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Introduction About FRAGMIN 2500IU INJECTION

FRAGMIN 2500IU INJECTION contains Dalteparin which belongs to a group of medicines called Anticoagulants. It is used to manage venous thromboembolism (blood clots) and its recurrence, deep vein thrombosis in bedridden patients and blood clot formation in the tubes of the equipment, in patients having haemodialysis or hemofiltration.

Venous thromboembolism is a condition where blood clots form in the legs (deep vein thrombosis causing swelling, redness, pain) or the lungs (pulmonary embolism causing sudden chest pain, increased heart rate and shortness of breath).

FRAGMIN 2500IU INJECTION is also used to manage solid tumours in patients with low platelet count and unstable coronary artery disease (reduced blood flow to the heart due to a clot formed on ruptured part of artery).

Along with this management, your doctor might ask you to make certain lifestyle changes such as quitting smoking. Your doctor may want you to take several blood tests to monitor the effects of FRAGMIN 2500IU INJECTION.

FRAGMIN 2500IU INJECTION is not recommended for use in stomach or intestinal ulcer, brain hemorrhage, septic endocarditis or heparin-induced thrombocytopenia. Before receiving FRAGMIN 2500IU INJECTION, inform your doctor if you have conditions which make you more susceptible to bleeding (Ex. hemophilia, severe kidney or liver failure etc.).

FRAGMIN 2500IU INJECTION should be used with caution among pregnant or breastfeeding women. Your doctor will prescribe the right dose of FRAGMIN 2500IU INJECTION for your child depending on their age, body weight and disease condition.

The most common side effects of receiving FRAGMIN 2500IU INJECTION are decrease in the number of platelets (causing easy bruising), bleeding at any site, pain and reactions at the site of injection and hematoma (collection of blood under the skin). Call your doctor if any of the symptoms worsen.

Uses Of FRAGMIN 2500IU INJECTION

Used to:

Prevent venous thromboembolism and its recurrence
Prevent deep vein thrombosis in bedridden patients
Prevent blood clot formation in the tubes of the equipment, in patients having haemodialysis or hemofiltration
Manage solid tumours in patients with low platelet count
Manage unstable coronary artery disease

How FRAGMIN 2500IU INJECTION Works

FRAGMIN 2500IU INJECTION acts by increasing the activity of a plasma protein (antithrombin III) that inhibits formation of certain clotting factors and thus, manages formation of blood clots.

How to use FRAGMIN 2500IU INJECTION

FRAGMIN 2500IU INJECTION will be given to you only by a doctor or a nurse under your skin as a subcutaneous injection. Your doctor will decide the correct dose and duration of management for you depending upon your age, body weight and disease condition.

Side Effects Of FRAGMIN 2500IU INJECTION

Common

a reversible decrease in the number of platelets in blood (which increases bruising tendency)
bleeding at any site
certain substances produced by the liver may increase
pain and reactions at injection site
hematoma (blood collection under the skin)

Uncommon

temporary muscle weakness, loss of feeling and changes in your heartbeat (due to increased levels of potassium in the blood)
red skin rash and itchiness
allergic reactions
osteoporosis (bones may weaken and break more easily)

Rare

an immune system problem resulting in a severe decrease in the number of platelets in the blood
alopecia (hair loss)
painful skin lesions

Stop receiving FRAGMIN 2500IU INJECTION and contact your doctor immediately if you experience any of the following side effects:

severe allergic reaction (difficulty in breathing, swelling of the lips, mouth, throat or eyes)

Warning & Precautions

Pregnancy

FRAGMIN 2500IU INJECTION is not recommended to manage blood clots on artificial valves during pregnancy. FRAGMIN 2500IU INJECTION should be used with caution otherwise. Consult your doctor for advice.

Breastfeeding

FRAGMIN 2500IU INJECTION should be used with caution in breastfeeding women. Consult your doctor for advice.

Driving and Using Machines

FRAGMIN 2500IU INJECTION does not affect the ability to drive and operate machinery.

Kidney

FRAGMIN 2500IU INJECTION should be used with caution in patients with severe kidney failure. Consult your doctor for advice.

Liver

FRAGMIN 2500IU INJECTION should be used with caution in patients with severe liver failure. Consult your doctor for advice.

Allergy

Do not receive FRAGMIN 2500IU INJECTION if you are allergic to Dalteparin or any of the other ingredients of this medicine.

Heart Disease

FRAGMIN 2500IU INJECTION is not recommended for use in patients with septic endocarditis (infection and inflammation of the lining of the heart and heart valves).

FRAGMIN 2500IU INJECTION should be used with caution in patients with uncontrolled high blood pressure or in those who had on operation to insert an artificial heart valve. Consult your doctor for advice.

Others

FRAGMIN 2500IU INJECTION is not recommended for use if you:

have an active stomach or small intestinal ulcer
have suffered from a brain hemorrhage (bleeding in your brain)
have fluid mixed with blood which appears around the heart and lungs
have a condition which may cause you to bleed more easily (Ex. hemophilia, liver failure)
have heparin-induced thrombocytopenia (a decrease in the number of platelets in your blood caused by heparin, which may cause you to bruise and bleed more easily)
have an injury or operation involving your spine, head, eyes or ears
had stroke in past three months

Before receiving FRAGMIN 2500IU INJECTION, inform your doctor if you:

have eye disease caused by blood pressure or diabetes
are allergic or suspect you have a possible allergy to latex (rubber)
have too much potassium in your blood or have a low blood pH
just had an operation or trauma
have a brain tumor
have low blood platelet count
smoke tobacco

Use in Pediatrics:

Your doctor will prescribe the right dose of FRAGMIN 2500IU INJECTION for your child depending on their age, body weight and disease condition.

