FRAGMIN 10000IU. 10 ampoules
FRAGMIN belongs to a group of medicines called low molecular weight heparin or antiplatelet drugs that help prevent blood clots. FRAGMIN acts on substances that are found in the blood and cause coagulation. Besides FRAGMIN prevents the formation of clots, it can also help to break the clots that have already formed in blood vessels.
FRAGMIN can be used in patients in hemodialysis or hemofiltration to prevent clotting in the pipes of the apparatus.
FRAGMIN is also used for the treatment of conditions known as acute deep venous thrombosis, pulmonary embolism and unstable forms of ischemic heart disease. Deep vein thrombosis is a condition in which blood clots in the legs and in the pulmonary embolism clot entering the lungs. In ischemic heart disease heart arteries narrow due to plaque deposition in fat stores. This reduces blood flow to the heart (heart reduced feeding). In the unstable forms of coronary artery disease either of these plates breaks and / or a clot is formed, thereby hindering the blood supply to the heart. In such patients is more likely to get a heart attack if not treated with antiplatelet drugs such as FRAGMIN.
FRAGMIN is used to prevent thrombosis during surgery, and in patients with limited mobility due to severe medical conditions. FRAGMIN is used in long-term treatment of symptomatic venous thromboembolism (VTE), manifesting as deep venous thrombosis or pulmonary embolism to reduce the recurrence of VTE in patients with cancer.
2. What you need to know before you use FRAGMIN?
Do not use FRAGMIN
- If you are allergic (hypersensitive) to dalteparin or any of the other ingredients of FRAGMIN or similar product (heparin or LMWH).
- If you have a stomach ulcer or duodenal, stroke or other bleeding;
- If you have serious bleeding disorder;
- If you have infective endocarditis (inflammation of the lining of the heart);
- Have recently had surgery or trauma to the central nervous system, eyes and / or ears;
- If you are or have to be made your epidural or spinal anesthesia (kind of anesthesia) or spinal puncture.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using FRAGMIN. Have thrombocytopenia. This is a condition where there are fewer clotting cells called platelets, resulting in the bleed can be more easily; if you have uncontrolled high blood pressure; severe hepatic or renal failure; have retinopathy (eye damage) due to diabetes or high blood pressure; If you have recently operated or suffer from conditions under which suggested an increased risk of bleeding; if you take the so-called non-steroidal anti-inflammatory drugs (eg. aspirin) Children and adolescents
The dosing recommendations for children are based on clinical experience; there are limited data from clinical studies that will help your doctor to calculate the dose FRAGMIN.
Other medicines and FRAGMIN
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Co-administration of drugs affecting blood as thrombolytic agents, other anti-clotting drugs, nonsteroidal antiinflammatory drugs (commonly used for the treatment of pain and inflammation in various conditions), vitamin K antagonists and platelet inhibitors can enhance the anticoagulant effect of FRAGMIN, however, if you are treated with FRAGMIN for unstable forms of ischemic heart disease, your doctor will probably recommend that you take low-dose aspirin and.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine. Epidural anesthesia during childbirth is absolutely contraindicated in women who were treated with high doses of FRAGMIN.
FRAGMIN should not be used during breast-feeding, unless your doctor recommends otherwise.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
FRAGMIN does not affect the ability to drive and use machines. FRAGMIN contains
FRAGMIN 2500 IU anti-Xa / 0,2 ml solution for injection and FRAGMIN 10 000 IU anti-Xa / ml solution for injection contains sodium chloride less than 1 mmol (23 mg) per dose, ie contains virtually no sodium.
FRAGMIN 25 000 IU anti-Xa / ml injection solution contains benzyl alcohol. Should not be given to premature babies or neonates.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
3. How to use FRAGMIN?
Always use this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
This medicine will be given by a doctor or nurse. FRAGMIN is administered subcutaneously or intravenously. Should not be administered intramuscularly.
FRAGMIN dose that will be given to you depends on your particular situation and the likelihood of clot formation.
If you are being treated for deep vein thrombosis or pulmonary embolism will be given a subcutaneous injection FRAGMIN. The dose that you will be given 200 IU / kg body weight once daily or 100 IU / kg body weight twice daily. If you are on hemodialysis or hemofiltration, the drug will be injected intravenously (into a vein). In patients with chronic kidney problems and patients without risk of bleeding, where it lasts more than 4 hours, you will usually be given a starting dose of 30-40 IU / kg bodyweight. This will be followed by an infusion of 10-15 IU / kg each hour. If your procedure lasts less than four hours may be given the same dosage or you are given a single injection of 5 000IU. In patients with acute renal failure or patients at high risk of bleeding, the usual dose is 5-10 IU / kg body weight, followed by 4-5 IU / kg every hour.
For thrombosis prophylaxis in surgery FRAGMIN is administered subcutaneously. In patients at risk for a blood clot, the usual dose is 2 500IU to two hours before surgery and 2 500IU of each following morning. This lasts typically 5 to 7 days until the patient mobilization. Other patients may have an increased risk of blood clots (additional risk factors, eg. Malignancy). In such patients, the normal dose is 2 500IU to two hours prior to surgery and 2 500IU 8 to 12 hours later, but no sooner than 4 hours after the operation and 5000 IU subcutaneously every next morning. An alternative could be applied 5000 IU subcutaneously the evening before surgery and after surgery to apply 5000 IU every night. This treatment also usually takes 5 to 7 days.
