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MULTIPARIN 1000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): HEPARIN

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Heparin injection must not be given to premature or
newborn babies.
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 sodium 1,000 I.U./ml solution for injection or concentrate for
solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 1,000 I.U./ml (Heparin sodium 5,000 I.U./ml in 5ml)
For a full list of excipients, see section 6.1.

The methyl parahydroxybenzoate in heparin injection may
cause allergic reactions (possibly delayed) and exceptionally
bronchospasm
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).
The amount injected all at once into a vein should not be
greater than 15ml.
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.
Heparin injection must not be given to premature or
newborn babies.
You may require a lower dose if you have kidney or liver disease.
To TREAT blood clots in leg veins (deep vein thrombosis),
blood clots in the lung (pulmonary embolism), chest
pains (unstable angina pectoris) and severe blood clots
in the arteries (acute peripheral arterial occlusion).

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.

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.

4.4 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.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of deep vein thrombosis, pulmonary embolism, unstable angina
pectoris and acute peripheral arterial occlusion.

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).

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.
The intravenous injection volume of heparin injection should not exceed 15ml.
As the effects of heparin are short-lived, administration by intravenous
infusion is preferable to intermittent intravenous injections.

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.
Heparin injection contains benzyl alcohol (10mg/ml) and methyl
parahydroxybenzoate as preservatives. Caution should be used if
prescribing heparin injection to susceptible patients. Benzyl alcohol may
cause toxic reactions and anaphylactoid reactions in infants and children
up to three years old. Methyl parahydroxybenzoate may cause allergic
reactions (possibly delayed) and, exceptionally, bronchospasm.

Recommended dosage
Treatment of deep vein thrombosis, pulmonary embolism, unstable angina
pectoris, acute peripheral arterial occlusion:

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.

Adults:
Loading Dose:

Caution is recommended in spinal or epidural anaesthesia (risk of spinal
haematoma).

Maintenance:

5,000 units intravenously (10,000 units
may be required in severe pulmonary
embolism)
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:
Maintenance:

50 units/kg intravenously
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.
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
Known hypersensitivity to heparin or any of the other ingredients.
Must not be given to premature babies or neonates (contains benzyl
alcohol).
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.

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 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.

2

17/09/2015

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

Important information about the ingredients benzyl
alcohol and methyl parahydroxybenzoate
The benzyl alcohol in heparin injection may cause toxic
reactions and allergic reactions in infants and children up to
three years old.

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.

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.

Clearly mark any amendments on one proof and return to MPS

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 and ‘Important information about some of the
ingredients of heparin injection’ below)
• drink large amounts of alcohol
• are currently bleeding from anywhere in the body,
(apart from your normal period 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.

Tobacco smoke can also interfere with the working of heparin
injection. You should inform your doctor if you smoke.

artwork.leicester@multipkg.com

It is also used during heart and lung operations and during
kidney dialysis.

If you need one of the above medicines your doctor may
decide to alter the dose of heparin injection or the other
medication. If you have any doubts about whether this
medicine should be administered then discuss things more
fully with your doctor or nurse before it is given.

Item Code

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:
• 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)

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

Heparin Sodium pres 1000U/ML Vial

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

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.

Wockhardt UK Limited

The name of your medicine is heparin sodium 1,000 I.U./ml
solution for injection or concentrate for solution for infusion.
In the rest of this leaflet it is called heparin injection.

Your doctor will take particular care if:
• the patient is an infant or child under three years old
• you have an epidural or an anaesthetic given into the spine.

Description

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.

Customer

HEPARIN SODIUM 1,000 I.U./ml solution for
injection or concentrate for solution for infusion
Contains Preservative

• 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.

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR THE USER

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:
Rare side effects (affects 1 to 10 users in 10.000):
• raised levels of potassium in the blood, particularly in
patients with kidney failure or diabetes. If affected you
may feel tired and weak.
• allergic reactions including an itchy skin rash,
eye irritation, runny nose, wheezing, rapid breathing,
a blue tinge to the lips, fever, chills, swelling of the eyes
and lips, and shock.
• irritation or sloughing of skin which may occur around the
injection site.

Please be ready to give the following information:
Product Name
Reference Number
Heparin sodium 1,000 I.U./ml
29831/0109
solution for injection or
concentrate for solution for infusion
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.

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

100038/9

ACE inhibitors: Hyperkalaemia may occur with concomitant use.
Nitrates: Reduced activity of heparin has been reported with
simultaneous intravenous glyceryl trinitrate infusion.

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.