Use in Geriatrics:

FRAGMIN 2500IU INJECTION should be used with caution in elderly patients (65 years or older). Consult your doctor for advice.

Interactions

A. Drug - Drug interactions:

Before receiving FRAGMIN 2500IU INJECTION, inform your doctor if you are taking any of the following medicines:

medicines used to thin your blood (Ex. aspirin, dipyridamole, tirofiban, warfarin)
medicines used for pain and inflammation relief (Ex. indomethacin, celecoxib)
medicines used for gout (Ex. sulfinpyrazone, probenecid)
etacrynic acid (used for water retention)
solutions given to increase blood volume (Ex. dextrans)
medicines used in cancer management (Ex. paclitaxel, doxorubicin)
medicines used to dissolve blood clots (Ex. alteplase, reteplase)
medicines used for allergy and hay fever (Ex. cetirizine, loratadine)
medicines used for heart or circulation problems (Ex. digoxin, digitoxin)
medicines used to manage bacterial infections (Ex. tetracycline, minocycline, penicillin)
vitamin C (used as a supplement)
medicines used to manage angina (Ex. nitroglycerine, isosorbide dinitrate)
medicines used for malaria (Ex. quinine, artesunate)

Overdosage:

FRAGMIN 2500IU INJECTION will be administered to you by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, see your doctor or nurse if you experience any unusual symptoms.

Synopsis

Drug	:	Dalteparin
Pharmacological Category	:	Low molecular weight heparin
Therapeutic Indication	:	Venous thromboembolism, Solid tumors with low platelets
Dosage Forms	:	Injection, Prefilled syringe

More Information

Keep FRAGMIN 2500IU INJECTION out of reach of children
Store below 25°C

FAQs About FRAGMIN 2500IU INJECTION

Can FRAGMIN 2500IU INJECTION be used in pregnant women?

FRAGMIN 2500IU INJECTION is not recommended to manage blood clots on artificial valves during pregnancy. It should be used with caution otherwise. If you are pregnant, think you may be pregnant or are planning for a child, consult your doctor before receiving it.

Can FRAGMIN 2500IU INJECTION be used for cancer management?

Yes. FRAGMIN 2500IU INJECTION can be used for patients with cancer related thrombosis (blood clot) and its prevention. But your doctor will check if you weigh more than 40kg to proceed with the management. Consult your doctor for advice.

Can the action of FRAGMIN 2500IU INJECTION be reversed?

No, there is no complete reversal of the anti-clotting action of FRAGMIN 2500IU INJECTION but can be partially reversed with the help of vitamin K. Consult your doctor for further queries.

What should I do if I forget to receive a dose of FRAGMIN 2500IU INJECTION?

Please stick to the prescribed schedule as agreed with your doctor for optimal efficacy of FRAGMIN 2500IU INJECTION management. Tell your doctor whenever you forget to receive any dose.

Can I stop receiving FRAGMIN 2500IU INJECTION if I feel better?

Continue receiving FRAGMIN 2500IU INJECTION until your doctor tells you to stop, unless you experience any unwanted effects, worsening of your condition or any new symptoms. Call your doctor in such case.

References

1. KD. Tripathi. Drugs Affecting Blood and Blood Formation. Essentials of Medical Pharmacology. Eighth edition. 2019. Page – 666.

2. Alain Leizorovicz, Alexander T. Cohen, Alexander G.G. Turpie, Carl-Gustav Olsson, Paul T. Vaitkus, Samuel Z. Goldhaber. Radomized, Placebo-controlled trial of Dalteparin for the Prevention of Venous Thromboembolism in acutely Ill Medical Patients. Circulation. AHA Journals. August 2004. [Accessed on 12th December 2022]. https://www.ahajournals.org/doi/10.1161/01.cir.0000138928.83266.24

3. University of Rochester. A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS). NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in November 2015] [Accessed on 12th December 2022]. https://clinicaltrials.gov/ct2/show/NCT00876915

4. Pfizer Manufacturing Belgium NV. Electronic Medicines Compendium (EMC). [Revised in October 2020] [Accessed on 12th December 2022]. https://www.medicines.org.uk/emc/files/pil.4246.pdf, https://www.medicines.org.uk/emc/files/pil.4248.pdf

5. Pfizer Manufacturing Belgium NV. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 12th December 2022]. https://www.medicines.org.uk/emc/files/pil.4251.pdf

6. Pfizer Labs. Fragmin (Dalteparin). [Revised in August 2022] [Accessed on 12th December 2022]. https://labeling.pfizer.com/ShowLabeling.aspx?id=2293#S1.1

Useful Diagnostic Tests

Blood tests
D-dimer testing
Computed tomographic pulmonary angiography (CTPA)
Ventilation-perfusion scan
Magnetic resonance imaging (MRI)

Author Details

Written By Dr. Jeenal Rajani - Pharm.D.

Reviewed For Accuracy By Dr. Thamada Manikanta Praveen - MBBS, MD (General Medicine)

Last updated on 13 Dec 2022 | 12:23 PM(IST)