Orthopedic procedures (eg. Hip replacement) FRAGMIN normally used to 5 weeks after surgery, after surgery apply 5000 IU each dandy.
In patients with prolonged restriction on locomotor activity was 5000 IU FRAGMIN administered subcutaneously once a day, usually 12 to 14 days or longer.
In the treatment of unstable forms of ischemic heart disease is administered 120 IU / kg body weight subcutaneously every 12 hours. The maximum dose for 12 hours was 10 000IU. It is recommended that concurrent treatment with acetylsalicylic acid (75 to 325 mg / day). In long-term treatment of symptomatic venous thromboembolism reduction of recurrence of VTE in patients with cancer FRAGMIN apply special monthly scheme using pre-filled syringes with single doses. Medical staff treat you may decide that it is necessary to take blood samples to monitor the outcome of treatment with FRAGMIN. If you have any questions, ask your doctor or nurse.
Use in children and adolescents
The dose will be based both on the age and weight of the child. Younger children may need a little less FRAGMIN calculated per kilogram of body weight than adults. Your doctor will calculate the correct dose for you. The medical team can take blood samples during treatment to monitor the effects of FRAGMIN.
If you use more than the amount of FRAGMIN
This medicine will be given by medical personnel. Therefore, the likelihood of overdose is unlikely. However, if you suspect that you are given a greater amount, tell your doctor immediately. Your doctor will probably ask you an injection of protamine as an antidote.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Blood and lymphatic system:
Common: reversible, mild thrombocytopenia (type I)
Immune system disorders:
Common: Transient elevations in liver transaminases
Skin and subcutaneous tissue disorders:
Rare: skin necrosis, transient alopecia (hair loss)
General disorders and administration site conditions:
Common: subcutaneous hematoma at the injection site, pain at the injection site
Other reported adverse reactions are immunologically-mediated heparin-induced thrombocytopenia (type II) with or without accompanying thrombotic complications; skin necrosis; rash, anaphylactic reactions; spinal or epidural hematoma; retroperitoneal (abdominal) and intracranial haemorrhage, some of which were fatal. Particular attention is necessary if you are treated with FRAGMIN and you are spinal (dorsal) or epidural anesthesia (anesthesia). Make sure your doctor knows about your treatment.
Additional side effects in children
Expected adverse reactions in children are the same as in adults, but there is limited information on possible side effects of long-term use in children.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.
5. How to store FRAGMIN?
Keep out of the reach and sight of children. Do not store above 25 ° C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
The active substance is dalteparin sodium
The other ingredients are water for injection, sodium hydroxide and hydrochloric acid
Fragmin 2500IU anti-Xa / 0,2 ml Fragmin and 10 000IU anti-Xa / ml injection solution containing sodium and chloride.
Fragmin 25 000IU anti-Xa / ml contains benzyl alcohol.
FRAGMIN looks like and contents of the pack?
FRAGMIN 25001U anti-Xa / 0,2 ml - pre-filled syringe containing a solution for injection of 2500 IU / 0,2 ml dalteparin sodium, with or without soft needle guard. FRAGMIN 5000IU anti-Xa / 0,2 ml - pre-filled syringe containing a solution for injection of 5000 IU / 0,2 ml dalteparin sodium, with or without soft needle guard. FRAGMIN 10 000IU anti-Xa / 1 ml - ampoule injection of 10000IU / 1 ml of dalteparin sodium, with or without soft needle guard.
FRAGMIN 7500IU anti-Xa / 0,3 ml - single dose syringe containing a solution for injection of 7500 IU / 0,3 ml dalteparin sodium, with or without soft needle guard. FRAGMIN 10 000 IU anti-Xa / 0,4 ml - single dose syringe containing a solution for injection of 10,000 IU / 0,4 ml dalteparin sodium, with or without soft needle guard.
FRAGMIN 12 500 IU anti-Xa / 0,5 ml - single dose syringe containing a solution for injection of 12 500 IU / 0,5 ml dalteparin sodium, with or without soft needle guard. FRAGMIN 15 000 IU anti-Xa / 0,6 ml - single dose syringe containing a solution for injection 15 000 IU / 0,6 ml dalteparin sodium, with or without soft needle guard. FRAGMIN 18 000 IU anti-Xa / 0,72 ml - single dose syringe containing a solution for injection, 18 000 IU / 0,72 ml dalteparin sodium, with or without soft needle guard.
FRAGMIN 25 000 IU anti-Xa / 1 ml, 4 ml - vial containing injection of 25,000 IU / ml dalteparin sodium with or without soft needle guard.
FRAGMIN 2500 IU anti-Xa / 0,2 ml is available in pack of 10 pieces syringes FRAGMIN 5000 IU anti-Xa 0,2 ml is available in pack of 10 pieces syringes FRAGMIN 10 000IU anti-Xa / 1 ml is available in pack of 10 ampoules. FRAGMIN 7500 IU anti-Xa / 0,3 ml is available in pack of 2 pieces syringes FRAGMIN 10 000 IU anti-Xa / 0,4 ml is available in pack of 2 pieces syringes.
FRAGMIN 12 500 IU anti-Xa / 0,5 ml is available in pack of 2 pieces syringes. FRAGMIN 15 000 IU anti-Xa / 0,6 ml is available in pack of 2 pieces syringes.
FRAGMIN 18 000 IU anti-Xa / 0,72 ml is available in pack of 2 pieces syringes.
FRAGMIN 25 000 IU anti-Xa / 1 ml, 4 ml is available in a 1 vial pack. Not all pack sizes may be marketed.