100 IU / ml injection solution
heparin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Heparin LEO is and what it is used for
2. What you need to know before you use Heparin LEO
3. How to use Heparin LEO
4. Possible side effects
5. How to store Heparin LEO
6. Contents of the packaging and other information

1. What Heparin LEO is and what it is used for

Heparin prevents the formation of blood clots by reducing the blood’s ability to coagulate. This strength of Heparin is used when rinsing venous cannula after drip.

2. What you need to know before using Heparin LEO

Do not use Heparin LEO

  • If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
  • Ongoing or previous immunologically mediated heparin-induced thrombocytopenia (type II) (decreased platelet count ).
  • Heavy active bleeding or at risk of heavy bleeding.
  • Bacterial infection of the heart ( septic endocarditis ).
  • If you are going to receive local anesthesia .
  • If you are being treated with heparin , do not have an epidural catheter ( catheter for spinal anesthesia) inserted. Removal or modification of an epidural catheter should only be done if your doctor considers that the benefits of removing the epidural catheter outweigh the risks.

Heparin LEO contains the preservative benzyl alcohol. This must not be given to newborns or premature infants (see “Heparin LEO contains methyl and propyl parahydroxybenzoate, benzyl alcohol and sodium”).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Heparin LEO.

Special care must be taken if you:

  • has an increased risk of bleeding.
  • taking drugs that affect platelet function or the coagulation system. The combination with Heparin LEO should be avoided or closely monitored.
  • undergo spinal cord tests or spinal anesthesia. In very rare cases, concomitant prophylactic use of Heparin LEO may result in prolonged or permanent paralysis.

For spinal cord tests or other spinal anesthesia, prophylactic treatment with Heparin LEO should be discontinued 4-6 hours before the procedure. Heparin LEO should not be given until at least 1 hour after the procedure. If Heparin LEO is given as an intravenous treatment, it should be stopped 4-6 hours before the procedure, if the treatment is given under the skin ( subcutaneously ) it should be stopped 8-12 hours before the procedure. Heparin LEO can be given again no earlier than 1 hour after the procedure.

If you receive Heparin LEO in connection with spinal anesthesia, you must pay close attention to any signs and symptoms of neurological deterioration such as back pain, sensory or motor deficits (numbness and weakness in the legs), or if the bowel and bladder do not function normally. You should immediately tell a nurse or a doctor if you experience any of these symptoms.

Heparin LEO should not be given to muscles. Due to the risk of bleeding under the skin, other medicines given to a muscle should not be given at the same time.

Heparin treatment can cause elevated levels of potassium in the blood. The risk increases if you have diabetes, impaired kidney function, previous disturbance of the acid-base balance, elevated potassium levels in the blood before treatment, concomitant treatment with drugs that raise the potassium level in the blood, or if you are treated with Heparin for a long time. If you have any of these conditions, your blood potassium levels should be measured before and during treatment.

Other medicines and Heparin LEO

Tell your doctor or pharmacist if you have recently taken or might take any other medicines.

The treatment effect may be affected if this medicine is taken at the same time as other medicines.

Some medicines that affect blood and coagulation may increase the risk of bleeding during Heparin LEO treatment, e.g. acetylsalicylic acid and other painkillers and anti-inflammatory drugs called NSAIDs, certain antidepressants called selective serotonin reuptake inhibitors ( SSRIs ), and drugs that dissolve or prevent the formation of blood clots, which; thrombolytic agents, vitamin -K- antagonists, activated protein C, and direct thrombin inhibitors. If your doctor thinks that Heparin LEO should be given at the same time as its medicine, you should be closely monitored.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Heparin treatment of pregnant women requires specialist care.

Heparin LEO can be used during pregnancy if necessary

Heparin is not excreted in human milk and can be used during breastfeeding.

Driving and using machines

Heparin LEO does not affect your ability to drive. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Heparin LEO contains methyl and propyl parahydroxybenzoate, benzyl alcohol and sodium

Methyl (E218) and propyl parahydroxybenzoate (E216):

May cause an allergic reaction (possibly delayed) and exceptionally spasm of the trachea.

Benzyl alcohol:

This medicine contains 10 mg of benzyl alcohol per ml.

Benzyl alcohol can cause allergic reactions.

Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing in young children.

Do not give this medicine to newborns (up to 4 weeks of age) or premature babies. Do not use this medicine for more than 1 week in children (younger than 3 years) unless your doctor or pharmacist has recommended it.

If you have impaired liver function or kidney function, consult your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).

Sodium:

This medicine contains 36 mg sodium (the main ingredient in table salt/table salt) per 10 ml vial. This corresponds to 1.8% of the highest recommended daily intake of sodium for adults.

3. How to use Heparin LEO

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Heparin 100 IU / ml is used for rinsing venous cannula after drip. This is normally done by hospital staff.

If you use more Heparin LEO than you should 

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Bleeding is the major complication of high dose heparin . If the bleeding is small, it is enough to stop the treatment to stop it. In case of severe bleeding, you can get protamine sulphate to stop the bleeding.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Common (affects more than 1 user in 100) BleedingBruisesElevated levels of liver enzymeReddening of the skin
Uncommon (affects less than 1 user in 100) Decreased platelet count ( thrombocytopenia )Severe allergic reactionHeparin-induced thrombocytopenia (type II)HypersensitivityToo high a level of potassium in the bloodLocal tissue deathDifferent types of rash, hivesItchingOsteoporosis (for long-term treatment)Persistent, painful erectionPain at the injection siteAPTT (method of measuring blood coagulation capacity ) gives results that are out of scale

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Heparin LEO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date refers to the last day of that month.

No special storage instructions. Opened packaging is stable for 28 days at a maximum of 30 ºC.

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. Contents of the packaging and other information

Content declaration

  • The active substance is heparin sodium, 100 IU / ml
  • The other ingredients are benzyl alcohol, methyl parahydroxybenzoate E218, propyl parahydroxybenzoate E216, sodium citrate, sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

Heparin LEO contains very small amounts of sodium chloride, ie is almost “sodium-free”.

What the medicine looks like and contents of the pack

Glass vials 10 x 10 ml.

Marketing Authorization Holder and Manufacturer

LEO Pharma AB

Box 404

201 24 Malmö

Muhammad Nadeem

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