This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use INNOHEP 4,500 IU Anti-Xa/0.45 mL Injectable Solution in Syringes

Introduction

Package Leaflet: Information for the User

innohep 4,500 IU anti-Xa/0.45 ml solution for injection in pre-filled syringes

(10,000 IU anti-Xa)

tinzaparin sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
In this leaflet, the term "innohep" refers to "innohep 4,500 IU anti-Xa/0.45 ml solution for injection in pre-filled syringes".

Contents of the pack

What is innohep and what it is used for
What you need to know before you use innohep
How to use innohep
Possible side effects
Storage of innohep
Contents of the pack and other information

1. What is innohep and what it is used for

innohep is a medicine that makes the blood more fluid by reducing the blood's natural ability to form clots.

innohep is used to

prevent the formation of blood clots in adults before and after surgery.

prevent the formation of blood clots in adults with a higher risk of blood clot formation, for example, due to an acute illness with limited mobility.

prevent the formation of blood clots in the blood in hemodialysis equipment in patients undergoing hemodialysis or hemofiltration. In hemodialysis, waste and fluids from the blood are removed by the machine and the dialysis filter that acts like an artificial kidney.

2. What you need to know before you use innohep

Do not use innohep:

if you are allergic to tinzaparin sodium or any of the other ingredients of this medicine (listed in section 6).
if you have or have had heparin-induced thrombocytopenia.
if you have a severe bleeding disorder (e.g., in the brain, spinal cord, eyes, or stomach).
if you have a severe infection of the heart (septic endocarditis).

Warnings and precautions

Consult your doctor or nurse before starting to use innohep:

if you are going to have a spinal or epidural anesthesia or a lumbar puncture.
if you know you have a tendency to bleed.
if you are being treated with other medicines by injection.
if you have a low platelet count in your blood.
if you have high levels of potassium in your blood (hyperkalemia).
if you have a prosthetic heart valve.
if you have kidney problems.

Children and adolescents

innohep is not indicated for use in children and adolescents.

Using innohep with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Some medicines may interact with the effect of innohep.

Tell your doctor if you are using any of the following medicines as you may bleed more easily:

Medicines for the treatment of inflammation and pain, especially non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid.
Medicines used to dissolve blood clots (thrombolytic agents)
Medicines that block the action of vitamin K (vitamin K antagonists)
Activated protein C
Direct inhibitors of factor Xa and IIa.

Pregnancy and breastfeeding

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 using this medicine.

innohep in pre-filled syringes can be used during all trimesters of pregnancy.

If epidural anesthesia is necessary, you must inform your doctor that you are using innohep.

Tell your doctor or nurse if you have a prosthetic heart valve.

Driving and using machines

innohep does not affect the ability to drive and use machines.

innohep contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per ml; this is essentially "sodium-free".

3. How to use innohep

Follow exactly the administration instructions of this medicine indicated by your doctor or nurse. If in doubt, consult your doctor or nurse again.

Your doctor may ask you to have routine blood tests to assess the effect of innohep.

To prevent the formation of blood clots in your veins

innohep must be injected under the skin (subcutaneous injection). The dose and duration of treatment will depend on the type of surgery or illness you have. Your doctor will indicate the appropriate dose for you and the duration of your treatment.

To prevent the formation of blood clots in the blood during hemodialysis or hemofiltration

innohep will be introduced into the circuits of the hemodialysis machine or administered intravenously. The dose will depend on the duration of dialysis.

Instructions on how to inject innohep:

Wash your hands carefully before injecting this medicine. Clean the skin around the injection site with an alcohol swab and let it dry without rubbing.

Hands holding an injection device with exposed needle and arrow indicating direction of insertion

Open the syringe container by lifting the colored cap all the way back and remove the syringe.

Inspect the contents of the syringe before use. If you notice turbidity or a precipitate in the medicine, do not use it and take another syringe. The medicine may have a yellowish color during storage, but it can be used as long as the solution is clear and the expiration date has not been exceeded. Each syringe can only be used once.

Hand holding a syringe with exposed needle while another hand guides the insertion into the skin

Fold the safety device downwards, separating it from the needle protector cap.

Two hands holding a syringe with exposed needle preparing for a subcutaneous or intramuscular injection

Remove the cap that protects the needle without twisting it. Do not pull the plunger back or remove the air bubble contained in the syringe. If the air bubble is not correctly positioned next to the plunger, gently tap the syringe until the air bubble is in place, next to the plunger.

Hand holding a syringe with needle inserted into the skin of the arm at an inclined angle showing the injection site

Take a skin fold, without pressing, between the thumb and index finger of one hand and with the other hand insert the needle vertically into the skin fold, i.e., at a right angle to the skin.

Schematic representation of injection areas on the arms and legs with multiple marked points and indicative lines

Slowly inject the necessary dose into the fatty tissue, for example, the skin of the abdominal area, the front of the thighs, the lower back, or the back of the arms. Wait a few seconds to allow the solution to spread before removing the needle and releasing the skin fold.

Clean the area with a swab if you have bled. Choose a different injection site for the next time (e.g., alternating between the left and right side of the abdomen).