This leaflet was last revised in 09/2015

5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Tobacco smoke: Nicotine may partially counteract the anticoagulant
Heparin is an anticoagulant and acts by inhibiting thrombin and by
effect of heparin. Increased heparin dosage may be required in smokers. potentiating the naturally occurring inhibitors of activated Factor X (Xa).
5.2 Pharmacokinetic properties
Interference with diagnostic tests may be associated with pseudo-hypoAs heparin is not absorbed from the gastrointestinal tract and sublingual
calcaemia (in haemodialysis patients), artefactual increases in total
sites it is administered by injection. After injection heparin extensively
thyroxine and triiodothyronine, simulated metabolic acidosis and inhibition binds to plasma proteins.
of the chromogenic lysate assay for endotoxin. Heparin may interfere
with the determination of aminoglycosides by immunoassays.
Heparin is metabolised in the liver and the inactive metabolic products are
excreted in the urine.
4.6 Pregnancy and lactation
Heparin is not contraindicated in pregnancy. Heparin does not cross the
The half life of heparin is dependent on the dose.
placenta or appear in breast milk. The decision to use heparin in
pregnancy should be taken after evaluation of the risk/benefit in any
5.3 Preclinical Safety Data
particular circumstances. Reduced bone density has been reported with
There are no pre-clinical data of relevance to the prescriber which are
prolonged heparin treatment during pregnancy.
additional to those already included in other sections.
Haemorrhage may be a problem during pregnancy or after delivery.
6. PHARMACEUTICAL PARTICULARS
4.7 Effects on ability to drive and use machines
6.1 List of excipients
None stated.
Benzyl alcohol
Methyl parahydroxybenzoate (E218)
4.8 Undesirable effects
Water for injections
Haemorrhage (see also Special Warnings and Precautions and
Sodium hydroxide solution
Overdosage Information).
Hydrochloric acid
Probenecid: May increase the anticoagulant effects of heparin.

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).

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.

Hypersensitivity reactions to heparin are rare. They include urticaria,
conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of
oppression, fever, chills, angioneurotic oedema and anaphylactic shock.
In some instances the precipitating agent will prove to be the preservative 6.3 Shelf life
rather than the heparin itself.
36 months
Local irritation and skin necrosis may occur but are rare.
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

Chemical and physical in use stability has been demonstrated for 28 days
at 25°C.
From a microbiological point of view, once opened, the product may be
stored for a maximum of 28 days at 25°C. Other 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
5ml multidose neutral glass (Type 1, Ph Eur) vial. Carton containing
10 vials.
6.6 Special precautions for disposal
Each multidose vial should be restricted to use in a single patient.
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd, Ash Road North, Wrexham , LL13 9UF, UK.
8. MARKETING AUTHORISATION NUMBER(S)
PL 29831/0109
PA 1339/9/6
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Date of first authorisation:
15 October 2007 (UK)
16 November 2007 (Ireland)
10. DATE OF REVISION OF THE TEXT
September 2015

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English

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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.

7pt

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Size

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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.
4. POSSIBLE SIDE EFFECTS
The expiry date refers to the last day of the month.
Like all medicines, heparin injection may cause side effects in Heparin injection should not be given if it shows signs of
some patients, although not everybody gets them. These are deterioration such as discolouration.
most likely to occur when treatment is first started. You should Do not store above 25°C. Store in the original packaging in
inform your doctor or nurse immediately if you feel unwell.
order to protect the product from light.
After opening, heparin vials may be kept for 28 days at
Important side effects to look out for:
25°C, after which they should be discarded.
• Severe allergic reactions
Heparin can cause a severe allergic reaction with wheezing, Medicines should not be disposed of via wastewater or
difficulty breathing, a blue tinge to the lips, fever, chills,
household waste. Ask your pharmacist how to dispose of
swelling of the eyes and lips and shock.
medicines no longer required. These measures will help to
protect the environment.
Allergic reactions may be due to the ingredients in your
heparin rather than the heparin itself. This occurs
6. FURTHER INFORMATION
particularly in infants or children up to three years old.
What heparin injection contains
The active substance is heparin sodium.
If you think you are having a severe allergic reaction
(see symptoms above) you must tell your doctor or
1ml of solution of heparin sodium injection 1,000 I.U./ml
nurse immediately.
contains 1,000 international units of the active ingredient.
It is available in 5ml multidose vials containing 5,000 I.U. in
• Bleeding and Bruising
5ml of solution.
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 Other ingredients include benzyl alcohol (10mg/ml), methyl
days of treatment but may occur later too. The risk of bleeding parahydroxybenzoate (E218) (as preservatives), water for
injections, hydrochloric acid and sodium hydroxide.
is increased in the elderly (particularly elderly women).
What heparin injection looks like and contents of the pack
Signs that you are bleeding more easily include:
Heparin injection is a colourless or straw-coloured liquid.
• unusual bruising or purple spots on your skin
• unusual bleeding from your gums
Each carton contains 10 glass vials.
• unusual nose bleeds
• blood in your urine (which may cause this to go dark)
Other formats
• black, tarry-looking stools
listen to or request a copy of this leaflet in Braille, large
• bleeding that will not stop from any operation site or other To
print or audio please call, free of charge:
injury
0800 198 5000 (UK Only)

Item Code

By reporting side effects you can help provide more
information on the safety of this medicine.

Heparin Sodium pres 1000U/ML Vial

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.

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

Wockhardt UK Limited

During Kidney dialysis (Adults)
Initially you will be given 1,000-5,000 units. This will be
changed according to the results of your blood tests.

United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard

Description

During Heart and Lung Surgery (Adults)
Initially you will be given 300 units/kg. This will be changed
according to the results of your blood tests.

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.

Customer

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

• 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

Measure bar should be 150mm at 100% scale

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

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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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