Skip to Content

FRAGMIN GRADUATED SYRINGE 10 000IU/ML SOLUTION FOR INJECTION

Active substance(s): DALTEPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
inks on file

Process structure
Black

Package leaflet: Information for the user

Fragmin®
RECTO

Graduated Syringe 10,000 IU/ml Solution for Injection
dalteparin sodium

PAA058830
104

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 one strength:
10,000 IU (International Units)/1 ml Solution for injection.
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.
• Fragmin may be used to treat a condition known as unstable
angina and non-Q wave myocardial infarction (unstable coronary
artery disease) in patients who are taking aspirin.
• In 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. Patients with this condition may be more
likely to go on to have a heart attack without treatment with blood
thinning drugs such as Fragmin.
Ask your doctor if you are unsure why you have been given Fragmin.

Process Black

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 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 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.

code

PAA058830

guidelines

TSE-I013D

dimensions

210x317/35

date

10-Mar-15 GLA

country

ENGLAND

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.:
o after an operation or trauma
o a stroke caused by a bleed
o severe liver or kidney failure
o abnormal or low numbers of platelets (clotting cells)
o eye disease caused by blood pressure or diabetes
o taking other medicines that thin the blood (e.g. aspirin, warfarin,
dipyridamole)
o 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 any other injections.
You may need to have blood tests to monitor the effects of Fragmin:
o if you have kidney failure or liver problems
o if you are very thin or morbidly obese
o if you are pregnant
o if you are at increased risk of bleeding or rethrombosis (more blood
clots)
o if you are a child.
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, or Fragmin itself
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 the 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 (intravenous nitroglycerine)
• Antibiotics such as high dose penicillin which are used to treat
bacterial infections
• Anti-malarials (e.g. quinine)
• Tobacco smoking.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other low molecular weight heparins or anti-thrombotics.

VERSO

Please note that if you are being treated with Fragmin for unstable
coronary artery disease your doctor may adjust your dose of aspirin
accordingly.
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. 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.
Ask your doctor or pharmacist for advice before taking 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. The
amount of Fragmin you receive will depend on your particular condition.
Fragmin is given as a 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.
Use in adults and the elderly
• Unstable coronary artery disease
The usual dose used to treat unstable coronary artery disease is
120 IU (units) for every kilogram you weigh, given every 12 hours.
Doses are usually given for between 5 and 8 days.
The maximum dose in a 12 hour period is 10,000 IU. 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.

Rare side effects (may affect up to 1 in 1,000 people):
o An immune system problem resulting in a severe decrease in the
number of clotting cells (platelets) in your blood (Type II
thrombocytopenia)
o Alopecia (hair loss)
o Painful skin lesions

- Not known (frequency cannot be estimated from the available data):
o Bleeding inside or around your brain, symptoms may include
sudden severe headache
o Bleeding behind your abdomen (stomach), symptoms may include
a feeling of tenderness and swelling around your stomach
o 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

• 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.

Keep this medicine out of the sight and reach of children.
Fragmin should not be used after the expiry date which is printed on
the label and carton. The expiry date refers to the last day of that
month.
Store below 25°C.
Your doctor or nurse will store Fragmin in a safe place under the above
conditions.

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.

What Fragmin contains
The active ingredient in Fragmin Graduated Syringes is dalteparin
sodium. Each syringe contains 10,000 IU (International units) of
dalteparin sodium as a sterile solution for injection.

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
initiate measures to decrease the risk of bleeding.
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):
o A reversible decrease in the number of clotting cells (platelets) in
your blood (Type I thrombocytopenia). This may make you bruise
more easily
o Bleeding at any site
o Certain substances produced by your liver may increase
o Pain and reactions at the site of injection
o Haematoma – collection of blood under the skin

Process Black

-

Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines that you no longer
use. These measures will help to protect the environment.

6. Contents of the pack and other information

The other ingredients are water for injections, sodium chloride and
either sodium hydroxide or hydrochloric acid (to balance the acidity of
the injection).
What Fragmin looks like and contents of the pack
Fragmin is a clear, colourless or straw-coloured solution in pre-filled
single dose syringes. Each pack contains 5 syringes.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ, UK
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 Puurs
Belgium
This leaflet was last revised in 04/2015
Ref: FR 13_0

- Uncommon side effects (may affect up to 1 in 100 people):
o Increased levels of potassium in your blood (symptoms may
include temporary muscle weakness, loss of feeling and changes
in your heartbeat)
o Red skin rash and itchiness
o Itching
o Allergic reactions
PAA058830

dimensions

210x317/35

country

ENGLAND

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