Miacin is one of a group of antibiotic medicines called ‘aminoglycosides’.

Miacin is used in the treatment of serious infections caused by bacteria sensitive to amikacin.

Do not use Miacin

• If you have shown signs of hypersensitivity (severe allergy) to amikacin, or any of the other ingredients listed in section 6, in the past
• If you suffer from a disorder called myasthenia gravis (severe weakness of certain muscles of the body)

Tell your doctor if any of the above applies to you before this medicine is used.

Warnings and precautions
Talk to your doctor before using Miacin:

• If you have kidney problems
• If you have hearing difficulties or tinnitus (ringing or buzzing in the ears)
• If you have shown signs of allergy to any of the antibiotics related to amikacin (aminoglycosides) in the past
• If you or your family members have a mitochondrial mutation disease (condition caused by variants in the genome of mitochondria, the parts of your cells which help make energy) or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may increase your risk of hearing loss with this product
• If you have a known allergy to sulphites

Tell your doctor if any of the above applies to you before this medicine is used.

Children
Miacin should be used with caution in premature and neonatal infants.

Other medicines and Miacin
Tell your doctor if you are taking, have recently taken or might take/use any other medicines.

Special care is needed if you are taking/using other medicines, as some could interact with amikacin for example:

• Diuretics (water tablets) such as furosemide and ethacrynic acid
• Other antibiotics that can affect your kidneys, hearing or balance
• Anaesthetics or muscle-relaxing drugs
• Indomethacin (an anti-inflammatory medicine)
• Other antibiotics called beta-lactamases such as penicillins or cephalosporins
• Bisphosphonates; drugs used to treat loss of bone mass
• Vitamin B1 (thiamine)
• Platinum compounds used in chemotherapy such as cisplatin

Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will only use this medicine if the expected benefits outweigh any potential risk to your baby.

Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness) which may lessen your ability to do so.

Miacin contains sodium and sodium metabisulphite
Miacin contains sodium. Each 2 ml of Miacin 500 mg/2 ml Solution for Injection/Infusion contains 0.656
mmol (15.088 mg) sodium. This medicine contains less than 1 mmol sodium (23 mg) per 2 ml, that is to say essentially ‘sodium-free’.

Miacin contains sodium metabisulphite. Each 2 ml of Miacin 500 mg/2 ml Solution for Injection/Infusion
contains 13.181 mg sodium metabisulphite.  May rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine is usually injected into a muscle. It may also be given into a vein, either as an injection or (following dilution) as an infusion (drip).

Miacin can also be given into the peritoneum (abdominal cavity) during surgery, and can be used to wash out abscess cavities, the lung cavity and brain cavities.

Your doctor will ensure you are well hydrated before and during treatment.

Dose
Your doctor will work out the correct dose of amikacin for you and how often it must be given. This may require blood tests before treatment.

The dose will depend upon your age, the infection you have, how well your kidneys are working, if you have poor hearing and any other medicines you may be taking.

It will usually be given to you two or three times a day, for up to 10 days.

Adults and children over 12 years:
The usual dose is 15 mg per kg per day which is administered as a single dose or divided into two equal doses of 7.5 mg per kg administered every 12 hours. The total dose should not exceed 1.5 g. When treatment is given in to a vein it is usually administered over a 30 to 60 minute period.

Children up to 12 years:
The usual dose is 15 – 20 mg per kg of body weight once a day or divided into two equal doses of 7.5 mg per kg which is administered every 12 hours.

Neonates:
The initial dose is 10 mg per kg of body weight followed by 7.5 mg per kg every 12 hours.

Premature infants:
The recommended dosing in premature babies is 7.5 mg per kg every 12 hours.

During treatment you may undergo blood tests and be asked to provide urine samples. You will possibly also have hearing tests before and during treatment to look for signs of side effects. Your doctor may change your dose depending upon the results of these tests.

If you are given too much or too little Miacin
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happens, tell your doctor immediately as these are all serious. You may need urgent medical attention or hospitalisation.
Rare side-effects may affect up to 1 in 1,000 people are listed below:

• Ringing in your ears or loss of hearing
• Decrease in the amount of urine you produce

Not known: frequency cannot be estimated from available data are listed below:

• Severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• Paralysis
• Deafness
• Sudden loss of breathing
• Severe kidney failure

These are serious side effects. You may need urgent medical attention.

If any of the following happens, tell your doctor as soon as possible:
Uncommon side-effects may affect up to 1 in 100 people are listed below:

• Skin rash
• Nausea and vomiting
• An excessive build up of bacteria or yeast which are resistant to amikacin

Rare side-effects may affect up to 1 in 1,000 people are listed below:

• Dizziness or vertigo (spinning sensation)
• Headache
• Fever
• Unusually low amount of red blood cells in the blood (anaemia) or excessive amounts of the white blood cells known as eosinophils in the blood (eosinophilia)
• Low levels of magnesium in the blood
• Abnormal tingling or ‘pins and needles’ sensation
• Muscle tremors
• Joint pain
• Low blood pressure
• Itching or hives

Amikacin may lead to changes in your kidney function. Your doctor may take blood and urine samples to monitor for changes such as increased levels of creatinine or nitrogen in the blood and protein or red/white blood cells in urine. Your doctor may also ask you to undergo hearing tests.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Store in the original package.

Unused portions of opened ampoules must not be stored for later use.

Prepared injections or infusions should be used immediately, however, if this is not possible they can be stored for up to 24 hours at room temperature.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

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