Fraxiparine 0.8 ml. 10 injection
Nadroparin calcium (calcium nadroparin) 9500 IU AXa / ml
Excipients: calcium hydroxide solution or dilute hydrochloric acid, water for injections.
Injection volume 0,8 ml in glass pre-filled syringes of 1ml. Each pack contains 10 syringes with security system against the prick.
IN WHAT CASES IS USED FRAXIPARINE
FRAXIPARINE is anti-clotting drug - anticoagulant. Belongs to the group of "low molecular weight" heparini.Predotvratyava appearance of thrombi (blood clots in a vein or artery) and re obrazuvane.Niskomolekulniyat heparin is used in:
• Prophylaxis of thromboembolic diseases:
- Related to operation
- In high risk patients (shortness of breath, and (or) a respiratory tract infection and (or) congestive heart failure), treated in intensive care
• Treatment of thromboembolic diseases
• Prevention of clotting in the extracorporeal (outside the body) circuit during hemodialysis.
• Treatment of unstable angina (angina) and heart attack without Q-wave
IN WHAT CASES SHOULD NOT BE USED FRAXIPARINE
This medicine SHOULD NOT BE USED in the following cases:
• a known allergy to the medication
• a significant reduction in the number of platelets (a type of blood cells responsible for blood clotting) in the past, due to the treatment with nadroparin
• serious disturbances in blood clotting
• damage which can lead to bleeding (for example ulcers)
• cerebral hemorrhage
• acute infective endocarditis (inflammation of the heart valves)
• severe renal impairment (except for use in hemodialysis)
The prevention of bleeding is important to respect the dosage and duration of treatment prescribed by your doctor (see precautions for use). Treatment with FRAXIPARINE requires frequent laboratory tests of blood and platelets (twice a week) .In rare cases, a significant decrease in platelet count during treatment. In such cases, discontinuation of therapy with heparin and the patient is put under close monitoring due to the risk of paradoxical thrombosis. Do not use in children.
NOT injected intramuscularly.
Injection technique must be strictly observed.
PRECAUTIONS FOR USE
During treatment with FRAXIPARINE risk of bleeding: the elderly, patients weighing less than 40 kg, liver failure, severe hypertension (high blood pressure), kidney failure, treatment lasting longer than 10 days, vascular violations of the choroid and retina (eye layers) after surgery of the brain, spinal cord or eyes, concomitant use of certain drugs (see drug Interactions) These conditions often require specific laboratory tests. Epidural or spinal anesthesia is not contraindicated for prophylaxis with FRAXIPARINE. We need to take the following precautions: a sufficiently long period between injection and placing FRAXIPARINE anesthetic, laboratory control. Inform your doctor if you have or have had kidney or liver disease, ulcers or other conditions predisposing to bleeding.
DRUG INTERACTIONS AND OTHER
Due to a possible risk of bleeding tell your doctor if you are taking the following medications: aspirin NSAIDs platelet aggregation inhibitors (abciximab, eptifibrate, iloprost, ticlopidine, tirofiban) dextrans (used in the ER) oral anticoagulants (antivitamin K). glucocorticosteroids
TO AVOID POSSIBLE DRUG INTERACTIONS Always tell your doctor about any drug taken during treatment with FRAXIPARINE.
Your doctor may adjust your treatment according to your condition.
Pregnancy and lactation
FRAXIPARINE use during pregnancy is not recommended unless the therapeutic benefits outweigh the possible risk.
Not recommended for use FRAXIPARINE during lactation. DRIVE AND USE MAShININyama data to affect the ability to drive and use machines. DOZIROVKADozirovkata is determined from the patient and of his body weight. 1 ml FRAXIPARINE corresponds to approximately nadroparin 9500 AHA IU.
AND METHOD OF ADMINISTRATION
Subcutaneous injection (except for hemodialysis).
DO NOT INJECT INTRAMUSCULAR!
FREQUENCY AND TIME OF APPLICATION
1 or 2 injections a day, depending on the case.
DURATION OF USE
Not to exceed 10 days.
In case of overdose
Due to the risk of bleeding immediately inform the treating lekar.Neutralizatsiya may be accomplished by intravenous injection of an appropriate dozaprotamin.
Like any drug and FRAXIPARINE can cause side effects in some patsienti.Nezabavno let your doctor or call an ambulance if you notice any of the following side effects:
• haemorrhage (bleeding) with varying intensity.
• thrombocytopenia (low platelet count in the blood) (see Precautions). Therefore regularly conducts clinical control.
• allergy to the drug if they experience any of the following rare severe allergy symptoms: sudden wheezing, chest tightness and swelling of the eyelids, face or lips swelling of the skin or hives, skin rash, itching, fever collapse
• rarely priapism (prolonged and sometimes painful erection of the penis, usually without sexual excitement).
Tell your doctor if you notice any of the following kezhelani reactions:
• severe skin reactions at the injection site (seen very rarely)
Can be observed the following side effects:
• hematoma at the injection site or "nodules" injection site disappear gradually and does not require discontinuation of treatment.
• temporary increase of some enzymes (transaminases)
• increase of eosinophilic leukocytes (cells in the blood), which is reversible after discontinuation of treatment
• reversible hyperkalemia (increased potassium) associated with suppression of aldosterone (a type of hormone) heparin, mainly in patients at risk.
INFORM YOUR DOCTOR ABOUT OTHER unexpected or nuisances, which are not mentioned in this leaflet.
Do not use after the expiry date shown on the packaging. Do not store above 30 ° C.
Do not freeze. Do not keep in the refrigerator as cold solution injections can be painful.
Keep the packaging until time of use. Keep out of reach of children!
INSTRUCTIONS FOR USE
Strictly follow the prescribed regimen.
Method and route of administration:
Subcutaneous injection (except for hemodialysis). Do not inject intramuscularly! Injection technique
• Do not expel air!
• The injection should be made preferably of a patient lying in the subcutaneous tissue, alternating left and right abdomen.
• The application site of injection should not be massaged.
The needle must be inserted fully, perpendicularly into the skin fold, which is formed in grip with the thumb and forefinger of the skin. Fold should be held throughout the injection.
Way of working with safety syringe FRAXIPARINE
FRAXIPARINE syringe has a secure system for protection from puncture after injection of the drug.
About syringe plastic sleeve that covers the glass part. After injection of the medicine the sleeve must be pulled over the needle to prevent needle sticks. This is accomplished in the following manner:
• With one hand syringe gets to ring in part to the plunger with the other hand cuff is pulled in the direction of the needle. Cuff pulling, until you hear a click. Thus the needle is securely protected and no risk of puncture.
During pulling the skirt do not direct the needle to the body! Safety syringe can be disposed of as normal waste.
Recommendations for use
FRAXIPARINE solution for injection should be visually inspected before use for particles or discoloration. If there is a change in appearance, the solution should be izhvarli.Sprintsovkite are intended for single use only and any unused solution from each syringe should be discarded. Solutions should not be mixed with other products or redistributed.