Fraxiparine 0.4 ml. 10 injection
Fraxiparine is a medicine that slows or prevents blood clotting. It is used for:
• prevent the formation of blood clots in the blood vessels of the legs or lungs. This may occur in patients recovering from surgery, or in patients in intensive care because they are of the bed and not move
* Treat clots that have formed in one of the deep veins of the legs or in one of the blood vessels of the lung
• prevent the formation of blood clots during kidney dialysis. Dialysis is a procedure that is used for purification of waste products from the blood in people with kidney failure.
♦ treatment of patients with heart problems such as chest pain due to unstable angina or after a heart attack.
2. BEFORE YOU USE Fraxiparine
Do not apply if Fraxiparine:
you are allergic to nadroparin or any of the other ingredients of Fraxiparine you had a reduced number of platelets (blood cells that help blood to clot) after pretreatment with Fraxiparine
- You have a bleeding or disease that reduces the ability of your blood to clot normally
- You have a condition that predisposes to bleeding, such as stomach ulcer you have a bacterial infection of the heart (bacterial endocarditis) have had a stroke due to cerebral hemorrhage
- You have severe kidney problems, unless you apply Fraxiparine to prevent clots.
Take special care with Fraxiparine:
In rare cases Fraxiparine may reduce the number of platelets in the blood. This can sometimes be severe. During treatment, you will have blood tests to check the status.
Fraxiparine is prescribed to prevent blood clots or destroy blood clots that have already formed. Due to the mechanism of action of the drug have an increased risk of bleeding. You are at risk if:
- You have severe liver disease, have kidney problems you have severe high blood pressure
- You had a condition predisposing to bleeding, such as stomach ulcer have an eye disorder that affects the blood vessels have a recent brain, spinal or ophthalmic surgery are taking other medicines that affect blood clotting>
If you have problems with bleeding should immediately contact a doctor.
Fraxiparine can increase the level of potassium in the blood. If you have a disease in which this can be a particular problem, such as diabetes, kidney disease or if you are taking other medicines, this action is necessary to monitor your blood tests to check the status.
If you are receiving spinal anesthesia or taking a sample of the spine (lumbar puncture) while using Fraxiparine, there is a risk of bleeding in the spinal cord in the area of the injection, which can be severe. Often you will be tested for problems during this procedure.
If you have a latex allergy before you start treatment with Fraxiparine should inform your doctor or pharmacist.
If you are pregnant you should inform your doctor or pharmacist before starting treatment with Fraxiparine. Your doctor will decide whether treatment with this medicine is suitable for you.
Breastfeeding is not recommended during treatment with Fraxiparine because it is not known whether Fraxiparine passes into breast milk and if so, whether it can harm your child. Discuss this with your doctor.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Should not be taken concomitantly with Fraxiparine other drugs that can affect blood clotting, unless prescribed by your doctor.
3. HOW TO USE Fraxiparine?
Fraxiparine usually administered by subcutaneous injection into the skin fold of the lower abdominal area. The drug should be injected intramuscularly. Usually medical specialist injection, but some patients may need to be self-dosing. If it is necessary to apply the medicine themselves, carefully follow the instructions for self-administration. Do not stop taking Fraxiparine until your doctor tells you.
Pre-filled syringes are available in different doses. Your doctor will decide which is right for you. The dose depends on whether Fraxiparine is used to treat or prevent clotting of your body weight and whether or not you have kidney problems.
Prevention of the formation of blood clots after surgery
Fraxiparine first dose will be given as a subcutaneous injection before surgery. If you are bone or joint surgery such as hip or knee replacement surgery, you will be given a second dose 12 hours after the operation. The drug will be given to you once a day, usually until you start moving. Treatment usually lasts for at least 10 days after the bone / joint surgery and 7 days after other operations.
Prevention of the formation of blood clots in patients in intensive care units
Fraxiparine will be administered by subcutaneous injection once a day while reducing the risk of forming blood clots.
Treatment of blood clots
Fraxiparine will be administered by subcutaneous injection twice a day, depending on the set dose. Treatment usually lasts for 10 days.
Prevent coagulation during kidney dialysis
If you apply Fraxiparine during dialysis (purification of waste products from the blood due to renal failure), the dose will be given at the beginning of each procedure in the pipe connected to the artery. This dose will be adjusted by your doctor depending on the risk for bleeding. Usual time of dialysis is 4:00. If the procedure is longer than 4 hours, may be administered second, smaller dose.
