FRAGMIN PACKAGE INSERT PDF

General Notes: Dalteparin sodium is administered by subcutaneous Sub-Q injection. It must not be administered by intramuscular injection. About Us Disclaimer Contact Us. Toggle navigation. Please enter text to search.

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It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. It is used in the following conditions:. If the product has expired or is damaged, return it to your pharmacist for disposal. FRAGMIN is not recommended for use in children, as its safety and effectiveness have not been established in children. Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have an allergy to latex natural rubber. The needle shield on the pre-filled syringe may contain latex. Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

You may need to use different amounts of your medicine or you may need to use different medicines. Your doctor or pharmacist will advise you. The dose and length of treatment will depend on your condition.

Your doctor or nurse will usually give you your injection. If you are being treated for deep vein thrombosis, your doctor may tell you to start taking another oral medicine to prevent blood clots, such as warfarin tablets.

If you are being treated for unstable heart disease, e. In that case, your doctor or nurse will teach you how to self-inject before you leave the hospital. Do not expel the air bubble from the syringe before injection. This should ensure delivery of the full dose. The injection is given under the skin.

You can inject yourself in either your stomach or the fleshiest part of your upper buttock. Your doctor or nurse will tell you which of these two areas is better for you to use. Whichever area you use, try to make sure that you inject yourself in slightly different spots each time to avoid soreness at the injection site. Before you inject, make sure that the injection site is clean by wiping the area with an antiseptic swab, or by washing it with soap and water and patting it dry with a clean towel.

If you are injecting yourself in the stomach, you will need to lift up a fold of skin to make a slight bulge, as the layer of fat may be quite thin. Keep a firm grip of the skin throughout the whole injection without pinching yourself too tightly. If you are injecting yourself in the buttock, there is no need to lift a fold of skin, as the layer of fat is thick enough. Hold the base of the rubber cover that protects the needle, twist to remove from the needle. Insert the needle into the skin vertically, as far as it will go.

Press on the plunger and withdraw the needle when you have injected the whole content of the syringe. Dispose of the used syringe and needle in a safe manner. If you have any questions, ask your doctor or nurse for help. If more than 6 hours has passed, give yourself the next injection when it is time to do so.

If more than 12 hours have passed, give yourself the next injection when it is time to do so. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you are going to have surgery, tell your doctor, anaesthetist or dentist that you are being treated with this medicine.

It may affect other medicines used during surgery. Tell your doctor that you are using FRAGMIN if you are going to have a local anaesthetic or an anaesthetic injection in your back spinal or epidural injection. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects. Tell your doctor or pharmacist if you notice any of the following side effects and they worry you:. If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:.

The above list includes rare but very serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor, nurse or pharmacist immediately if you notice anything that is making you feel unwell during or after treatment with FRAGMIN. Other side effects not listed above may also occur in some patients. Some of these side effects can be found only when your doctor does tests from time to time to check your progress.

Keep the syringes in the pack until it is time to use them. If you take the syringes out of the pack, they may not keep well. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines. Discard any unused solution. A solution for infusion should be used within 12 hours of its preparation. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Dispose of the used syringe and needle safely in a 'sharps' container or similar puncture proof container made of hard plastic. If your doctor tells you to stop using FRAGMIN or you find that the syringes have passed their expiry date, ask your doctor or pharmacist what to do with any that are left over.

The solution is contained in a pre-filled glass syringe. A non-removable needle is attached to each syringe. The 7, IU and 10, IU graduated syringes have measurement markings to allow the dose to be adjusted.

One unit anti-Xa of Fragmin is equivalent in effect to the activity of one unit of the 1st international standard for low molecular weight heparin with regard to inhibition of coagulation factor Xa in plasma. Chemical structure. CAS number. The 0. For the full list of excipients, see Section 6. Mechanism of action. Fragmin is composed of molecules with and without the specially characterised pentasaccharide the antithrombin binding site.

Fragmin, therefore, acts antithrombotically by accelerating the rate of the neutralisation of certain activated coagulation factors, largely factor Xa, but also factor XIIa and kallikrein by antithrombin. Other mechanisms may also be involved.

Coagulation time, e. Compared with heparin, Fragmin has relatively little effect on platelet function and adhesion and thus has little effect on primary haemostasis. In addition, some of the antithrombotic properties of Fragmin are thought to be mediated through the effect on the vessel wall or the fibrinolytic system.

Clinical trials. Unstable coronary artery disease unstable angina and non-ST-elevation myocardial infarction. In this trial, unstable angina was defined to include only angina with ECG changes.

All patients, except when contraindicated, were treated concurrently with aspirin 75 mg once daily and beta blockers. Treatment was initiated within 72 hours of the event the majority of patients received treatment within 24 hours and continued for 5 to 8 days. A total of patients were enrolled and treated; received Fragmin and received placebo. The mean age of the study population was 68 years range 40 to 90 years and the majority of patients were white The combined incidence of the double endpoint of death or myocardial infarction was lower for Fragmin compared with placebo at 6 days after initiation of therapy.

These results were observed in an analysis of all randomised and all treated patients. The combined incidence of death, myocardial infarction MI , need for intravenous i. All patients, except when contraindicated, were treated concurrently with aspirin to mg per day. Of the total enrolled study population of patients, patients were treated; received Fragmin and received heparin. The mean age of the study population was 64 years range 25 to 92 years and the majority of patients were white The incidence of the combined triple endpoint of death, myocardial infarction, or recurrent angina during this 1 week treatment period 5 to 8 days was 9.

There are insufficient data regarding the benefits from treatment beyond 6 days. Prolonged thromboprophylaxis in orthopaedic surgery. Two placebo controlled studies conducted in Denmark and Norway with a total of patients have been performed to study the effect and safety of extended thromboprophylaxis after hip replacement surgery.

Fragmin 5, IU was given subcutaneously once daily up to 35 days postoperatively and was compared with placebo. In both studies Fragmin achieved a significant reduction of the frequency of phlebographically detected venous thrombosis. None of the patients receiving Fragmin developed pulmonary embolism PE in either of the studies, while two cases of PE were reported in the placebo group of the Norwegian study. The difference in the incidence of PE between the Fragmin and placebo groups was not significant.

There were no serious haemorrhagic complications. Patients with cancer and acute symptomatic venous thromboembolism. Patients were evaluated for recurrence of symptomatic venous thromboembolism VTE every two weeks for six months.

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It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. It is used in the following conditions:. If the product has expired or is damaged, return it to your pharmacist for disposal. FRAGMIN is not recommended for use in children, as its safety and effectiveness have not been established in children.

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Consumer Medicine Information. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. If you have any concerns about this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again later.

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DALTEPARIN SODIUM 7 500 IU/0.3ML SOLUTION FOR INJECTION

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non steroidal anti-inflammatory drugs NSAIDs , platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

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