Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about FRAGMIN.
It does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
FRAGMIN against the expected benefits it will have for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again later.
What FRAGMIN is used for
FRAGMIN is used to prevent blood clots forming in blood vessels. It is used in the
treatment of deep vein thrombosis (also known as DVT, a blood clot in the veins of
treatment of DVT and pulmonary embolism (blood clot in the veins of the lungs) for
up to 6 months in patients with certain types of cancers
prevention of DVT before and after an operation
treatment of unstable heart disease (e.g. angina and heart attack), which is caused
by poor blood flow in the blood vessels of the heart.
FRAGMIN is also used to prevent blood clotting during haemodialysis, a procedure that
uses a machine to remove waste products from the blood in people with kidney failure.
FRAGMIN belongs to a group of medicines called low molecular weight heparins (LMWHs).
These medicines work by reducing blood clotting activity.
Ask your doctor if you have any questions about why FRAGMIN has been prescribed for
Your doctor may have prescribed FRAGMIN for another reason.
Before you use FRAGMIN
When you must not use it
Do not use FRAGMIN if you have an allergy to:
any medicine containing dalteparin sodium
any other low molecular weight heparin or similar medicines such as heparin
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of allergy include skin rash, itching, difficulty breathing,
and swelling of the face.
Do not use FRAGMIN if you have or ever had any of the following medical conditions:
low platelet count caused by heparin
stomach or bowel problems such as ulcers or ulcerative colitis
a certain type of stroke caused by bleeding in the brain
uncontrolled high blood pressure
severe problems with blood clotting
infection and inflammation of the heart valves.
Do not use FRAGMIN:
following an injury or operation on your brain, spinal cord, eyes or ears
if you are being treated for deep vein thrombosis (a blood clot in the veins of the
leg), pulmonary embolism (blood clot that has travelled to the lungs) or unstable
heart disease (e.g. angina and heart attack), and you are going to have surgery that
requires a local anaesthetic
if you will be given an anaesthetic injection in your back (spinal or epidural injection).
Do not use FRAGMIN after the expiry date printed on the pack.
Do not use FRAGMIN if the packaging is torn or shows signs of tampering.
If the product has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start treatment with FRAGMIN, talk to your
doctor or pharmacist.
FRAGMIN is not recommended for use in children, as its safety and effectiveness have
not been established in children.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives,
Tell your doctor if you have or have had any of the following:
eye disease related to diabetes or high blood pressure
kidney or liver disease
thinning of the bones (osteoporosis)
problems with bleeding or bruising
an artificial heart valve.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
FRAGMIN is not recommended for use during pregnancy or breastfeeding. Your doctor
can discuss with you the risks and benefits involved.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start treatment with FRAGMIN.
Taking other medicines
Tell your doctor or pharmacist if you are taking other medicines, including any that
you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may alter the effects of FRAGMIN. These include:
medicines or substances used to prevent or treat blood clots
Dextran, a medicine used to treat shock, which occurs when you have dangerously low
aspirin and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to relieve
pain, swelling and other symptoms of inflammation, including arthritis
probenecid, a medicine used to treat gout
medicines used to treat some cancers
ethacrynic acid, a medicine used to help the kidneys get rid of salt and water by
increasing the amount of urine produced
antihistamines, medicines used to prevent or relieve the symptoms of allergy, hay
fever or rashes
digoxin, a medicine used to treat heart failure
tetracycline, an antibiotic used to treat some infections
medicines that contain ascorbic acid (vitamin C).
If you are taking any of these medicines while using FRAGMIN, your doctor will need
to carefully monitor your blood clotting factors.
These medicines may be affected by FRAGMIN or may affect how well it works. You may
need to use different amounts of your medicine or you may need to use different medicines.
Your doctor or pharmacist will advise you.
Your doctor or pharmacist has a complete list of medicines to be careful with or avoid
while using FRAGMIN.
How it is given
FRAGMIN is given by injection, either under the skin (subcutaneously) or into a vein
(intravenously). The dose and length of treatment will depend on your condition. Your
doctor or nurse will usually give you your injection.
If you are being treated for deep vein thrombosis, your doctor may tell you to start
taking another oral medicine to prevent blood clots, such as warfarin tablets.
If you are being treated for unstable heart disease, e.g. unstable angina or heart
attack, your doctor might tell you to take aspirin as well.
Using it at home
In certain conditions you might have to use FRAGMIN after you have left hospital.
In that case, your doctor or nurse will teach you how to self-inject before you leave
To inject FRAGMIN, you should be sitting or lying down. Do not expel the air bubble
from the syringe before injection. This should ensure delivery of the full dose.
The injection is given under the skin. You can inject yourself in either your stomach
or the fleshiest part of your upper buttock.
Your doctor or nurse will tell you which of these two areas is better for you to use.
Whichever area you use, try to make sure that you inject yourself in slightly different
spots each time to avoid soreness at the injection site.
Before you inject, make sure that the injection site is clean by wiping the area with
an antiseptic swab, or by washing it with soap and water and patting it dry with a
If you are injecting yourself in the stomach, you will need to lift up a fold of skin
to make a slight bulge, as the layer of fat may be quite thin. Keep a firm grip of
the skin throughout the whole injection without pinching yourself too tightly.
If you are injecting yourself in the buttock, there is no need to lift a fold of skin,
as the layer of fat is thick enough.
