Gentamicin 40mg/Ml Injection
ft
hospira
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gentamicin 40 mg/ml Injection
Read all of this leaflet
carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Gentamicin Injection is and what it is used for
2. Before you use Gentamicin Injection
3. How to use Gentamicin Injection
4. Possible side effects
5. How to store Gentamicin Injection
6. Further Information
1. WHAT GENTAMICIN
INJECTION IS AND WHAT IT IS USED FOR
Gentamicin Injection is an aminoglycoside antibiotic medicine, in the form of a solution for injection (a solution which can be given as an injection).
Gentamicin Injection is used to treat a wide variety of infections such as chest, wound and blood infections.
2. BEFORE YOU USE GENTAMICIN INJECTION
Do not use Gentamicin
Injection
• if you have shown signs of hypersensitivity (severe allergy) to gentamicin or any other ingredients listed in section 6 on previous occasions
• if you suffer from a disorder called myasthenia gravis (severe weakness of selected muscles of the body)
• if you are pregnant or breast-feeding
Take special care with
Gentamicin Injection
• if treating premature babies
• if you are an elderly patient
• if your kidneys are not working properly
• if you have diabetes
• if you have an ear, hearing or balance disorder, a history of ear infections or if you have been treated with medicines that affect hearing in the past
• if you experience muscle weakness
• if you are very overweight
Taking/using other medicines
Special care is needed if you
are taking/using other medicines
such as:
• antibiotics that also affect your kidneys or hearing such as other aminoglycosides, cephalosporins, (notably cephalothin) and methicillin
• medicines used to thin the blood, such as warfarin and phenindione
• amphotericin B (medicine used to treat fungal infections)
• neostigmine and pyridostigmine (medicines used in the treatment of muscle weakness)
• cyclosporin (a medicine that reduces the activity of the body’s immune system)
• cisplatin (anti-cancer medicine)
• some diuretics (water tablets), such as ethacrynic acid and furosemide
• muscle relaxants used during general anaesthesia (such as tubocurarine and succinylcholine)
• indomethacin (one of a group of medicines called non-steroidal anti-inflammatory agents used to treat pain and inflammations)
• biphosphonates (group of medicines used to treat e.g. osteoporosis)
• Botulinum Toxin (medicine used for the treatment
of muscle spasticity, an involuntary flexing of the muscles)
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Gentamicin Injection will not normally be used if you are pregnant or breast-feeding.
Driving and using machines
Do not drive if you experience any effect which may impair your ability to drive or use machines. The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
The following information is intended for medical or healthcare professionals only:
Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Instructions for use, handling and disposal
The prescribed dose may be dissolved in up to 100 ml of normal saline or 5% glucose in water, but not solutions containing bicarbonate, and the solution infused over a period of no longer than 20 minutes.
Any unused product or waste material should be disposed of in accordance with local requirements.
3. HOW TO USE GENTAMICIN INJECTION
The dose of medicine given to you will depend on how serious the infection is, your age, body weight and how well your kidneys are working.
The medicine is usually injected into a muscle but may also be injected into a vein in some patients.
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If it is given into a vein, it can either be given as an injection or dissolved with, e.g. saline or 5% glucose in water and given as a slow injection via a drip (infusion). It will be given daily,
with your dose usually divided into two or three separate doses. As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell you doctor or pharmacist if you have any concerns.
The amount of gentamicin in your blood will be measured regularly to check that the correct blood levels have been achieved. Treatment with gentamicin may cause damage to hearing and also to kidney function. Your doctor will decide, depending on your condition, how long you should receive gentamicin. In some cases, your doctor may carry out blood tests to check your kidney function before and during treatment with gentamicin. Occasionally you may also be asked to take a hearing test to check the drug is not affecting your hearing.
4. POSSIBLE SIDE-EFFECTS
Like all medicines Gentamicin Injection can cause side-effects, although not everybody gets them. If any of the following happen, please tell your doctor immediately
• 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.
This is a very serious side-effect. You may need urgent medical attention. This very serious side-effect is rare.
If you experience any of the following tell your doctor as soon as possible:
• hearing problems (if you have this side-effect your doctor may need to change your dose or give you other treatments)
• feeling or being sick, (nausea or vomiting)
• skin rash or development of raised coloured blotches which may be itchy
• purple discolouration under the skin
• fever
• sore throat and mouth
• muscle weakness
• kidney disease with symptoms such as reduced urine output
• low blood cell counts (red and white blood cells) and further blood abnormalities or disorders (known as blood dyscrasia)
• damage to the brain with signs such as seizures, confusion, tiredness, depression and hallucinations
• liver problems
• low potassium or calcium levels in the blood
• low magnesium levels in the blood with prolonged treatment
Your doctor may also regularly carry out blood tests to check for changes in your blood cells, electrolytes (such as potassium, calcium and magnesium) in your blood, kidney and liver function, as well as hearing tests.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www. mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE GENTAMICIN INJECTION
6. FURTHER INFORMATION
What Gentamicin Injection contains
The active substance is Gentamicin sulphate.
Each millilitre (ml) of gentamicin injection contains 40 milligrams (mg) of gentamicin (as sulphate). The other ingredients are sodium metabisulphite (E223), disodium edetate, methyl hydroxybenzoate (E218), propyl hydroxybenzoate, sulphuric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and Water for Injections.
Contains preservative.
What Gentamicin Injection looks like and contents of the pack
This medicinal product is a solution for injection (a solution which can be given as an injection). The solution for injection is a clear, colourless solution.
This medicine is presented in glass containers called vials. It is available in packs containing 5 x 80 mg/2 ml vials
Marketing Authorisation Holder and manufacturer responsible for batch release in Europe:
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK. The manufacturer is Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170, Australia.
This leaflet was last revised in May 2015.
Keep out of the reach and sight of children.
Do not use Gentamicin Injection after the expiry date printed on the vial label and carton. The expiry date refers to the last day of that month.
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The vials should not be stored above 25°C.