GENTAMICIN 40MG/ML INJECTION
Active substance: GENTAMICIN SULPHATE
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Gentamicin Injection is used to treat a wide variety of infections such as chest, wound and blood infections.
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
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. 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
some diuretics (water tablets), such as ethacrynic acid and furosemide muscle relaxants used during general anaesthesia (such as tubocurarine and succinylcholine) Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 20 to 30 minutes. Any unused product or waste material should be disposed of in accordance with local requirements.
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.
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. 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 your 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.
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, cephalothin and methicillin medicines used to thin the blood, such as warfarin and phenindione amphotericin (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 bodys immune system) cisplatin (anti-cancer medicine)
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).
Q72966 4XXXXX
Treatment with gentamicin may cause damage to hearing and also to kidney function. 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This medicine is presented in glass containers called vials. It is available in packs containing 5 x 80 mg/2 ml vials
5. How to store Gentamicin Injection
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. The vials should not be stored above 25C.
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 approved in 03/2012.
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 sideeffect 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 skin rash or development of raised coloured blotches which may be itchy fever sore throat muscle weakness Your doctor may also carry out blood tests to check for changes in your kidney function.
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.
Q72966 4XXXXX
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
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. 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
some diuretics (water tablets), such as ethacrynic acid and furosemide muscle relaxants used during general anaesthesia (such as tubocurarine and succinylcholine) Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 20 to 30 minutes. Any unused product or waste material should be disposed of in accordance with local requirements.
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.
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. 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 your 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.
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, cephalothin and methicillin medicines used to thin the blood, such as warfarin and phenindione amphotericin (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 bodys immune system) cisplatin (anti-cancer medicine)
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).
Q72966 4XXXXX
Treatment with gentamicin may cause damage to hearing and also to kidney function. 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This medicine is presented in glass containers called vials. It is available in packs containing 5 x 80 mg/2 ml vials
5. How to store Gentamicin Injection
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. The vials should not be stored above 25C.
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 approved in 03/2012.
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 sideeffect 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 skin rash or development of raised coloured blotches which may be itchy fever sore throat muscle weakness Your doctor may also carry out blood tests to check for changes in your kidney function.
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.
Q72966 4XXXXX
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
