2. What should I know before being treated with FRAGMIN?
Do not start treatment if you have ever had an allergic reaction to dalteparin sodium/heparin/other
medicines derived from heparin, pork products, or any of the ingredients listed at
the end of the CMI; have major bleeding disorders; injury to the brain including stroke;
stomach/bowel problems; bacterial infections in your heart/heart valves; very high
blood pressure; or following injury or operation on your brain, spinal cord, eyes
or ears.
Talk to your doctor if you have: allergy to latex (natural rubber); medical conditions
which involve increased risk of bleeding including stomach ulcers or blood clotting
disorders; high blood pressure; heart infections or an artificial heart valve; diabetes
or eye disease related to diabetes; kidney or liver disease; cancer including brain
tumours; had recent surgical procedures; had metabolic acidosis or high blood potassium;
are being treated for severe pain; take any medicines; or are pregnant, planning to
become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How is FRAGMIN given?
FRAGMIN is given by injection either under the skin, or as a slow 'drip' into a vein.
If you need to use FRAGMIN after you have left hospital, you will be taught to self-inject.
More instructions can be found in Section
4. How is FRAGMIN given? in the full CMI.
5. What should I know during treatment with FRAGMIN?
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Things you should do
|
If you need to have any medical, dental or surgical procedures, tell your doctor,
dentist, anaesthetist or pharmacist that you are/have recently been treated with FRAGMIN
Tell your doctor if you have any unusual bruising or bleeding; back pain, numbness
or weakness in limbs, problems going to the toilet; chest pain or unusual heartbeats
Tell your doctor if you become pregnant while being treated with FRAGMIN
|
|
Things you should not do
|
Do not stop taking this medicine or change the dosage without checking with your doctor.
Do not inject FRAGMIN into a muscle.
|
|
Driving or using machines
|
FRAGMIN does not affect the ability to drive or operate machinery. Be careful driving
or operating machinery until you know if FRAGMIN affects you.
|
|
Looking after your medicine
|
Keep the prefilled syringes in their pack until you are ready to use them in a cool,
dry place where the temperature stays below 25 degrees Celsius (FRAGMIN 10,000 IU)
or below 30 degrees Celsius (FRAGMIN 2,500 IU, 5,000 IU, 12,500 IU, 15,000 IU & 18,000
IU).
|
6. Are there any side effects?
Side effects may include: allergic reaction; pain/bruising/lump at injection site;
hair loss; unusual bleeding including nosebleeds, blood in wee/poo; tingling/numbness
of hands/feet or limbs; slow/irregular heartbeat; dizziness; fever; muscle weakness;
severe headache; bleeding on the brain; osteoporosis; rash, blisters; upset stomach/pain/vomiting;
chest pain; fainting; tiredness.
Active ingredient(s):
Dalteparin sodium
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being treated with FRAGMIN. You should also speak to your doctor or nurse if you would like further information
or if you have any concerns or questions about being treated with FRAGMIN.
Where to find information in this leaflet:
1. Why am I being treated with FRAGMIN?
FRAGMIN belongs to a group of medicines known as low molecular weight heparins (LMWHs).
It contains the active ingredient dalteparin sodium, which is derived from pig intestines.
FRAGMIN is used to treat:
Deep vein thrombosis, "DVT" (a blood clot in a deep vein, usually in the leg or arm)
Blood clots in the veins of the lungs (pulmonary embolism), in certain types of cancer
Unstable heart disease caused by poor blood flow in the blood vessels of the heart
(e.g. angina or heart attack).
FRAGMIN may also be used to prevent:
DVTs before or after an operation
Blood clotting during haemodialysis, a procedure that uses a machine to remove waste
products from the blood in people with kidney failure.
Your doctor may have prescribed it for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
2. What should I know before being treated with FRAGMIN?
Warnings
You should not be given FRAGMIN:
If you have an allergy to dalteparin sodium, heparin or other similar medicines (such
as other LMWHs), pork products, or any of the ingredients listed at the end of this
leaflet.
always check the ingredients to make sure you can be given this medicine.
if you have, or have ever had, any of the following medical conditions: major bleeding
disorders (e.g. haemophilia, severe liver disease); certain types of injury to the
brain including stroke (bleeding in your brain); stomach or bowel problems, such as
ulcers or ulcerative colitis; bacterial infections in your heart or heart valves;
very high blood pressure.
following an injury or operation on your brain, spinal cord, eyes or ears.
