10000 anti-Xa IU / ml, solution for injection
tinzaparinnatrium
1. What Innohep is and what it is used for
Innohep is a blood-thinning drug that inhibits the blood’s natural ability to coagulate. Innohep is used for:
- to prevent blood clots in adults before and after surgery.
- to prevent blood clots in adults who have an increased risk of blood clots e.g. due to acute illness with limited mobility.
- to prevent blood clots in connection with dialysis or filtration of blood. During dialysis, the blood is purified from waste products and fluids through a dialysis machine and a dialysis filter, which acts as a kind of artificial kidney.
If the doctor has specified another area of use, it is the doctor’s instructions must be followed.
2. What you need to know before you use Innohep
Do not use Innohep
- in case of increased risk of bleeding (general or local), infection of the heart, cerebral haemorrhage or bleeding stomach ulcers
- if you are allergic to tinzaparin or any of the other ingredients of this medicine (listed in section 6)
- to infants, see Innohep contains benzyl alcohol and sodium )
Warnings and cautions
Talk to your doctor or pharmacist before using Innohep.
- in severe renal impairment
- if you have an increased risk of bleeding or if you have a lack of platelets ( thrombocytopenia )
- if you have diabetes
- if you have asthma
- if you have elevated potassium levels in your blood
- in spinal cord tests or spinal anesthesia
- implanted heart valve prosthesis
- if you are elderly with renal impairment
Innohep should not be given to muscle. Due to the risk of bleeding under the skin, other medicines given to a muscle should not be given at the same time.
For spinal cord tests or spinal anesthesia, at least 12 hours must elapse between the administration of Innohep and the procedure being performed. Innohep should not be given until at least 4-6 hours after the end of the procedure.
Patients treated with Innohep who receive spinal anesthesia should be closely monitored to detect any effects on the spinal cord in the form of muscle weakness or impaired sensation.
Children
Innohep vial in vial contains the preservative benzyl alcohol. It May not be given to premature babies or newborns and should not be given to children under 3 years of age. Benzyl alcohol can cause poisoning and allergic reactions in infants and children under 3 years of age. See section Innohep contains benzyl alcohol and sodium for further information.
Other medicines and Innohep
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may affect the effect of Innohep.
Some medicines affect the blood and its ability to coagulate ( coagulation ). Because Innohep makes bleeding easier, combination with these medicines may increase the risk of bleeding. Talk to your doctor if you are taking any of the following medicines:
- Drugs used to treat inflammation or pain, especially non-steroidal anti-inflammatory drugs ( NSAIDs ) such as acetylsalicylic acid or ibuprofen
- Drugs used to resolve blood clots (blood thinning)
- Drugs that block the uptake of vitamin K (so-called vitamin K antagonists )
- Drugs that regulate blood coagulation using activated protein C.
- Anticoagulants with direct-acting factor Xa and IIa inhibitors
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.
Treatment of blood clots in pregnant women requires the involvement of specialist doctors.
Innohep can be used throughout pregnancy if your doctor thinks it is medically justified.
Tinzaparin does not pass into the placenta.
Innohep should not be used by pregnant women with a heart valve prosthesis.
Innohep solution for injection in vials contains benzyl alcohol (see section Innohep contains benzyl alcohol and sodium for further information). This preservative can pass through the placenta. Therefore, use Innohep pre-filled syringes that do not contain the preservative benzyl alcohol during pregnancy.
It is unknown whether tinzaparin is excreted in human milk. Talk to your doctor before using Innohep while breastfeeding.
There are no studies on the effects of Innohep on fertility.
Driving and using machines
Innohep has no or negligible effect on the ability to drive and use machines.
Innohep contains benzyl alcohol and sodium
Innohep 10000 IU / ml vial contains benzyl alcohol, sodium acetate trihydrate, and sodium hydroxide.
Benzyl alcohol:
May not be given to premature babies or newborns. May cause poisoning or allergic reactions in infants and children under 3 years of age.
- 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 (“Gasping syndrome”) in young children. Do not use this medicine for more than a week in children (younger than 3 years), unless your doctor or pharmacist has recommended it.
- If you are pregnant or breast-feeding, 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 ).
- If you have impaired liver function or kidney function, consult your doctor or pharmacist if you are taking this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free.
3. How to use Innohep
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Your doctor may take blood samples from you to evaluate the effect of Innohep.
To prevent blood clots in your veins
Innohep should be injected under the skin ( subcutaneous injection ). The dose and duration of treatment depend on the type of surgery or illness you have.
Your doctor will prescribe the right dose for you and tell you how long to take Innohep.
To prevent blood clots in connection with dialysis or filtration of blood
Innohep is injected into the tubes of the dialysis machine or into your vein. Dose one depends on how long dialysis one lasts.
Innohep in a vial is intended for hospital use and is given by a doctor or nurse.
If you use more Innohep 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.
Overdose can result in bleeding.
If you forget to use Innohep
Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Innohep and contact your doctor immediately if you get any of the following side effects:
- Angioedema (affects up to 1 in 1,000 people). Symptoms of angioedema are:
- Swelling of the face, tongue or throat
- Difficulty swallowing
- Hives and difficulty breathing
- An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals (occurs in up to 1 in 1000 users).
Other side effects:
Common (affects up to 1 in 10 people):
Injection site reactions (pain, itching, swelling, bruising). Bleeding. Reddening of the skin. Anemia.
Uncommon (affects up to 1 in 100 people):
Increased or decreased platelet count. Hypersensitivity. Bruises. Redness. Transient liver effects. Rash. Inflammation of the skin. Itching.
Rare (affects up to 1 in 1,000 people):
Allergic reactions.
Hives, local tissue death. Osteoporosis. Increased potassium content in the blood. Painful persistent erection.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
5. How to store Innohep
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Chemical and physical in-use stability has been demonstrated for 28 days at 30 ° C.
From a microbiological point of view, the product, once opened, can be stored for a maximum of 28 days at 30 ° C. Other storage times or storage conditions are the responsibility of the user.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Do not use if the solution for injection is cloudy or precipitation can be observed. The solution for injection may turn yellow during storage but is still useful.
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 tinzaparin sodium. One ml contains 10,000 anti-Xa IU / ml tinzaparin sodium (equivalent to 120 mg tinzaparin) IU = IU (International Units).
Other ingredients are:
Sodium acetate trihydrate, sodium hydroxide for pH adjustment, water for injections, benzyl alcohol ( preservative ).
What the medicine looks like and contents of the pack
Innohep is a colorless / slightly yellowish solution.
Glass vials with rubber stoppers:
10000 anti-Xa IU / ml: 10 × 2 ml, 10 × 5 ml
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
LEO Pharma AB, Box 404, 201 24 Malmö. Tel. 040-35 22 00.
Manufacturer
Laboratories LEO, 39 Route de Chartres, 28500 Vernouillet, France