2500 IU, 5000 IU, 7500 IU, 10000 IU, 12500 IU, 15000 IU, 18000 IU solution for injection, pre-filled syringe. 2500 IU / ml, 10000 IU / ml solution for injection. 10000 IU / ml, 25000 IU / ml solution for injection (with preservative).
dalteparinnatrium

1. What Fragmin is and what it is used for

Fragmin is an antithrombotic agent (anticoagulant).

Fragmin is used:

  • For the treatment of blood clots in deep veins (blood vessels) and lungs.
  • For the treatment and prevention of blood clots in deep veins (blood vessels) and lungs in cancer patients.
  • Prevention of coagulation in dialysis or blood filtration in renal impairment.
  • Prevention of blood clots during surgical procedures and in case of temporarily reduced mobility due to acute illness such as heart failure or severe infection.
  • Treatment of unstable coronary heart disease.

2. What you need to know before using Fragmin

Do not take Fragmin

Fragmin should not be used if you have or have had any of the following conditions:

  • If you are allergic to dalteparin, heparin, or any of the other ingredients of this medicine (listed in section 6).
  • Thrombocytopenia (decreased number of platelets in the blood). Your doctor has told you if you suffer from this.
  • Gastrointestinal or duodenal ulcer.
  • Cerebral hemorrhage or another active hemorrhage.
  • Increased tendency for bleeding
  • Bacterial infection of the heart ( septic endocarditis ).
  • Injury or surgery in the central nervous system, eyes, or ears.
  • Spinal anesthesia should be avoided during treatment with Fragmin in acute deep vein thrombosis, pulmonary embolism, or unstable coronary heart disease.

Fragmin 10000 IU / ml, solution for injection (with preservative ), and Fragmin 25000 IU / ml, solution for injection (with preservative ) contain benzyl alcohol as a preservative. These should not be given to children under 3 years of age, as benzyl alcohol may cause poisoning or allergic reactions.

Warnings and cautions

You must tell your doctor if you have or have had any of the following conditions as they may affect the effect of Fragmin treatment:

  • Thrombocytopenia and platelet dysfunction.
  • Severe hepatic or renal impairment.
  • Uncontrolled high blood pressure.
  • Changes in the retina of the eye, due to diabetes or high blood pressure.
  • Diabetes
  • Elevated potassium levels
  • Acute myocardial infarction.
  • If you are going to have an operation, you must inform your doctor about this.
  • If you are older. There may be an increased risk of bleeding.
  • If you are allergic or suspect that you are allergic to latex (natural rubber) or if the needle guard on Fragmin pre-filled syringes will be handled by someone with a known or suspected allergy to latex (natural rubber). The needle guard on Fragmin pre-filled syringes may contain latex (natural rubber) which may cause severe allergic reactions in individuals who are allergic to latex (natural rubber).

It is very important that you carefully follow the instructions given to you by your doctor or nurse.

Children

The dosage recommendations for children are based on clinical experience, there are limited data from clinical trials that will help your doctor calculate the dose of Fragmin.

Other medicines and Fragmin

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The treatment effect may be affected if this medicine is taken at the same time as other medicines.

Some medicines that affect blood and coagulation may increase the risk of bleeding during Fragmin treatment, e.g. acetylsalicylic acid and other painkillers and anti-inflammatory drugs called NSAIDs. If you are being treated for unstable coronary heart disease, your doctor may prescribe concomitant treatment with acetylsalicylic acid.

Pregnancy, breastfeeding, and fertility

There are no known risks of using Fragmin during pregnancy.

Fragmin 10000 IU / ml and Fragmin 25000 IU / ml, solution for injection, contains benzyl alcohol as a preservative. Benzyl alcohol may pass through the placenta. Fragmin without preservatives should therefore be used during pregnancy.

Fragmin passes into breast milk.

Therefore consult a doctor before use during breast-feeding.

Data from clinical trials do not indicate that Fragmin affects fertility.

Driving and using machines

Fragmin does not affect the ability to drive. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Fragmin

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by your doctor who adjusts it individually for you.

Fragmin is usually injected by a doctor or nurse. In some cases, you may need to be treated with Fragmin for a longer period after leaving the hospital. In this case, your doctor or nurse will teach you to inject Fragmin yourself before you leave the hospital.

Fragmin should be injected at the same time each day.

Use for children

Dose one will be based on both the child’s age and weight. Younger children may need a little more Fragmin per kg than adults. Your doctor will determine the right dose for you. Healthcare professionals can take blood samples during your treatment to check the effects of Fragmin.

Instructions for use for injecting Fragmin into pre-filled syringes

Fragmin is injected under the skin. You can inject yourself in the abdomen or the thickest part of the upper part of the buttocks. Your doctor or nurse will tell you where it is most suitable for you to inject. In order not to get sore at the injection site, you should vary the injection site.

