Amikin Injection 100mg/2ml and 500mg/2ml

PATIENT INFORMATION LEAFLET

AMIKIN INJECTION 500mg/2ml
(Amikacin Sulphate)

AMIKIN INJECTION 100mg/2ml
(Amikacin Sulphate)

Your doctor has prescribed AMIKIN. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

WHAT IS IN AMIKIN?

The active ingredient in AMIKIN is amikacin sulphate. AMIKIN is available in two strengths: amikacin sulphate equivalent to amikacin activity 100mg in 2ml or amikacin sulphate equivalent to amikacin activity 500mg in 2ml. Amikacin is an antibiotic and a member of the family of medicines called aminoglycosides.

The other ingredients are: sodium bisulphite, sodium citrate, sulphuric acid and water for injection.

Amikin Injection is supplied in a pack of 5 vials. injection.

WHAT IS THIS MEDICINE FOR?

AMIKIN is for the treatment of serious infections caused by bacteria which require an antibiotic injection.

U.K. PRODUCT LICENCE HOLDER:

IRISH PRODUCT AUTHORISATION HOLDER:

MANUFACTURER:

BEFORE YOUR MEDICINE IS ADMINISTERED

What should my doctor know before I receive AMIKIN?

Tell your doctor if you are allergic to any of the ingredients in AMIKIN or other antibiotics. Also make sure that your doctor knows if you have had any kidney or hearing problems after receiving other antibiotics or if you suffer from myasthenia gravis or nerve problems, as large doses can aggravate these conditions.

Your doctor will not give you AMIKIN by injection into your abdomen if you are still under the effects of an anaesthetic or muscle relaxing drugs, as this may cause problems with your breathing. Also, it will not be given by injection into the abdomen if you are a young child.

What if I am pregnant?

If you are pregnant or may become pregnant, you should speak to your doctor before receiving AMIKIN.

What if I have problems with my kidneys?

Tell your doctor as the dose of AMIKIN may need to be reduced or the interval between doses extended.

Can I take other medicines?

Not unless these have been discussed with your doctor or pharmacist. These include medicines bought at a pharmacy or elsewhere, e.g. supermarket. If you are taking a diuretic, e.g. frusemide (water tablet or injection), indomethacin (antiinflammatory) or any penicillin-type antibiotic remind your doctor before AMIKIN is given.

ADMINISTRATION OF YOUR MEDICINE

How is AMIKIN given and what is the usual dose?

AMIKIN will be given by injection into a muscle or vein or occasionally into the abdomen. The usual dose for adults is 250 – 500 mg twice daily. The usual dose in children is 7.5 –15 mg/kg/day divided in two doses. The doses may be increased in certain infections. You may require hearing and kidney tests while receiving AMIKIN; also blood tests to check the amount of amikacin received.

UNDESIRABLE EFFECTS

Are there any unwanted effects of AMIKIN?

All medicines may cause some unwanted or "side-effects". In a few patients, AMIKIN may cause ringing in the ears, dizziness, deafness, rash, fever, headache, pins and needles, nausea and vomiting, and kidney problems including a reduction in urine output. If you notice any of these, or any other effects, tell your doctor, pharmacist or nurse. On rare occasions, it may be necessary to inject Amikin directly into the eyeball which can lead to visual disturbances.

LOOKING AFTER YOUR MEDICINE

You will see an "expiry date" on the packaging of AMIKIN. The injection should not be used after this date. It should not be stored above 25°C and must be kept out of the reach and sight of children. The vial is to be used once only. Any unused solution in the vial should be thrown away.

DATE OF PREPARATION: July 2005