If you are being treated with FRAGMIN, you should not:
have a procedure known as 'sympathetic block' (where anaesthesia medicine is injected
to treat specific types of pain).
If you are being treated with high doses of FRAGMIN (eg. for blood clots in the lung
or poor blood flow in the heart), you should not:
have a procedure known as 'regional anaesthesia' (where only a specific area of the
body is numbed, so you can stay awake or sedated while undergoing a procedure or surgery
without losing consciousness).
Check with your doctor if you:
have an allergy to latex (natural rubber). The needle shield on the pre-filled syringe
may contain latex.
have any other medical conditions such as: low platelet count (thrombocytopenia);
high blood pressure; severe problems with blood clotting, bleeding or bruising; infection
or inflammation of the heart valves or have an artificial heart valve; diabetes; eye
disease related to diabetes or high blood pressure; kidney or liver disease, cancer
including brain tumours or thinning of the bones (osteoporosis).
take any medicines for any other condition including other anticoagulant/antiplatelet
medicines or chemotherapy treatment.
have had any recent surgical procedures.
have ever had metabolic acidosis (a serious electrolyte disorder) or high potassium
in your blood.
If your doctor is planning for you to have an anaesthetic injection in your back (spinal
or epidural injection), tell your doctor you are being treated with FRAGMIN.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks. See additional information under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, intend to become pregnant or are breastfeeding.
FRAGMIN is not recommended for use during pregnancy as it may result in adverse outcomes
for the pregnant woman or unborn child. Discuss the risks with your doctor.
FRAGMIN is not recommended for use during breastfeeding. FRAGMIN may pass into breastmilk.
Use in children
It is not recommended that FRAGMIN be given to children.
Use in the elderly
FRAGMIN should be used with caution in the elderly, especially in patients aged 80
years and above, as they may be at an increased risk of bleeding complications, even
when the correct dosages are being used.
3. What if I am taking other medicines?
Tell your doctor or nurse if you are taking any other medicines, including vitamins
or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
Some medicines may interfere with FRAGMIN and affect how it works.
Medicines that may increase the effect of FRAGMIN (i.e. increase the risk of bleeding)
include:
Non-steroidal anti-inflammatory drugs ('NSAIDs') - such as naproxen, ibuprofen, diclofenac,
piroxicam, meloxicam, indometacin and keterolac
Aspirin, however this may be prescribed by your doctor to take with FRAGMIN. Speak
with your doctor before taking aspirin.
Anticoagulants ('blood thinners') - such as warfarin, heparin and other medicines
derived from heparin eg. enoxaparin sodium
Platelet inhibitors - such as clopidogrel, prasugrel, ticagrelor, tirofiban, eptifibatide
and dipyradamole
Thrombolytics (clot-dissolving medicines) - such as alteplase, tenecteplase, apixaban,
rivaroxaban and dabigatran
Dextran, a medicine used to treat shock, which occurs when you have dangerously low
blood pressure
probenecid, a medicine used to treat gout, certain complications associated with HIV,
or used in conjunction with certain antibiotic treatment
medicines used to treat some cancers (known as 'cytostatics' - cytarabine, daunorubicin,
fluorouracil and methotrexate are some examples)
Medicines that may decrease the effect of FRAGMIN (i.e. increase the risk of clotting)
include:
medicines to control bleeding such as andexanet alfa
antihistamines (medicines used to prevent or relieve the symptoms of allergy, hay
fever or rashes) - especially those containing diphenhydramine
digoxin, a medicine used to treat heart failure
tetracycline antibiotics, such as doxycycline, minocycline and tigecycline
medicines or vitamins that contain ascorbic acid (vitamin C).
FRAGMIN may also increase blood potassium levels in patients taking the following
medicines:
potassium salts, some fluid tablets (e.g. amiloride, spironolactone and eplerenone),
some medicines for heart problems (e.g. perindopril, lisinopril, enalapril and telmisartan,
candesartan, irbesartan, losartan) and some antibiotics (e.g. trimethoprim and pentamidine).
If you are taking any of these medicines while using FRAGMIN, your doctor will need
to carefully monitor your blood clotting factors and other blood levels, such as potassium.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect FRAGMIN.
4. How is FRAGMIN given?
How much is given
Your doctor will decide what dose, how often and how long you will receive FRAGMIN.
