Fragmin

Fragmin (Dalteparin) is given by subcutaneous (under the skin) injection, usually in the lower abdominal area. Sometimes, in a hospital setting, Fragmin (Dalteparin) is given intravenously (into the vein). The recommended dose and route of administration of Fragmin (Dalteparin) varies according to the individual and the condition being treated. Your doctor will order blood tests to determine how effective the medication is for you and will adjust the dose based on the effect of Fragmin (Dalteparin).

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

If you are injecting the medication yourself, your doctor or health care professional will show you how to inject the medication properly. If you have any questions about how to use your medication, contact your doctor or health care professional.

Do not use the medication if the syringe is leaky, or if the medication appears cloudy or discoloured.

To use the medication:

• Wash your hands and clean the injection site with an alcohol swab. Do not rub the injection site.
• Remove the needle shield. Avoid pressing on the syringe plunger so as not to lose any of the syringe content. Hold the syringe like a pencil.
• Pinch a fold of skin in the lower (left or right) region of your abdomen. Choose a different injection site for each injection so that you are not always injecting the same area.
• While holding the skin fold, insert the entire needle into the skin fold vertically and press the syringe plunger down completely.
• Remove the needle and let go of the syringe plunger. (The syringe will move into the device until the needle is guarded.)
• Apply pressure to the injection site with the alcohol swab for 5 to 10 seconds. Do not rub the injection site.
• Safely dispose of the used syringe device in approved containers, and keep it out of the reach of children.

It is important to use Fragmin (Dalteparin) exactly as prescribed by your doctor. If you miss a dose, inject it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not inject a double dose for to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Fragmin (Dalteparin) at room temperature, protect it from light and moisture, and keep it out of the reach of children. If you are using the multiple dose vial, the medication must be used within 14 days after first use.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause pain at the injection site; it may cause bruising at the injection site; it may reduce your blood clotting ability. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Ampules

Each mL of solution for injection contains 10,000 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, sodium chloride, and water for injection.

Multidose vials

Each multidose vial contains Fragmin (Dalteparin) sodium at 25,000 IU/mL. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, benzyl alcohol, sodium chloride, and water for injection.

Prefilled syringes

2,500 IU/0.2 mL
Each syringe contains 2,500 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, sodium chloride, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

3,500 IU/0.28 mL
Each syringe contains 3,500 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

5,000 IU/0.2 mL
Each syringe contains 5,000 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

7,500 IU/0.3 mL
Each syringe contains 7,500 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

10,000 IU/0.4 mL
Each syringe contains 10,000 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

12,500 IU/0.5 mL
Each syringe contains 12,500 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

15,000 IU/0.6 mL
Each syringe contains 15,000 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

16, 500 IU/0.66 mL
Each syringe contains 16,000 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

18,000 IU/0.72 mL
Each syringe contains 18,000 IU of Fragmin (Dalteparin) sodium. Nonmedicinal ingredients: hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The solution does not contain preservatives and is intended for use as a single-dose injection.

Do not use Fragmin (Dalteparin) if you:

• are allergic to Fragmin (Dalteparin) or any ingredients of the medication
• are allergic to other low-molecular-weight heparins or heparin
• are allergic to pork products
• are actively bleeding
• are receiving spinal or epidural anesthesia and will be needing multiple high doses of Fragmin (Dalteparin)
• have a history of severe low platelet count caused by heparin
• have a bacterial infection of the heart
• have a history of cerebral hemorrhage (bleeding in or against the brain)
• have a history of thrombocytopenia (a decreased platelet count)
• have a severe blood clotting disorder
• have an active gastric (stomach) or duodenal (intestinal) ulcer
• have eye or Retin A problems due to bleeding or Diabetes
• have injuries and operations on the brain, spinal cord, eyes, or ears
• have other conditions that put you at an increased risk of bleeding
• have severe uncontrolled high blood pressure

There may be an interaction between Fragmin (Dalteparin) and any of the following:

• acetylsalicylic acid (Asa)
• Aliskiren
• angiotensin-converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• Apixaban
• Celecoxib
• chamomile
• dabigatran
• Dasatinib
• Deferasirox
• Dipyridamole
• Edoxaban
• Eplerenone
• Epoprostenol
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• evening primrose
• feverfew
• garlic
• ginger
• ginseng
• green tea
• Ibrutinib
• Mesalamine
• mifepristone
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, Ketorolac, naproxen)
• Obinutuzumab
• omega-3 fatty acids
• Pentoxifylline
• platelet inhibitors (e.g., Ticlopidine, Clopidogrel, Ticagrelor)
• potassium-sparing diuretics (e.g., Amiloride, Spironolactone, triamterene)
• potassium supplements
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• Sulfasalazine
• thrombolytic agents (e.g., alteplase, streptokinase, urokinase)
• tipranavir
• vitamin E
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Fragmin (Dalteparin). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fragmin (Dalteparin).

