QUICK DETAILS:
GENKOMIC 80 Contents:
•Each ampoule contains Gentamicin ( as sulfate) 80mg as the active ingredient.
•The other ingredients are sodium chloride, water for injections and sodium hydroxide or sulphuric acid.
GENKOMIC 80 Character:
GENKOMIC 80 is a clear, colourless or almost colourless liquid, which comes in a glass ampoule containing 2 ml of solution.
GENKOMIC 80 Pack:
5 ampoules per tray, 2 trays per box.
1. What GENKOMIC 80 is and what it is used for
Gentamicin, the active ingredient of GENKOMIC 80, is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is usually active against most strains of the following organisms : Escherichia coli, Klebsiella spp., Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Staphylococci, Enterobacter spp., Citrobacter spp and Providencia spp.
GENKOMIC 80 is used to treat infections caused by bacteria. This includes infections of the:
•Urinary tract (including your kidneys or bladder)
2. What you need to know before you take GENKOMIC 80
Do not use GENKOMIC 80
•if you have shown signs of hypersensitivity (severe allergy) to gentamicin or any other ingredients
•if you suffer from a disorder called myasthenia gravis (severe weakness of selected muscles of the body)
•if you are pregnant or breast-feeding
•if treating premature babies
•if you experience muscle weakness
This is especially important if you are taking:
•Agalsidase alpha and beta, used to treat a rare condition called Fabry disease. These two medicines should not be used together
•Antibiotics such as penicillin, cephalosporins,vancomycin, colistin, teicoplanin and capreomycin
•Ciclosporin and tacrolimus (used to stop the body rejecting bone marrow or organ transplants)
•Cisplatin and fludarabine
•Muscle relaxants
•Indomethacin (an anti-inflammatory)
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and lactation
Driving and using machines
•Chest (including your lungs)
•Blood - this is sometimes called 'bacteraemia' or 'septicaemia'.
Take special care with GENKOMIC 80
•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 are very overweight
Taking other medicines
•Amphotericin (used to treat fungal infections)
•Furosemide (frusemide), digoxin and piretanide (used to treat heart problems)
•Medicines used to treat myasthenia gravis such as neostigmine and pyridostigmine
•Biphosphonates (used to treat osteoporosis)
•Medicines containing oestrogens (used for contraception)
Gentamicin Injection will not normally be used if you are pregnant or breast-feeding.
Do not drive if you experience any effect which may impair your ability to drive or use machines.
1.How to take GENKOMIC 80
This medicine will be given to you by a doctor or nurse as an injection into a muscle or vein. It can also be given as a drip (infusion). Your doctor will work out the dose which is suitable for you.
The daily recommended dose in children, adolescents and adults with normal kidney function is 3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses.
The daily dose in infants after the first month of life is 4.5 - 7.5 mg/kg of body weight per day as one (preferred) up to two single doses.
The daily dose in newborns is 4-7 mg/kg of body weight per day.Due to the longer half-life, newborns are given the required daily dose in one single dose. The dose for the elderly, children under 12 years and patients with kidney problems will be adjusted accordingly.
2. Possible side effects
Like all medicines, GENKOMIC 80 can cause side effects, although not everybody gets them.
Tell your doctor or nurse as soon as possible if any of the following side effects happen:
Ear problems: these may happen because Cidomycin can sometimes damage the ear, especially if your kidneys do not work very well. The side effects are:
•Difficulty keeping your balance
Kidney problems: if you notice anything unusual when you pass water, such as:
•If you see any sign of blood in your water (urine)
If you are not sure if you have any of the above, talk to your doctor or nurse as soon as possible.
Tell your doctor or nurse if any of the following side effects gets serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.
•Allergic reactions, such as nettle rash or difficulty breathing
•Feeling dizzy
•Poor hearing.
•If you find you are passing less water than is normal for you.
Nerve or muscle problems:
•If you have unusual difficulty in moving which has not happened before
•If you have a feeling of weakness or unusual tiredness
•If you have any breathing difficulties that have not happened before
•Headache
•Feeling tired
•Purplish or reddish-brown skin colouring
•Mouth ulcers
•Feeling or being sick (nausea or vomiting)
•Rash
•Bloody diarrhoea
•Fits or convulsions
•Feeling confused
•Depression
•Strange visions or sounds (hallucination) and memory loss
Contents of the pack and other information
What GENKOMIC 80 contains
•Each ampoule contains Gentamicin ( as sulfate) 80mg as the active ingredient.
•The other ingredients are sodium chloride, water for injections and sodium hydroxide or sulphuric acid.
What GENKOMIC 80 looks like and contents of the pack
GENKOMIC 80 is a clear, colourless or almost colourless liquid, which comes in a glass ampoule containing 2 ml of solution.
5 ampoules per tray, 2 trays per box.
How to store GENKOMIC 80
GENKOMIC 80 must not be used after the expiry date ‘EXP’ shown on the container.
Keep out of the reach and sight of children.
Do not store above 25°C. Keep in the outer carton.
