Fragmin

DRUG DESCRIPTION

FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2500, 5000, 7500, 10,000, 12,500, 15,000 or 18,000 anti-Factor Xa international units (IU), equivalent to 16, 32, 48, 64, 80, 96 or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains either 10,000 or 25,000 anti-Factor Xa IU per 1 mL (equivalent to 64 or 160 mg dalteparin sodium, respectively), for a total of 95,000 anti-Factor Xa IU per vial.

Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative. The pH of both formulations is 5.0 to 7.5. [See Dosage Forms and Strengths and HOW SUPPLIED]

Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process. It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5000 and about 90% of the material within the range 20009000. The molecular weight distribution is:

< 3000 daltons 3.015%
3000 to 8000 daltons 65.078.0%
> 8000 daltons 14.026.0%

What are the possible side effects of dalteparin (Fragmin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; itching or burning skin; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness;
  • any bleeding that will not stop;
  • blood in your urine or stools, black or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • bruising, bleeding, swelling, or skin...

Read All Potential Side Effects and See Pictures of Fragmin

What are the precautions when taking dalteparin (Fragmin)?

Before using dalteparin, tell your doctor or pharmacist if you are allergic to it; or to heparins or pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious active bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: artificial heart valves, bleeding or blood disorders (low platelet counts), certain eye problems (hypertensive or diabetic retinopathy), uncontrolled severe high blood pressure, infection of the heart, kidney...

Read All Potential Precautions of Fragmin


Fragmin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Irritation, bruising, or pain at the injection site may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause bleeding if its effect on your blood clotting proteins is too strong. Tell your doctor immediately if any of these unlikely but serious signs of bleeding occur: unusual pain/swelling/discomfort, unusual or prolonged bleeding, unusual or easy bruising.

Tell your doctor immediately if any of these rare but very serious signs of bleeding occur: dark urine, black stools, severe headache, confusion, vision changes, unusual dizziness, fainting, seizures, weakness, numbness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using dalteparin, tell your doctor or pharmacist if you are allergic to it; or to heparins or pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: serious active bleeding.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: artificial heart valves, bleeding or blood disorders (low platelet counts), certain eye problems (hypertensive or diabetic retinopathy), uncontrolled severe high blood pressure, infection of the heart, kidney disease, liver disease, low platelet counts after previous heparin treatment, certain stomach/intestinal problems (e.g., active or recent ulcers), stroke, recent spinal procedures or puncture, spine problems (such as spinal deformity), recent eye/brain/spinal cord surgery.

Limit alcohol while taking this drug because it may increase the risk of stomach bleeding.

Before having surgery, tell your doctor or dentist that you are using dalteparin.

This medication can infrequently cause heavy bleeding. Be extra careful to avoid injuries (e.g., contact sports). Use an electric razor when shaving and a soft toothbrush when brushing your teeth.

The elderly may be at greater risk for bleeding while using this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Pregnant women with artificial heart valves need close monitoring (see Notes).

It is unknown if this medication passes into breast milk. Consult with your doctor before breast-feeding.


Fragmin Patient Information Including Side Effects

Brand Names: Fragmin

Generic Name: dalteparin (Pronunciation: DAL te PAR in)

  • What is dalteparin (Fragmin)?
  • What are the possible side effects of dalteparin (Fragmin)?
  • What is the most important information I should know about dalteparin (Fragmin)?
  • What should I discuss with my healthcare provider before receiving dalteparin (Fragmin)?
  • How should I use dalteparin (Fragmin)?
  • What happens if I miss a dose (Fragmin)?
  • What happens if I overdose (Fragmin)?
  • What should I avoid while using dalteparin (Fragmin)?
  • What other drugs will affect dalteparin (Fragmin)?
  • Where can I get more information?

What is dalteparin (Fragmin)?

Dalteparin is an anticoagulant (blood thinner) that prevents the formation of blood clots.

Dalteparin is used to treat or prevent blood clots in the veins, arteries, or lung that can be caused by cancer or certain heart conditions. Dalteparin is also used before surgery to reduce the risk of blood clots.

Dalteparin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dalteparin (Fragmin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; itching or burning skin; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • easy bruising or bleeding, unusual weakness;
  • any bleeding that will not stop;
  • blood in your urine or stools, black or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • bruising, bleeding, swelling, or skin changes where the medicine was injected;
  • nausea, sweating, feeling light-headed, fainting;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in one or both legs; or
  • trouble breathing.

Less serious side effects include mild pain, redness, or warmth where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dalteparin (Fragmin)?

You should not receive this medication if you are allergic to dalteparin or pork products, or if you have uncontrolled bleeding, a severe lack of platelets in your blood, or if you are having surgery with spinal or epidural anesthesia.

Before you receive dalteparin, tell your doctor if you have eye problems caused by diabetes or high blood pressure, an infection of your heart, uncontrolled high blood pressure, a bleeding or blood clotting disorder, stomach or intestinal bleeding, liver disease, or if you have ever had a blood cell problem caused by heparin.

Avoid taking aspirin while you are receiving dalteparin, unless your doctor recommends it as part of your treatment. Aspirin can increase your risk of bleeding.

Tell your doctor about all the prescription and over-the-counter medications you use, especially blood thinners, aspirin, NSAIDs (such as Advil, Motrin Aleve, Orudis), or other medications used to treat or prevent blood clots. Do not start using a new medication without telling your doctor.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using dalteparin. You may need to stop using the medicine for a short time.

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