Patient leaflet - Heparin Sodium 5 000 I.U./ml solution for injection/infusion
1. What Heparin sodium is and what it is used for
The name of this medicine is Heparin sodium 5,000 I.U. / ml solution for injection/infusion (referred to as ‘Heparin sodium’ in this leaflet). Heparin sodium belongs to a group of medicines called anticoagulants. This medicine prevents blood clotting.
Heparin sodium is 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. What you need to know before you are given Heparin sodium
You must not be given Heparin sodium if you:
are allergic to heparin or any of the other
ingredients of this medicine (listed in section 6)
- bleed or bruise easily
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.
drink large amounts of alcohol
are currently bleeding from anywhere in
the body, (apart from your normal periods which do not stop you being given heparin injection)
have haemophilia (a genetic disorder
which may cause you to bleed excessively) or any other bleeding problem
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)
Warnings and precautions
Talk to your doctor or nurse before receiving Heparin sodium. Particularly careful medical supervision is required if you:
- are over 60 years of age
have any condition which makes you likely
to bleed more easily. If you are unsure, ask your doctor or nurse
- are diabetic
have high levels of potassium in your blood
or are taking a medicine that may increase the potassium level in your blood
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 heparin.
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.
Other medicines and Heparin sodium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 (for example, diclofenac or ibuprofen)
Medicines which may interfere with the
proper clotting of the blood (for example, dipyridamole, epoprostenol, clopidogrel or streptokinase)
- Medicines that may increase the potassium level in your blood
- Glyceryl trinitrate (for heart disease) 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 Heparin sodium is given.Tobacco smoke can also interfere with the working of heparin injection. You should inform your doctor if you smoke.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.
Pregnancy
If you are being given heparin injection, bleeding may be a problem during pregnancy or after delivery. Particular caution is required at the time of delivery and heparin should be stopped at the onset of labour, due to the risk of bleeding. Your bones may get thinner if you receive heparin for a long time during pregnancy.
If you are pregnant and are going to have an epidural anaesthetic, you should stop having your medicine. Ask your doctor for advice.
Breast-feeding
Heparin is not excreted into breast milk.
Driving and using machines
Heparin sodium 5,000 I.U. / mL has not been reported to affect ability to drive or operate machines.
Heparin contains sodium
1 mL ampoule: This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially “sodium-free” (maximum about 3.76 mg sodium per 1 mL ampoule).
5 mL ampoule: This medicine contains less than 1 mmol sodium (23 mg) per 5 mL, that is to say essentially “sodium-free” (maximum about 18.80 mg sodium per 5 mL ampoule).
This should be taken into consideration in patients on a controlled sodium diet.
3. How Heparin sodium is 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. Your doctor will decide which dose is best for you.
The amount injected all at once into a vein should not be more than 15 mL.
You may need to have blood tests if you are receiving higher doses of heparin 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.
- During pregnancy: 5,000 – 10,000 units every 12 hours under the skin.
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 for children.
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.
Adolescents and children
Adolescents and children will be given 50 units / kg bodyweight injected into a vein followed by:
- 15 – 25 units / kg bodyweight/hour injected slowly into a vein or
- 250 units / kg bodyweight 12 hourly injected under the skin or
- 100 units / kg bodyweight 4 hourly injected all at once into a vein
ARIAL 9 pt - 160*840 mm
The following information is intended for healthcare professionals only:
Posology and Method of administration
Method of administration
By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride or by intermittent intravenous injection, or by subcutaneous injection.
The intravenous injection volume of heparin injection should not exceed 15 mL. As the effects of heparin are short-lived, administration by intravenous infusion or subcutaneous injection is preferable to intermittent intravenous injections.
Posology
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.
Paediatric population: 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 adolescents:
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 adolescents:
Loading dose: 50 units / kg
intravenously
Maintenance: 15 – 25
units / kg / hour by intravenous infusion, or 100 units / kg 4-hourly by
intravenous injection. 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 maybe used in the elderly.
Adolescents and children
Adolescents and children will be given 50 units / kg body weight injected into a vein followed by:
15 – 25 units / kg bodyweight / hour injected slowly into a vein or
100 units / kg body weight 4 hourly injected all at once into a vein
You will have blood tests every day to check the effects of your heparin.