QUICK DETAILS:
•The other ingredients are sodium chloride, water for injections and sodium hydroxide or sulphuric acid.
GENKOMIC 80 Character:
GENKOMIC 80 is a clear, colourless or almost colourless liquid, which comes in a glass ampoule containing 2 ml of solution.
GENKOMIC 80 Pack:
5 ampoules per tray, 2 trays per box.
GENKOMIC 80 Contents:
•Each ampoule contains Gentamicin ( as sulfate) 80mg as the active ingredient.
1. What GENKOMIC 80 is and what it is used for
Gentamicin, the active ingredient of GENKOMIC 80, is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is usually active against most strains of the following organisms : Escherichia coli, Klebsiella spp., Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Staphylococci, Enterobacter spp., Citrobacter spp and Providencia spp.
GENKOMIC 80 is used to treat infections caused by bacteria. This includes infections of the:
•Urinary tract (including your kidneys or bladder)
2. What you need to know before you take GENKOMIC 80
Do not use GENKOMIC 80
•if you have shown signs of hypersensitivity (severe allergy) to gentamicin or any other ingredients
•if you suffer from a disorder called myasthenia gravis (severe weakness of selected muscles of the body)
•if you are pregnant or breast-feeding
•if treating premature babies
•if you experience muscle weakness
This is especially important if you are taking:
•Agalsidase alpha and beta, used to treat a rare condition called Fabry disease. These two medicines should not be used together
•Antibiotics such as penicillin, cephalosporins,vancomycin, colistin, teicoplanin and capreomycin
•Ciclosporin and tacrolimus (used to stop the body rejecting bone marrow or organ transplants)
•Cisplatin and fludarabine
•Muscle relaxants
•Indomethacin (an anti-inflammatory)
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and lactation
Driving and using machines
•Chest (including your lungs)
•Blood - this is sometimes called 'bacteraemia' or 'septicaemia'.
Take special care with GENKOMIC 80
•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 are very overweight
Taking other medicines
•Amphotericin (used to treat fungal infections)
•Furosemide (frusemide), digoxin and piretanide (used to treat heart problems)
•Medicines used to treat myasthenia gravis such as neostigmine and pyridostigmine
•Biphosphonates (used to treat osteoporosis)
•Medicines containing oestrogens (used for contraception)
Gentamicin Injection will not normally be used if you are pregnant or breast-feeding.
Do not drive if you experience any effect which may impair your ability to drive or use machines.
1.How to take GENKOMIC 80
This medicine will be given to you by a doctor or nurse as an injection into a muscle or vein. It can also be given as a drip (infusion). Your doctor will work out the dose which is suitable for you.
The daily recommended dose in children, adolescents and adults with normal kidney function is 3 - 6 mg/kg of body weight per day as one (preferred) up to two single doses.
The daily dose in infants after the first month of life is 4.5 - 7.5 mg/kg of body weight per day as one (preferred) up to two single doses.
The daily dose in newborns is 4-7 mg/kg of body weight per day.Due to the longer half-life, newborns are given the required daily dose in one single dose. The dose for the elderly, children under 12 years and patients with kidney problems will be adjusted accordingly.
2. Possible side effects
Like all medicines, GENKOMIC 80 can cause side effects, although not everybody gets them.
Tell your doctor or nurse as soon as possible if any of the following side effects happen:
Ear problems: these may happen because Cidomycin can sometimes damage the ear, especially if your kidneys do not work very well. The side effects are:
•Difficulty keeping your balance
Kidney problems: if you notice anything unusual when you pass water, such as:
•If you see any sign of blood in your water (urine)
If you are not sure if you have any of the above, talk to your doctor or nurse as soon as possible.
Tell your doctor or nurse if any of the following side effects gets serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet.
•Allergic reactions, such as nettle rash or difficulty breathing
•Feeling dizzy
•Poor hearing.
•If you find you are passing less water than is normal for you.
Nerve or muscle problems:
•If you have unusual difficulty in moving which has not happened before
•If you have a feeling of weakness or unusual tiredness
•If you have any breathing difficulties that have not happened before
•Headache
•Feeling tired
•Purplish or reddish-brown skin colouring
•Mouth ulcers
•Feeling or being sick (nausea or vomiting)
•Rash
•Bloody diarrhoea
•Fits or convulsions
•Feeling confused
•Depression
•Strange visions or sounds (hallucination) and memory loss
Contents of the pack and other information
What GENKOMIC 80 contains
•Each ampoule contains Gentamicin ( as sulfate) 80mg as the active ingredient.
•The other ingredients are sodium chloride, water for injections and sodium hydroxide or sulphuric acid.
What GENKOMIC 80 looks like and contents of the pack
GENKOMIC 80 is a clear, colourless or almost colourless liquid, which comes in a glass ampoule containing 2 ml of solution.
5 ampoules per tray, 2 trays per box.
How to store GENKOMIC 80
GENKOMIC 80 must not be used after the expiry date ‘EXP’ shown on the container.
Keep out of the reach and sight of children.
Do not store above 25°C. Keep in the outer carton.