This depends on your condition and other factors, such as your age, weight, level
of mobility, how well your kidneys are working, and whether other medicines are being
given at the same time.
If you are being treated for deep vein thrombosis (DVT), 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. angina or heart attack),
your doctor might tell you to take aspirin as well.
How it is given
FRAGMIN may be given as an injection either under the skin (subcutaneously) or through
a slow infusion “drip” into a vein (intravenously).
It should not be given as an injection into a muscle (intramuscularly).
FRAGMIN is usually only given by a doctor or nurse. However, 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 the hospital.
How to use FRAGMIN at home
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 should be 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 or alcohol swab, or by washing it with soap and water and patting it
dry with a clean towel.
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, then twist to remove it
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 syringe.
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 FRAGMIN
IF YOU HAVE 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.
IF YOU HAVE 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 are given too much FRAGMIN
If FRAGMIN is being given to you in hospital, it is given under the close supervision
of your doctor, so it is very unlikely that you will receive too much. Your condition
will also be carefully monitored following administration. A symptom of too much FRAGMIN
may be abnormal bleeding.
Tell your doctor or nurse immediately if you are concerned that you may have been
given too much FRAGMIN.
If you are using FRAGMIN at home and you think that you have used too much, you may
need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know during treatment with FRAGMIN?
Things you should do
Use FRAGMIN exactly as your doctor has prescribed.
Remind any doctor, dentist or pharmacist you visit that you are using FRAGMIN.
If you are going to have surgery or undergo any procedures involving anaesthesia medicines
(including spinal or epidural injections), tell your doctor, anaesthetist or dentist
that you are being treated with FRAGMIN.
FRAGMIN may affect other medicines used during those procedures.
Follow your doctor's instructions carefully and be sure to keep all medical appointments.
Your doctor may ask you to have blood tests to check your progress and prevent unwanted
side effects, particularly if you have cancer, liver or kidney disease or are very
thin or very overweight.
Tell your doctor straight away if you:
become pregnant while using FRAGMIN. FRAGMIN is not recommended for use during pregnancy.
experience back pain, numbness or weakness in your lower limbs or have any problems
going to the toilet.
experience any unusual bruising or abnormal bleeding.
have chest pain, fast or irregular heartbeat, or muscle weakness or numbness in your
limbs.
Things you should not do
Do not use FRAGMIN to treat any other complaints unless your doctor tells you to.
Do not give FRAGMIN to anyone else, even if they have the same condition as you.
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.
FRAGMIN is not interchangeable with other low molecular weight heparins (LMWHs), such
as exoxaparin sodium, or other heparin products.
Driving or using machines
Be careful driving or operating machinery until you know if FRAGMIN affects you.
Drinking alcohol
No information is available. If you drink alcohol discuss this with your doctor while
using FRAGMIN.
Looking after your medicine
In the hospital, FRAGMIN will be stored in the pharmacy or on the ward under the correct
conditions.
If using FRAGMIN at home, follow the instructions in the carton on how to take care
of your medicine properly.
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 away from moisture, heat and sunlight, where the
temperature stays below:
30 degrees Celsius for FRAGMIN 2,500 IU, 5,000 IU, 12,500 IU, 15,000 IU and 18,000
IU.
25 degrees Celsius for FRAGMIN 10,000 IU.
Do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Dispose of the used syringe and needle safely in a 'sharps' container or similar puncture
proof container made of hard plastic.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or nurse if you have
any further questions about side effects.
Side effects
Tell your doctor or nurse if you notice anything else that may be making you feel
unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side-effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/safety/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or nurse before you decide to stop taking
any of your medicines.
7. Product details
What FRAGMIN contains
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Active ingredient
(main ingredient)
|
dalteparin sodium
|
|
Other ingredients
(inactive ingredients)
|
water for Injections
2,500 IU & 10,000 IU only:
sodium chloride
|
Do not take this medicine if you are allergic to any of these ingredients.
FRAGMIN does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
What FRAGMIN 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, which is enclosed by a needle
shield.
FRAGMIN is available as 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.
It is also available as graduated single dose syringes:
10,000 IU/1 mL: AUST R 66626.
Who distributes FRAGMIN
Pfizer Australia Pty Ltd
Sydney NSW
® Registered Trademark
This leaflet was prepared in December 2025.