FRAGMIN 2500 IU/0.2ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER



FRAGMIN® 2500IU/0.2ML SOLUTION FOR INJECTION
(dalteparin sodium)







This product is available as the above but will be referred to as Fragmin
throughout the remainder of this leaflet.
This product is available in 5000IU.
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. If your doctor has given
you this medicine to use at home do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
 If you get any side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Fragmin is and what it is used for
2. What you need to know before you are given or use Fragmin
3. How Fragmin is given to you
4. Possible side effects
5. How to store Fragmin
6. Contents of the pack and other information
1.

What Fragmin is and what it is used for

Fragmin is a solution for injection. Its active ingredient is dalteparin
sodium.
Fragmin belongs to a group of medicines called low molecular weight
heparins or antithrombotics, which help prevent the formation of blood clots
by thinning the blood.
Venous thromboembolism is a condition where blood clots develop in the legs
(deep vein thrombosis) or the lungs (pulmonary embolism), e.g. after surgery,
prolonged bed rest or in patients with certain types of cancer.


Fragmin is used to prevent blood clots (venous thromboembolism)
forming before and after an operation or if you are bedridden due to
illness and to prevent their recurrence.

The 5000 IU product can also be used for:
 Prevention of deep vein thrombosis in patients bedridden due to a
medical condition but not limited to, for example heart failure and
respiratory failure.
 Treatment of patients with solid tumours who suffer from low platelet
counts.
Ask your doctor if you are unsure why you have been given Fragmin.
2.

What you need to know before you are given or use Fragmin

You should not be given Fragmin:
 if you are allergic (hypersensitive) to the active ingredient dalteparin
sodium or a similar product or any of the other ingredients of this
medicine (listed in section 6).
 if you have an active stomach ulcer or ulcer of the duodenum (small
intestine).
 if you have suffered from a brain haemorrhage (bleeding in your brain)
 if you have fluid mixed with blood that appears around heart and lungs.
 if you suffer from any condition which may cause you to bleed more
easily (e.g. haemophilia, liver failure). Ask your doctor if you are unsure.
 if you have a condition called septic endocarditis (an infection and
inflammation of the lining of the heart and heart valves). Your doctor will
have told you if you have this.
 if you have had a condition called “heparin-induced
thrombocytopenia” (a decrease in the number of clotting cells (platelets)
in your blood caused by heparin, which may cause you to bruise and
bleed more easily). Your doctor will have told you if you have this.
 if you have an injury to, or have had an operation involving your spine,
head, eyes or ears.
If you are receiving Fragmin to treat blood clots, you should not have a local,
spinal or epidural anaesthetic.

Medicines that can reduce the effect of Fragmin include:
 Those for allergy and hay fever (e.g. antihistamines).
 Those used for heart or circulation problems (e.g. digoxin or digitoxin).
 Antibiotics known as tetracyclines which are used to treat bacterial
infections.
 Vitamin C (e.g. some vitamin supplements).
Other medicines that may interfere with Fragmin include:
 Those used to treat angina (intravenous nitroglycerine)
 Antibiotics such as high dose penicillin which are used to treat bacterial
infections
 Anti-malarials (e.g. quinine)
 Tobacco smoking.
Please note that if you are being treated with Fragmin for unstable coronary
artery disease your doctor may adjust your dose of aspirin accordingly.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other low molecular weight heparins or anti-thrombotics.
Pregnancy and breast-feeding
Fragmin has not been found to cause harmful effects during pregnancy. The
possibility of harm to the baby appears remote. Tell your doctor if you are
pregnant and they will advise you.
Fragmin is not recommended for the prevention of blood clots on artificial
heart valves during pregnancy.
If you are receiving Fragmin to treat blood clots, you should not have a local,
spinal or epidural anaesthetic.
Ask your doctor or pharmacist for advice before being given or using this
medicine whilst breast-feeding.
Driving and using machines
Fragmin does not affect the ability to drive and operate machinery.
3.

