Paracetamol
Consumer Medicine Information
What Perfalgan is used for
Perfalgan contains paracetamol an analgesic medicine which relives pain and reduces fever. Perfalgan is a solution of paracetamol which is given by intravenous infusion (IV) directly into a vein, and is used to relieve pain or reduce fever following surgery.
This medicine is available only with a doctor's prescription.
Before you are given Perfalgan
When you must not be given Perfalgan
You must not be given Perfalgan if you have an allergy to paracetamol or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to Perfalgan may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
You must not be given Perfalgan if you have liver failure or severe liver disease.
If you are not sure whether you should be given Perfalgan, talk to your doctor or pharmacist.
Before you are given Perfalgan
Tell your doctor or pharmacist if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Tell your doctor or pharmacist if you are pregnant
Perfalgan may be given to pregnant women, but your doctor must be told if you are pregnant.
Tell your doctor or pharmacist if you are breast-feeding
Perfalgan may be given to women who are breast-feeding, but your doctor must be told if you are breast-feeding.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
liver disease
kidney disease
alcoholism
suffer from malnutrition
dehydration
eating disorders (anorexia, bulimia)
a wasting syndrome including unexplained weight loss, fatigue, weakness and loss of appetite (cachexia)
malnutrition (low reserves of glutathione)
a metabolic condition called glucose-6-phosphate dehydrogenase deficiency (G6PD)
hypovolaemia (decreased blood volume)
If you have not told your doctor or pharmacist about any of the above, tell them before you are given Perfalgan
Taking other medicines
It is especially important to tell your doctor if you are taking any other medication, including over the counter or pharmacy medication, which contains paracetamol. This may effect the dosage of Perfalgan which you should receive.
Tell your doctor if you drink alcohol.
Your doctor may advise you to avoid alcohol as it may interfere with Perfalgan.
Some medicines and Perfalgan may interfere with each other. These include:
Pro-Cid (probenecid) - a medicine used to treat gout or given with antibiotics.
Anticonvulsants - medicines used to treat epilepsy or fits, such as Dilantin (phenytoin), Tegretol or Teril (carbamazepine), amytal sodium, phenobarbitone.
Other forms of paracetamol, such as tablets, liquid preparations or capsules
Myleron or Busulfex (busulfan) a cancer drug
Dolobid (diflunisal) an anti-inflammatory drug
Barbiturates
Retrovir (zidovudine) - a HIV drug or other drugs containing zidovudine
Anticoagulants which are use to stop the blood from clotting
Isoniazid (isoniazid) a tuberculosis drug
Antibiotics containing amoxicillin plus clavulanic acid such as Clamoxyl, Clavulan,
These medicines may be affected by Perfalgan, or may affect how well Perfalgan works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while receiving Perfalgan.
How Perfalgan is given
How much is given
Your doctor will decide what dose you will be given, and for how long you will be given Perfalgan. Tell your doctor if you have been taking other forms of Paracetamol (tablets, capsules, liquid preparations) and the quantity that you have been taking
How it is given
Perfalgan is given as a slow infusion (drip) into a vein. Perfalgan must only be given by a doctor or nurse.
Overdose
Your doctor has information on how to recognise and treat an overdose. Ask your doctor or nurse if you have any concerns.
While you are being given Perfalgan
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are being given Perfalgan.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given Perfalgan.
Tell your doctor immediately if you develop a rash or other symptoms of an allergic reaction.
These symptoms may be:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Perfalgan.
Perfalgan helps most people with pain and fever, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
feeling unwell
dizziness, light-headedness
bleeding or bruising more easily than normal
vomiting, nausea
constipation
These side effects are rare and usually mild.
If any of the following happen, tell your doctor or a nurse immediately.
These are very serious side effects. You may need urgent medical attention.
allergic reaction - shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.
Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.
Do not be alarmed by possible side effects.
You may not experience any of them.
Product description
What it looks like
Perfalgan is a clear and slightly yellowish solution, in glass vials, available in vials containing 50 mL or 100 mL .
One 50mL vial contains 500 mg paracetamol and one 100 mL vial contains 1 g of paracetamol.
Ingredients
Active Ingredient: paracetamol 10 mg/mL
Other Ingredients: mannitol, cysteine hydrochloride, sodium phosphate - dibasic dihydrate, sodium hydroxide, hydrochloric acid, water for injections.
Storage
Perfalgan will be stored in the pharmacy or on the ward. The injection should be kept in a cool dry place, protected from light, where the temperature stays below 30°C.
Manufacturer
Perfalgan is manufactured in France and distributed in Australia by
Bristol-Myers Squibb Australia Pty Ltd
556 Princes Highway
Noble Park
Victoria 3174
Registration Number:
AUST R 99870 - 500mg/50mL
AUST R 99869 - 1g/100mL
Date of Preparation: 3rd March 2011
Perfalgan(cmi)6.0.doc