  1.Before injection, clean the injection site with disinfectant or soap and water. Wipe clean with a towel. On the abdomen, the fat layer can be so thin that you have to lift a fold of skin to be able to inject. You do not have to pinch so hard, but keep a firm grip throughout the injection. If you inject into the buttocks, the fat layer is so thick that you do not need to lift a skin fold.
  2.Remove the entire protective paper on the syringe package. Turn the plastic package over so that you have the syringe in your hand, without pressing the plunger.
  3.Grasp the tip of the colored puncture guard and bend it away from the syringe (see picture below). Remove the gray needle cover by pulling it straight out. The syringe contains a small air bubble that you do not need to take into account. Most of it remains in the top of the syringe and the small amount of air that can get into the adipose tissue is harmless.
 
  4.Lift the skin on the abdomen so that you get a skin fold between the fingers. Then hold the grip throughout the injection. Insert the needle at a 45 ° -90 ° angle in the middle of the skin fold as far as it will go (see picture below).
 
  5.Press the plunger and slowly inject all the Fragmin that is in the syringe. Before pulling out the needle completely, pull it out in half and count to five. Then pull out the entire needle. D o does not rub the skin after injection one.
6. Place the colored needle guard against a hard, stable surface, turn the syringe with one hand upwards so that the needle is forced into the needle guard where it locks in place (see picture below). Then bend the needle further until the syringe exceeds a 45 ° angle to the flat surface.

The syringe can now be taken to a hospital or pharmacy for destruction.

Ask your doctor or nurse if you have any questions.

If you take more Fragmin than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Fragmin

If you forget to take a dose, take it as soon as possible. However, if it is soon time to take the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Tell your doctor if you forget, or think you may have forgotten, to take your dose

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

About 3 out of 100 of the patients treated for prevention are at risk of side effects.

Common (affects more than 1 user in 100) Bruising at the injection site, pain at the injection site. Decreased platelet count ( thrombocytopenia ) which is usually mild and recurs during treatment.BleedingTransient increase in liver enzymes
Uncommon (affects less than 1 user in 100) Hypersensitivity
Rare (affects less than 1 user in 1,000) Local tissue death, transient hair loss
No known frequency (cannot be calculated from the available data) Severe hypersensitivity reaction with symptoms such as itching, rash, swelling ( edema ), and shortness of breathRashBleeding behind the abdominal cavity, in some cases life-threatening bleeding in or around the brain, in some cases life-threatening bleeding in or around the spinal cord

The risk of bleeding is dose-dependent.

Children

The side effects in children are expected to be similar to those in adults, but there is little information on possible side effects with long-term use in children.

5. How to store Fragmin

Keep this medicine out of the sight and reach of children.

Store below 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is dalteparin sodium. 1 ml contains 2,500, 10,000, 12,500 and 25,000 IU anti-Xa, respectively. A pre-filled syringe contains 2,500, 5,000, 7,500, 10,000, 12,500, 15,000 and 18,000 IU anti-Xa, respectively.

– The other ingredients are:

Pre-filled syringe: Water for injections. The pre-filled syringe 2500 IU also contains sodium chloride.

Preservative-free solution for injection: Sodium chloride, water for injections

Liquid for injection with preservative: Benzyl alcohol, water for injections

Do not give to children under 3 years, as benzyl alcohol may cause poisoning or allergic reactions. Other formulations without benzyl alcohol are available.

What the medicine looks like and the contents of the pack

Fragmin is a clear colorless liquid.

Packaging sizes

Pre-filled syringe

2500 IU (0.2 ml at 12500 IU / ml): 2×1, 10×1, 100×1 pcs

5000 IU (0.2 ml at 25000 IU / ml): 2×1, 5×1, 10×1, 25×1, 100×1 pcs

7500 IU (0.3 ml at 25000 IU / ml): 5×1, 10×1 st

10000 IU (0.4 ml at 25000 IU / ml): 2×1, 5×1, 6x5x1 pcs

12500 IU (0.5 ml at 25000 IU / ml): 2×1, 5×1, 6x5x1 pcs

15000 IU (0.6 ml at 25000 IU / ml): 2×1, 5×1, 6x5x1 pcs

18000 IU (0.72 ml at 25000 IU / ml): 2×1, 5×1, 6x5x1 pcs

Solution for injection without preservatives

2500 IU / ml, solution for injection: 10×4 ml vials

10000 IU / mL, injection: 10×1 ml ampoule s

Solution for injection with preservatives

10000 IU / ml solution for injection: 1×10 ml vial

25000 IU / ml solution for injection: 1×4 ml vial

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Phone: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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