Treat chest pain or treatment after heart attack
Fraxiparine initially be applied as a single dose administered intravenously. Then administered by subcutaneous injection twice a day (every 12 hours). The usual duration of treatment is 6 days.
Instruction for self-administration of a pre-filled syringe
Always Fraxiparine exactly as prescribed by your doctor or nurse. Ask them for advice if you have any difficulties in injecting Fraxiparine.
1. Wash your hands thoroughly with soap and water. Wipe them with a cloth.
2. Sit or lie in a comfortable position.
The injection is given in the lower abdominal area. Alternate the left and right side of the abdomen for each injection.
3. Clean the injection site with a swab with alcohol.
4. Remove the cap that protects the needle. Discard the cap.
Do not touch the needle or allow it to come in contact with any surface before the injection.
A small air bubble in the syringe is normal. Do not try to remove this bubble before making the injection.
5. Gently pinch the cleaned skin to form a skin fold. Hold the fold between the thumb and the forefinger during the injection.
Hold the syringe firmly in place to hold. Insert the full length of the needle perpendicularly (at an angle of 90 °) into the skin fold.
6. Hold the syringe firmly in place to hold. Insert the full length of the needle perpendicularly (at an angle of 90 °) into the skin fold.
7. Inject the contents of the syringe by pushing the plunger to the end.
Remove the needle from the skin. The site of injection should not be massaged.
8. After the injection, use protective sleeve to prevent needle stick injuries. To do this, hold the syringe with one hand on the plastic cylinder, then use your other hand to pull strongly, keeping the place to grip with your fingers. This releases the protective cylinder. Slide the protective sleeve up the body of the syringe until it clicks and the cylinder block in position over the needle.
9. Discard the used syringe as your doctor or nurse has told you.
If you use more than the amount Fraxiparine
Seek advice to your doctor or pharmacist. If you forget to use Fraxiparine
Do not inject a double dose to make up the missed dose. If you are not sure what to do, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fraxiparine can cause side effects, although not everybody gets them.
Very common side effects
They may affect more than 1 in 10 patients applying Fraxiparine: bleeding. Any bleeding can be severe. If this happens you should immediately contact your doctor. Sometimes under the skin at the injection site may form small clots. They usually disappear after a few days.
Common side effects
They may affect more than 1 in 100 patients applying Fraxiparine:
skin reaction at the site of injection, increased levels of liver enzymes in the blood
Rare side effects
These may affect less than 1 in 1000 patients> applying Fraxiparine:
decreasing or increasing the number of platelets (blood cells necessary for blood clotting), which can cause problems in the coagulation accumulation of calcium in the skin at the injection site
Very rare side effects
These may affect less than 1 in 10,000 patients applying Fraxiparine:
- Allergic reactions such as skin rash, swelling of the face, including the mouth, lips, throat, wheezing and difficulty breathing, which may be life-threatening (anaphylaxis)
- Painful and red patches of skin around the injection site prolonged painful erection of the penis increase in the number of blood cells called eosinophils increased levels of potassium in the blood
If you get side effects
If you notice any side effects (even those not listed in this leaflet) or if any of the side effects gets serious, while using Fraxiparine, tell your doctor or pharmacist.
5. HOW TO STORE Fraxiparine?
Keep out of reach of children.
Do not freeze. Do not keep in the refrigerator as cold solution injections can be painful.
Do not store above 30 ° C.
Do not use Fraxiparine:
- After the expiry date stated on the label and carton if the pre-filled syringe is damaged if you notice any particles in the solution if the solution has changed color.
If any visual change, the solution should be discarded.
Pre-filled syringes are for single use only. Any unused solution for injection should be discarded.
Unused syringes should be disposed of as advised by your doctor or nurse.
6. FURTHER INFORMATION
The active ingredient is nadroparin calcium (nadroparin calcium) - 9500 anti-Xa IU / ml.
The other ingredients are calcium hydroxide solution or diluted hydrochloric acid and water for injections.
Fraxiparine looks like and contents of the pack?
Fraxiparine a clear to slightly opalescent, colorless to pale yellow solution, which is available in prefilled glass syringes: 0,2 ml solution for injection, equivalent to 1900 anti-Xa IU 0,3 ml solution for injection, equivalent to 2850 anti -Xa IU 0,4 ml solution for injection, equivalent to 3800 anti-Xa IU 0,6 ml solution for injection, equivalent to 5700 anti-Xa IU 0,8 ml solution for injection, equivalent to 7600 anti-Xa IU 1 ml injection, equivalent to 9500 anti-Xa IU
Each pack contains 10 Fraxiparine pre-filled syringes.