FRAGMIN PI PDF

Fragmin is used to prevent blood clots forming in blood vessels. It is used in the following conditions:. Fragmin is also used to prevent blood clotting during haemodialysis , a procedure that uses a machine to remove waste products from the blood in people with kidney failure. Ask your doctor if you have any questions about why Fragmin has been prescribed for you.

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Fragmin is used to prevent blood clots forming in blood vessels. It is used in the following conditions:. Fragmin is also used to prevent blood clotting during haemodialysis , a procedure that uses a machine to remove waste products from the blood in people with kidney failure. Ask your doctor if you have any questions about why Fragmin has been prescribed for you. Your doctor may have prescribed Fragmin for another reason. Fragmin belongs to a group of medicines called low molecular weight heparins LMWHs.

These medicines work by reducing blood clotting activity. Fragmin is composed of molecules with and without the specially characterised pentasaccharide the antithrombin binding site. Fragmin, therefore, acts anti-thrombotically 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. Fragmin contains dalteparin sodium as the active ingredient.

Some of the symptoms of allergy include skin rash, itching, difficulty breathing, and swelling of the face. Do not use Fragmin after the expiry date printed on the pack. Do not use Fragmin if the packaging is torn or shows signs of tampering.

If the product has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start treatment with Fragmin, talk to your doctor or pharmacist. Fragmin is not recommended for use in children, as its safety and effectiveness have not been established in children. Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

Fragmin is not recommended for use during pregnancy or breastfeeding. Your doctor can discuss with you the risks and benefits involved. If you have not told your doctor or pharmacist about any of the above, tell them before you start treatment with Fragmin.

Tell your doctor or pharmacist if you are taking other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. If you are taking any of these medicines while using Fragmin, your doctor will need to carefully monitor your blood clotting factors. These medicines may be affected by Fragmin or may affect how well it works. 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. Your doctor or pharmacist has a complete list of medicines to be careful with or avoid while using Fragmin. Fragmin is given by injection, either under the skin subcutaneously or into a vein intravenously.

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 certain conditions, you might have to use Fragmin after you have left the hospital. In that case, your doctor or nurse will teach you how to self-inject before you leave the hospital.

To inject Fragmin, you should be sitting or lying down. 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 on 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 it is less than 6 hours since you should have injected, give yourself an injection and then continue as usual. If more than 6 hours has passed, give yourself the next injection when it is time to do so. If it is less than 12 hours since you should have injected, give yourself an injection as soon as you can and then continue as usual.

If more than 12 hours have passed, give yourself the next injection when it is time to do so. Immediately telephone the Poisons Information Centre telephone 13 11 26 or go to the Accident and Emergency department at your nearest hospital if you think that you or anyone else may have used too much Fragmin. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention. Keep telephone numbers of these facilities handy. If you are about to be started on any new medicine, remind your doctor, dentist, and pharmacist that you are using Fragmin. If you are going to have surgery, tell your doctor, anaesthetist or dentist that you are being treated with this medicine. 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. Fragmin is not interchangeable with other low molecular weight heparins LMWHs or heparin products.

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 store Fragmin or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill 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. Keep Fragmin where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

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. Fragmin is a Schedule 4 — prescription only medicine. Tell your doctor, pharmacist or nurse as soon as possible if you do not feel well during or after treatment with Fragmin.

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.

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. View more information about myVMC. Please be aware that we do not give advice on your individual medical condition, if you want advice please see your treating physician. Parenting information is available at Parenthub. Are you a Health Professional? Jump over to the doctors only platform.

Click Here. Generic Name: dalteparin sodium Product Name: Fragmin Indication: What Fragmin is used for Fragmin is used to prevent blood clots forming in blood vessels. It is used in the following conditions: Treatment of deep vein thrombosis also known as DVT, a blood clot in the veins of the leg ; Treatment of DVT and pulmonary embolism blood clot in the veins of the lungs for up to 6 months in patients with certain types of cancers; Prevention of DVT before and after an operation; Treatment of unstable heart disease e.

Dose advice: How to use Fragmin Before you use Fragmin When you must not use it Do not use Fragmin if you have an allergy to: Any medicine containing dalteparin sodium; Any other low molecular weight heparin or similar medicines such as heparin; Pork products; Any of the ingredients listed here.

Do not use Fragmin if you have or ever had any of the following medical conditions: Low platelet count caused by heparin; Stomach or bowel problems such as ulcers or ulcerative colitis; A certain type of stroke caused by bleeding in the brain; Uncontrolled high blood pressure; Severe problems with blood clotting; Infection and inflammation of the heart valves.

Do not use Fragmin: Following an injury or operation on your brain, spinal cord, eyes or ears; If you are being treated for deep vein thrombosis a blood clot in the veins of the leg , pulmonary embolism blood clot that has traveled to the lungs or unstable heart disease e. Before you start to use it Tell your doctor if you have allergies to any other medicines, foods, preservatives, or dyes. Tell your doctor if you have or have had any of the following: Eye disease related to diabetes or high blood pressure; Kidney or liver disease; Thinning of the bones osteoporosis ; Problems with bleeding or bruising; An artificial heart valve.

Taking other medicines Tell your doctor or pharmacist if you are taking other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may alter the effects of Fragmin. These include: Medicines or substances used to prevent or treat blood clots; Dextran, a medicine used to treat shock, which occurs when you have dangerously low blood pressure; Aspirin and non-steroidal anti-inflammatory drugs NSAIDs , medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis; Probenecid, a medicine used to treat gout; Medicines used to treat some cancers; Ethacrynic acid, a medicine used to help the kidneys get rid of salt and water by increasing the amount of urine produced; Antihistamines, medicines used to prevent or relieve the symptoms of allergy, hay fever or rashes; Digoxin, a medicine used to treat heart failure; Tetracycline, an antibiotic used to treat some infections; Medicines that contain ascorbic acid vitamin C.

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. Cumulative data of Day 1 to 7 has been reported. Percentage of participants who achieved the prespecified level during the dose adjustment phase were reported in this outcome measure. Progression of VTE: Progression of clot burden in terms of severity of occlusion, or involvement of new venous segments at any time after the initial diagnosis. DVT is a blood clot in the deep veins of the leg.

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Study record managers: refer to the Data Element Definitions if submitting registration or results information. About patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

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