How Fragmin is given to you

Your medicine will usually be administered by a doctor or nurse or you may
be shown how to give the injection yourself at home (See Section on How to
Inject Fragmin). The amount of Fragmin you receive will depend on your body
weight.
Fragmin is given as a single, once daily, subcutaneous injection, which
means it is injected beneath the skin. It is usually injected into a skin fold in
your abdomen (stomach), or the outer aspects of your thigh. It should not be
injected into your muscles.
Use in adults and the elderly
To prevent blood clots (venous thromboprophylaxis)
 Patients with a moderate risk of developing a clot:
The recommended dose is 2,500 IU one to two hours before the
operation, then 2,500 IU each morning. This is continued for five to seven
days, or until you are fully able to move about.


Patients with a greater risk of developing a clot e.g. those who have
had clots in the past:
For this type of patient, the recommended dose is 2,500 IU one to two
hours before the operation, the same dose 8 to 12 hours later, then 5,000
IU each morning. As an alternative, 5,000 IU may be given the evening
before the operation, then 5,000 IU on following evenings. The first dose
(2,500 IU) may also be given as soon as possible after your operation
and is to be continued for five to seven days, or until you are able to move
about.



Hip Replacement Surgery
After a hip operation, your doctor may decide to continue treating you
with Fragmin for five weeks using a dose of 5,000 IU every evening. If
you have an artificial heart valve, the normal dose for prevention of blood
clots is not sufficient. Your doctor will discuss this with you.
The maximum dose you will be given in a 12 hour period is 10,000 IU.
If you are bedridden due to illness, the dose of Fragmin given will be
5,000 IU daily. The length of treatment will be up to 14 days, depending
on your illness.

If you are given this medicine as part of your cancer treatment your doctor will
check that you weigh more than 40 kg, and that you have not had a stroke
within the last 3 months.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given or use Fragmin:
 if you have conditions which make you more susceptible to bleeding e.g.:

after an operation or trauma

a stroke caused by a bleed

a brain tumour

severe liver or kidney failure

abnormal or low numbers of platelets (clotting cells)

eye disease caused by blood pressure or diabetes

taking other medicines that thin the blood (e.g. aspirin, warfarin,
dipyridamole)

uncontrolled high blood pressure.
 if you have been told by your doctor that you have a lot of potassium in
your blood or have a low blood pH. Your doctor will monitor your blood
regularly before and during treatment.
 if you have ever had an operation to insert an artificial heart valve.
 if you need to have any other injections.

Medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to
reduce pain and inflammation (e.g. indometacin).
Some medicines for gout (e.g. sulfinpyrazone and probenecid).
Etacrynic acid (a water retention tablet (diuretic)).
Solutions given to increase the blood volume (e.g. dextrans).
Medicines known as cytostatics (used in cancer treatment).
Thrombolytic medications for treating transmural heart attack (e.g. TPAtissue plasminogen activator).




These are typical doses for adults, including elderly patients. Your doctor
will work out the right dose for you. Some of the liquid in the syringe may
have to be expelled before the injection is given.
To treat blood clots (venous thromboembolism) in certain types of
cancer and prevent recurrence
The usual dose used to treat venous thromboembolism in cancer is 200 IU
(international units) for every kilogram you weigh (see table below) once daily
during the first month after a thromboembolic event (blood clot),
followed by 150 IU for every kilogram you weigh (during months 2-6).
Dose of Fragmin during month 1

Children and adolescents
Dosing recommendations in children are based on clinical experience; there
are limited data from clinical trials, which will help your doctor calculate the
dose of Fragmin.

Body weight (kg)

Dose (IU)

< 46

7,500

46-56

10,000

57-68

12,500

69-82

15,000

≥ 83

You may need to have blood tests to monitor the effects of Fragmin:

if you have kidney failure or liver problems

if you are very thin or morbidly obese

if you are pregnant

if you are at increased risk of bleeding or rethrombosis (more blood
clots)

if you are a child

if you have blood problems due to cancer treatment.

18,000

Dose of Fragmin during months 2-6
Body weight (kg)

Dose (IU)

Other medicines and Fragmin
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
are planning to take or use any other medicines. This includes medicines that
you have bought for yourself.

< 56

7,500

56 to 68

10,000

69 to 82

12,500

Some medicines can affect the way Fragmin works, or Fragmin itself can
reduce the effectiveness of other medicines taken at the same time.

83 to 98

15,000

≥99

18,000

Medicines that increase the effect of Fragmin include:
 Those used to thin your blood (e.g. aspirin, dipyridamole, glycoprotein
receptor antagonists and warfarin).

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)