Hold the base of the rubber cover that protects the needle, twist to remove from the
needle. Insert the needle into the skin vertically, as far as it will go. Press on
the plunger and withdraw the needle when you have injected the whole content of the
Dispose of the used syringe and needle in a safe manner. If you have any questions,
ask your doctor or nurse for help.
If you forget to use it
TWICE DAILY INJECTIONS
If it is less than 6 hours since you should have injected, give yourself an injection
and then continue as usual. If more than 6 hours has passed, give yourself the next
injection when it is time to do so.
ONCE DAILY INJECTIONS
If it is less than 12 hours since you should have injected, give yourself an injection
as soon as you can and then continue as usual. If more than 12 hours have passed,
give yourself the next injection when it is time to do so.
In either case, contact your doctor if you are concerned or have any questions.
If you use too much (overdose)
Immediately telephone the Poisons Information Centre (telephone 13 11 26) or go to
the Accident and Emergency department at your nearest hospital if you think that you
or anyone else may have used too much FRAGMIN.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Keep telephone numbers of these facilities handy.
While you are using FRAGMIN
Things you must do
Use FRAGMIN exactly as your doctor has prescribed.
If you are about to be started on any new medicine, remind your doctor, dentist and
pharmacist that you are using FRAGMIN.
If you are going to have surgery, tell your doctor, anaesthetist or dentist that you
are being treated with this medicine.
Tell your doctor that you are using FRAGMIN if you are going to have a local anaesthetic
or an anaesthetic injection in your back (spinal or epidural injection).
If you become pregnant while using FRAGMIN, tell your doctor immediately.
Things you must not do
Do not give FRAGMIN to anyone else, even if they have the same condition as you.
Do not use FRAGMIN to treat any other complaints unless your doctor tells you to.
Do not stop using your medicine or change the dosage without checking with your doctor.
Do not mix FRAGMIN with other injections or infusion solutions.
Do not inject FRAGMIN into a muscle.
Things to be careful of
FRAGMIN is not interchangeable with other low molecular weight heparins (LMWHs) or
Follow your doctor's instructions carefully and be sure to keep all medical appointments.
Your doctor may ask you to have blood tests to prevent unwanted side effects.
Tell your doctor, pharmacist or nurse as soon as possible if you do not feel well
during or after treatment with FRAGMIN.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Ask your doctor, nurse or pharmacist to answer any questions that you may have.
Tell your doctor or pharmacist if you notice any of the following side effects:
pain and bruising at the injection site
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
low blood platelet count, which you may notice as unusual bleeding or bruising such
as blood in the urine or bowel motions, black tarry bowel motions or black vomit
symptoms of high potassium level in the blood, such as, nausea, fatigue, muscle weakness,
tingling or numbness of the hands or feet, a slow or irregular heartbeat.
allergic reactions, including rash, hives, itching, blisters, skin necrosis (black-purple
skin), low blood pressure (dizziness or light-headedness) and fever
back pain, tingling, numbness or weakness in your legs, which could mean bleeding
around your spinal cord.
The above list includes rare but very serious side effects. You may need urgent medical
attention or hospitalisation.
Tell your doctor, nurse or pharmacist immediately if you notice anything that is making
you feel unwell during or after treatment with FRAGMIN.
Other side effects not listed above may also occur in some patients. Some of these
side effects can be found only when your doctor does tests from time to time to check
your progress. (e.g. changes in liver function shown in blood tests, increased blood
After using FRAGMIN
Keep the syringes in the pack until it is time to use them.
If you take the syringes out of the pack they may not keep well.
Keep FRAGMIN in a cool dry place where the temperature stays below:
30 degrees Celsius for FRAGMIN 2,500 IU and 5,000 IU
25 degrees Celsius for the other FRAGMIN products.
The recommended storage conditions for your product are shown on the carton.
Do not store FRAGMIN or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Discard any unused solution.
A solution for infusion should be used within 12 hours of its preparation.
Keep FRAGMIN where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Dispose of the used syringe and needle safely in a 'sharps' container or similar puncture
proof container made of hard plastic.
If your doctor tells you to stop using FRAGMIN or you find that the syringes have
passed their expiry date, ask your doctor or pharmacist what to do with any that are
What it looks like
FRAGMIN is a clear, colourless or straw-coloured solution. The solution is contained
in a pre-filled glass syringe. A non-removable needle is attached to each syringe.
FRAGMIN comes in five sizes of single fixed dose syringes and two sizes of graduated
single dose syringes. The 7,500 IU and 10,000 IU graduated syringes have measurement
markings to allow the dose to be adjusted.
FRAGMIN contains dalteparin sodium as the active ingredient. FRAGMIN also contains
water for injections and sodium chloride (only 2500 IU, 7,500 IU and 10,000 IU).
FRAGMIN is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free number: 1800 675 229
Australian registration numbers
Fixed single dose syringes
2,500 IU/0.2 mL: AUST R 25347
5,000 IU/0.2 mL: AUST R 25349
12,500 IU/0.5 mL: AUST R 61939
15,000 IU/0.6 mL: AUST R 61938
18,000 IU/0.72 mL: AUST R 61937.
Graduated single dose syringes
7,500 IU/0.75 mL: AUST R 66625
10,000 IU/1 mL: AUST R 66626.
This leaflet was revised on 17 August 2015
® Registered trademark
© Pfizer Australia Pty Ltd 2015