Bleeding: The most serious risk associated with Fragmin (Dalteparin) is bleeding in any tissue or organ. It is extremely important to have regular blood tests as recommended by your doctor to ensure proper levels of clotting.

If you experience bleeding gums, bleeding from the mouth, bleeding from the anus or vagina, or you notice blood in your urine, contact your doctor as soon as possible. If you have an increased risk of bleeding you should be closely monitored by your doctors while taking Fragmin (Dalteparin).

Blood counts: While you are taking Fragmin (Dalteparin), your doctor will also be monitoring your blood cell counts, including a platelet count. If your platelet level drops very suddenly, you may have to stop Fragmin (Dalteparin) and switch to another type of medication. Make sure to tell your doctor if you have had any problems with low platelets or platelet defects in the past.

Body weight: The safety and effectiveness of Fragmin (Dalteparin) for people of high weight (e.g., over 120 kg) and low weight (e.g., under 46 kg) have not been fully established. If you have a high or low body weight, discuss with your doctor how Fragmin (Dalteparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fragmin (Dalteparin), and whether any special monitoring is needed.

Heart problems: Blood clots have occurred for people with prosthetic heart valves using low molecular weight heparins. People with unstable coronary artery disease may be at increased risk of bleeding. If you have a history of heart disease or have prosthetic heart valves your doctor should closely monitor your condition while you are taking Fragmin (Dalteparin).

Kidney problems: The kidneys remove much of Fragmin (Dalteparin) from your body. People with decreased kidney function or kidney disease may experience increased side effects of Fragmin (Dalteparin) as a result of the medication building up in the body. If you have reduced kidney function or kidney disease, discuss with your doctor how Fragmin (Dalteparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fragmin (Dalteparin), and whether any special monitoring is needed.

Liver problems: People with liver problems may be at an increased risk for bleeding. If you have decreased liver function or liver disease, discuss with your doctor how Fragmin (Dalteparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fragmin (Dalteparin), and whether any special monitoring is needed.

Osteoporosis: Other medications in the heparin family have been reported to encourage the development of osteoporosis. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how Fragmin (Dalteparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fragmin (Dalteparin), and whether any special monitoring is needed.

Potassium levels: Increases in blood levels of potassium occur for a small percentage of people taking medications in the heparin family, including Fragmin (Dalteparin). This may be more likely to happen if you have diabetes or chronic kidney failure, or if you are taking potassium sparing diuretics. Your doctor may want to monitor your potassium levels. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor.

Stomach or intestinal ulcers: Fragmin (Dalteparin) increases the risk of unwanted bleeding. If you have a history of stomach or intestinal ulcers, discuss with your doctor how Fragmin (Dalteparin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fragmin (Dalteparin), and whether any special monitoring is needed. People with active stomach or intestinal ulcers should not use Fragmin (Dalteparin).

Surgery: The risk of bleeding while using low molecular weight heparin may be greater in knee surgery than other orthopedic surgeries. Your doctor will weigh the potential risks and benefits to decide whether low molecular weight heparins will be used during surgery.

There have been cases of spinal bleeding and blood clots when Fragmin (Dalteparin) is used along with spinal or epidural anesthesia. These spinal blood clots may lead to long-term or permanent paralysis. The risk is greater with higher treatment doses of Fragmin (Dalteparin) than with deep vein thrombosis prevention doses. The risk is also greater for people who are taking other medications that affect blood such as Naproxen or Ibuprofen, or other anticoagulants. If you notice a sudden inability to move your body or sudden back pain or tenderness, get medical help immediately.

Pregnancy: Fragmin (Dalteparin) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fragmin (Dalteparin), contact your doctor immediately.

If you do use Fragmin (Dalteparin) while you are pregnant, your doctor should closely monitor you because of an increased risk of bleeding. Pregnant women who have artificial heart valves also need to be closely monitored by their doctors if they use Fragmin (Dalteparin) because of a higher risk of developing clots in their heart valves.

Pregnant women should not use Fragmin (Dalteparin) from multidose vials containing benzyl alcohol as a preservative.

Breast-feeding: It is not known if Fragmin (Dalteparin) passes into breast milk. If you are a breast-feeding mother and are taking Fragmin (Dalteparin), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fragmin (Dalteparin) have not been established for children.

Seniors: Seniors may be at an increased risk of bleeding while using Fragmin (Dalteparin). Your doctor may adjust your dose, especially if you weigh less than 45 kg or have decreased kidney function.

This product thins the blood and prevents blockage of blood vessels. It belongs to the family of low-molecular weight heparins.<br/><br/>It must be injected under the skin (subcutaneously) in the abdominal region, according to the technique you were shown. Be sure to choose a different injection site each time.<br/><br/>WARNING: If you injure yourself, prolonged bleeding may occur. Report any excessive or unusual bleeding to your doctor. To reduce the risk of bleeding, do not consume alcohol, make any significant dietary changes, or take acetylsalicylic acid (ASA, e.g., Aspirin) unless prescribed by your doctor.