To prevent a blood clot in the heart following a heart attack:
Adults
The usual dose for adults is 12,500 units 12 hourly injected under the skin for at least 10 days.
Elderly
A lower dose may be needed.
During Heart and Lung Surgery (Adults)
Initially you will be given 300 units / kg body weight. This will be changed according to the results of your blood tests.
During kidney dialysis (Adults)
Initially you will be given 1,000 – 5,000 units. This will be changed according to the results of your blood tests.
If you are given too much Heparin sodium
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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Important side effects to look out for
(frequency unknown):
Severe allergic reactions
Heparin can cause a severe allergic reaction with wheezing, difficulty breathing, a blue tinge to the lips, fever, chills, swelling of the eyes and lips and shock.
If you think you are having a severe allergic reaction you must stop receiving heparin and tell your doctor or nurse immediately.
Bleeding and Bruising
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. 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).
If you are concerned about unusual bleeding you must tell your doctor or nurse immediately as you may need to stop your heparin treatment.
Other side effects (frequency unknown) include:
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
sloughing of skin may occur around the
injection site
- persistent erection of the penis
abnormal results for blood tests that report
on how the liver is working
high level of blood fats after stopping
heparin
high or low blood potassium. If affected
you may feel tired and weak.
If heparin injection is given over many months then the following may occur:
- loss of hair
thinning of the bones (osteoporosis)
Reporting of side effects
If you get any side effects, talk to your doctor or, 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 at: Website: www. mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Heparin sodium
Keep this medicine out of the sight and reach of children.
Your doctor or nurse will usually be responsible for storing and preparing injection before use and for checking that the ampoules have not passed their expiry date stated on the carton and the label.
This 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 that month.
This medicinal product does not require any special storage conditions.
Heparin sodium should not be given if it shows signs of deterioration such as discolouration.
Shelf-life after first opening and dilution: Chemical and physical in-use stability after dilution in glucose 5% and in 0.9% sodium chloride solution has been demonstrated for 48 hours below 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
The active substance is heparin sodium.
Each ampoule with 1 mL Heparin sodium contains 5,000 I.U. of heparin sodium. Each ampoule with 5 mL Heparin sodium contains 25,000 I.U. of heparin sodium.
- The other ingredients are sodium hydroxide or hydrochloric acid and water for injections. Each ampoule with 1 mL Heparin sodium contains 3.76 mg (0.164 mmol) of sodium. Each ampoule with 5 mL Heparin sodium contains 18.80 mg (0.817 mmol) of sodium.
What Heparin sodium looks like and contents of the pack
Heparin sodium 5,000 I.U. / mL Solution for injection / infusion is packed in clear glass ampoules. Packs of 5, 10, 50 ampoules of 1 mL or 5 mL solution for injection / infusion are available.
Heparin sodium 5,000 I.U. / mL Solution for injection / infusion is packed in plastic ampoules, overwrapped with or without a protective pouch. Packs of 5, 10 and 50 ampoules of 5 mL solution for injection / infusion are available.
Not all packs sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DEMO PHARMA UK LIMITED
2nd Floor Connect 38,
1 Dover Place, Ashford,
Kent TN23 1FB, England
Manufacturer
DEMO S.A., PHARMACEUTICAL INDUSTRY, 21st km National Road Athens-Lamia, GR-14568 Krioneri, Attiki, Greece
T: +30 210 8161802, F: +30 210 8161587.
This leaflet was last revised in 06/2025.
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.
Special precautions for disposal and other handling
For single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section “Special precautions for storage”.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Shelf-life after first opening and dilution Chemical and physical in-use stability after dilution in glucose 5% and in 0.9% sodium chloride solution has been demonstrated for 48 hours below 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Overdose
Bleeding is the main sign of overdose with heparin. As heparin is eliminated quickly, a discontinuation of treatment is sufficient in case of minor haemorrhages. In case of severe haemorrhages heparin may be neutralised with protamine sulphate injected slowly intravenously. One mg of protamine sulphate neutralises approximately 100 IU of heparin. Nevertheless, the required protamine sulphate dose varies according to the time of heparin administration and the dose administered.
It is important to avoid overdosage of protamine sulphate because protamine itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50 mg. Intravenous injection of protamine may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.