Hand holding a syringe with needle inserted into the skin showing a circular motion and downward pressure

Hand holding a pre-filled pen with needle being inserted into the skin with a rotational movement indicated by a curved arrow

Fold the safety device back to its original position so that it is parallel to the needle. Then, with the safety device flat on a rigid surface, press down until the needle is locked in the device.

Hand holding an applicator device with needle inserted and arrow indicating direction of withdrawal

The used syringe, with the needle facing down, can be inserted into the syringe container or a container for sharp objects. In this way, the syringe is safe, and the container with the syringe or the container for sharp objects can be delivered to a hospital or pharmacist for destruction.

If you use more innohep than you should

If you are treated with more innohep than you need, bleeding may occur. Consult your doctor or nurse immediately if you do not feel well or think you have been given too high a dose of innohep.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to use innohep

Do not take a double dose to make up for forgotten doses. If you have forgotten to take more than one dose, consult your doctor as soon as possible.

If you stop using innohep

If you stop using innohep, the effect of making the blood more fluid will cease. Do not stop using innohep without consulting your doctor or nurse.

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

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

Serious side effects:

Rarely, serious side effects are observed that require immediate medical attention during treatment with innohep. If you experience any of the following symptoms, consult your doctor immediately or go to the nearest hospital for emergency treatment.

Severe allergic reaction. Symptoms include sudden appearance of a severe skin rash, swelling of the throat, face, lips, or mouth, difficulty breathing.
Severe bleeding. Symptoms include urine that is red or brown, stools with a tar-like appearance, unusual bruising (very painful, extensive, or dark) and any bleeding that does not stop.

The following side effects have been observed with the administration of innohep:

Common: may affect up to 1 in 10 people

Bleeding. This can lead to complications such as anemia (a low number of red blood cells in the blood) or bruising.
Reactions at the injection site (including bruising, bleeding, pain, itching, redness, inflammation, and hardening of the injection site)

Uncommon: may affect up to 1 in 100 people

Thrombocytopenia (decrease in the number of platelets in the blood)
Hypersensitivity (allergic reaction)
Bruising and skin discoloration
Elevation of liver enzyme levels
Dermatitis (skin inflammation)
Rash and itching

Rare: may affect up to 1 in 1,000 people

Heparin-induced thrombocytopenia (decrease in the number of platelets in the blood due to heparin treatment)
Thrombocytosis (increase in the number of platelets in the blood)
Angioedema (swelling of the face, lips, and tongue)
Anaphylactic reaction (see above "Severe allergic reaction")
Hyperkalemia (elevated potassium levels in the blood)
Toxic skin rash
Necrosis of the skin
Hives
Osteoporosis, observed in long-term treatments
Priapism (prolonged, often painful, erection without previous sexual stimulation)

Pediatric population

Limited information is available, derived from a clinical trial and post-marketing data, indicating that the profile of adverse reactions in children and adolescents is comparable to that observed in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of innohep

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 carton after EXP. The expiry date refers to the last day of the month shown.
No special storage conditions are required.

Do not use this medicine if you notice turbidity or a precipitate in the syringe.
The solution may have a yellowish color during storage, but this does not affect the quality of the product, which is still safe to use.
Medicines should not be disposed of via wastewater or household waste. Place the empty container and any unused medicine in the SIGRE container at the pharmacy. If in doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of innohep

The active substance is tinzaparin sodium. Each ml of solution for injection contains 10,000 IU anti-Xa of tinzaparin sodium.

The other ingredients are sodium acetate, sodium hydroxide, and water for injections.

Appearance and packaging

Solution for injection.

Transparent glass syringes containing a clear or pale yellow solution that does not show turbidity or sediment when the syringe is left to stand.

Pack sizes:

0.45 ml (4,500 IU anti-Xa), packs of 2, 10, and 50 syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer

Laboratoires LEO S.A.

39 Route de Chartres

FR-28500 Vernouillet Cedex

France

Date of last revision of this leaflet: December 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

How much does INNOHEP 4,500 IU Anti-Xa/0.45 mL Injectable Solution in Syringes cost in Spain ( 2025)?

The average price of INNOHEP 4,500 IU Anti-Xa/0.45 mL Injectable Solution in Syringes in December, 2025 is around 51.16 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

fever, chills, fatigue and viral symptoms
cough, sore throat, nasal congestion, breathing discomfort
bronchitis and mild asthma flare-ups
nausea, diarrhoea, abdominal pain, digestive infections
rashes, allergic reactions, redness, insect bites
muscle or joint pain, mild injuries, sprains
headache, dizziness, migraine symptoms
stress-related symptoms, sleep disturbances
questions about test results and treatment plans
management of chronic conditions in stable phases

Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

Advanced Trauma Life Support (ATLS)
Basic and Advanced Cardiac Life Support (BLS/ACLS)
Pediatric Advanced Life Support (PALS)
Prehospital Trauma Life Support (PHTLS)
eFAST and critical care transthoracic echocardiography
aviation medicine

He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.

INNOHEP 4,500 IU Anti-Xa/0.45 mL Injectable Solution in Syringes

Andrei Popov

Yevgen Yakovenko

Andrei Popov

Yevgen Yakovenko