FRAGMIN 10 000 IU/4 ML SOLUTION FOR INJECTION

Active substance: DALTEPARIN SODIUM

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T05020

Fragmin® 10,000 IU/1 ml Solution for Injection
and
® 10,000 IU/4 ml Solution for Injection
Fragmin
(dalteparin sodium)

Patient Information Leaflet
This medicine is available under either of the above strengths but will be referred to as Fragmin
throughout the following:
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.
• 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 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 contains the active ingredient dalteparin sodium. It is available in 2 strengths:
10,000 IU/1 ml solution for injection.
10,000 IU/4 ml solution for injection.
Abbreviation: IU = International units
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.
You may be given Fragmin for the following conditions:
• Haemodialysis/Haemofiltration:
Fragmin may be used in patients having haemodialysis or haemofiltration. Fragmin prevents
blood clots being formed in the tubes of the equipment.
Haemodialysis and haemofiltration are methods of removing excessive natural waste
products from the blood of people whose kidneys are no longer able to perform this function.
The 10,000 IU/1 ml can also be used to treat conditions such as venous thromboembolism
and unstable coronary artery disease.
• Venous thromboembolism:
Venous thromboembolism is a condition where blood clots develop in the legs (deep vein
thrombosis) or the lungs (pulmonary embolism). This can happen following surgery,
pregnancy or long periods of bed rest.
• Unstable coronary artery disease:
In patients with coronary artery disease, the coronary arteries (blood vessels to the heart) are
furred up and narrowed by patches of fatty deposits.
Unstable coronary artery disease means that a furred up bit of the artery has ruptured and a
clot has formed on it, reducing the flow of blood to the heart.
Fragmin helps to prevent more clots being formed.
Ask your doctor if you are unsure why you have been given Fragmin.

2. What you need to know before you are given 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 a stomach ulcer or ulcer of the duodenum (small intestine).
• if you have suffered from a brain haemorrhage (bleeding in your brain).
• 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 an injury to, or are about to have an operation involving your spine, head, eyes or
ears.
• if you are suffering from thrombocytopenia (a condition where there are fewer clotting cells
known as platelets in the blood, causing you to bruise and bleed more easily). Your doctor will
have told you if you have this.
If you are receiving Fragmin to treat blood clots, you should not have a local, spinal or epidural
anaesthetic.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you take 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
• 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 artificial heart valves
• if you need any other injections
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
Your doctor will monitor your blood regularly before and during treatment.
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.
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.
Some medicines can affect the way Fragmin works. Fragmin can reduce the effectiveness of
other medicines taken at the same time.
Medicines that increase the effect of Fragmin include;
• Those used to thin your blood (e.g. aspirin, dipyridamole, glycoprotein receptor antagonists
and warfarin)
• 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 blood volume (e.g. dextrans)
• Medicines known as cytostatics (used in cancer treatment)
• Thrombolytic medications for treating transmural heart attack (e.g. TPA-tissue plasminogen
activator).
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 ( e.g. 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
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.

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However, if you have an artificial heart valve and are pregnant, the usual dose of Fragmin might
not be enough to prevent a blood clot. Your doctor will discuss this with you.
If you are receiving Fragmin to treat blood clots, you should not have a local, spinal or epidural
anaesthetic.

• Bleeding at any site
• Certain substances produced by your liver may increase
• Pain and reactions at the site of injection
• Haematoma – collection of blood under the skin

Ask your doctor or pharmacist for advice before taking this medicine whilst breast-feeding.

- Uncommon side effects (may affect up to 1 in 100 people):
• Increased levels of potassium in your blood (symptoms may include temporary muscle
weakness, loss of feeling and changes in your heartbeat)
• Red skin rash and itchiness
• Itching
• Allergic reactions

