Pres 25000U/ML Amp

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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

artwork.leicester@multipkg.com

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
• 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.

Wockhardt UK Limited

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.

Customer

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

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.

Measure bar should be 150mm at 100% scale

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.

· 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 immunemediated 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

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

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 , 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
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
September 2015

100036/10

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Date

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594495

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English
Language

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Min. Point Size

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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.

460mm x 148mm
Size

100036/10
Item Code

W-LFT003

Heparin Calcium Pres 25000U/ML Amp
Description

Pharma
Code

266

Text free area (non-printing)

Keyline (non-printing)

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Colours Used
Wockhardt UK Limited

Profile

Clearly mark any amendments on one proof and return to MPS

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.
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:
Product Name
Reference Number
Heparin calcium 25,000 I.U./ml solution
29831/0104
for injection or concentrate for solution
for infusion

Customer

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.

artwork.leicester@multipkg.com

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
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.’

Measure bar should be 150mm at 100% scale

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.

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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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