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 be administered by a doctor or nurse. Fragmin is given either as an injection
into a vein or as 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.
The amount of Fragmin you receive will depend on your particular condition.
• Haemodialysis/Haemofiltration
Use in adults and the elderly:
If you are undergoing haemodialysis or haemofiltration, the medicine will be injected into the
tubes of the haemodialysis machine. For patients with chronic (long term) kidney problems,
who are being given treatment lasting longer than 4 hours, a starting dose of 30-40 IU for
each kg of bodyweight will usually be given. This is followed by an infusion (slow injection) of
10-15 IU/kg every hour. The same dose may be given if the treatment lasts less than 4 hours,
or a single injection of 5000 IU may be given.
For patients with acute (rapid or severe) kidney failure, or patients who are more likely to
bleed, the usual dose is 5-10 IU for each kg of body weight, followed by 4-5 IU/kg every hour.
• Deep Vein Thrombosis
Use in adults and the elderly:
If you are having treatment for deep vein thrombosis you will be given an injection beneath
the skin. The site of this injection will usually be the stomach (abdomen) or outer aspects of
your thigh. A dose of 200 IU for each kg of body weight may be given once a day, or 100 IU/kg
twice a day.
The single daily dose should not exceed 18,000 IU.
Fragmin can be used together with other blood thinning medicines known as Vitamin K
antagonists. Should this be desired, a minimum of five days would be required.
• Unstable Coronary Artery Disease
Use in adults and the elderly:
In the treatment of unstable coronary artery disease, a dose of 120 IU/kg of body weight is
given every 12 hours, as an injection beneath the skin. 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 in a 12 hour period is 10,000 IU.
• Extended use
If your doctor has recommended a special procedure to restore the blood supply to your heart
(angiography or coronary artery surgery), it may be necessary to continue to administer
Fragmin for up to 45 days. In this case, the dose should be either 5,000 IU (women less than
80 kg and men less than 70 kg) or 7,500 IU (women 80 kg and above or men 70 kg and over)
every 12 hours. 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. Medical staff may take blood samples during your treatment to
monitor the effects of Fragmin.
• Children and adolescents
The dose will be based on both the child’s age and weight. Younger children may need
slightly more Fragmin per kg than adults. Your doctor will work out the right dose for you.
Medical staff may take blood samples during your treatment to monitor the effects of Fragmin.
If you are given more Fragmin than you should
If you feel that you have been given more Fragmin than you should, inform your doctor or nursing
staff immediately. Your doctor may want to give you an injection of protamine as an antidote.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Fragmin and talk to a doctor or nurse at once if you get any signs of a severe allergic
reaction (such as difficulty breathing, swelling of the lips, mouth, throat or eyes)
- Common side effects (may affect up to 1 in 10 people):
• A reversible decrease in the number of clotting cells (platelets) in your blood (Type I
thrombocytopenia). This may make you bruise more easily

- Rare side effects (may affect up to 1 in 1,000 people):
• An immune system problem resulting in a severe decrease in the number of clotting cells
(platelets) in your blood (Type II thrombocytopenia)
• Alopecia (hair loss)
• Painful skin lesions
- Not known (frequency cannot be estimated from the available data):
• Bleeding inside or around your brain, symptoms may include sudden severe headache
• Bleeding behind your abdomen (stomach), symptoms may include a feeling of tenderness
and swelling around your stomach
• Bruising of the spine which may lead to back pain, tingling, numbness or weakness in your
legs, bowel or bladder problems
If you have an artificial heart valve, treatment with Fragmin might not be sufficient to prevent a
blood clot, and you might develop a clot in the heart valve.
The adverse reactions in children are expected to be the same as in adults, however there is only
a little information about the possible side effects of long term use in children.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Fragmin
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Fragmin should not be used after the expiry date mentioned on the pack. The expiry date
refers to the last day of that month.
• 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 pack and other information
What Fragmin contains
The active ingredient in Fragmin is dalteparin sodium. They contain the following:
1 ml ampoule: 10000 IU/ml (International unit)
4 ml ampoule: 2500 IU/ml (International unit)
The other ingredients are: sodium chloride, sodium hydroxide or hydrochloric acid and water for
Injection.
What Fragmin looks like and contents of the pack
Fragmin is a clear colourless or straw coloured solution in a glass ampoule.
Fragmin is avialable in packs of 5 and 10.
Manufacturer and Product Licence Holder
This product is manufactured by Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs,
Belgium. It is procured from within the EU by the Product Licence Holder: Swinghope Ltd,
Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Limited, Brandon
House, Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1493
PL No: 10380/1494

Fragmin® 10,000 IU/1 ml Solution for Injection
Fragmin® 10,000 IU/4 ml Solution for Injection

Leaflet revision date: 03/07/2014
Fragmin® is a registered trademark of Pfizer Health AB, 11287, Stockholm, Sweden.

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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.

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