Gentamicin Paediatric 20 Mg/2 Ml Solution For Injection
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine.
again.
doctor or pharmacist.
•
you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Gentamicin Paediatric Solution for Injection is and what it is used for
2. Before you use Gentamicin Paediatric Solution for Injection
3. How to use Gentamicin Paediatric Solution for Injection
4. Possible side effects
5. How to store Gentamicin Paediatric Solution for Injection
6. Further information
1. WHAT GENTAMICIN PAEDIATRIC SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Gentamicin Paediatric Solution for Injection contains a medicine called gentamicin sulfate. This belongs to a group of antibiotics called 'aminoglycosides'.
Gentamicin Paediatric Solution for Injection is used to treat a wide range of infections caused by bacteria in children.
These may include the treatment of infections ofthe blood (bacteraemia and septicaemia), chest infections, urinary tract infections (including your kidneys and bladder), infections in new born babies and other infections due to susceptible organisms.
Taking other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. Remember to take this medicine with you if your child has to go to hospital.
In particular tell your doctor or pharmacist if your child is taking any of the following: •
infections e.g. cephaloridine
anaesthetic
e.g.furosemide
treat myasthenia gravis
infections
for severe skin problems
swelling
warfarin
osteoporosis e.g. alendronic acid muscles
Pregnancy and breastfeeding
Ifyour child is pregnant, thinks she may be pregnant or is breastfeeding, you should tell the doctor before she is given this medicine.
Important information about one ofthe ingredients in this medicine.
This medicine contains E223 - sodium metabisulphite. This may rarely cause severe hypersensitivity reactions and bronchospasm.
3. HOWTO USE GENTAMICIN PAEDIATRIC SOLUTION FOR INJECTION
2. BEFORE YOU USE GENTAMICIN PAEDIATRIC SOLUTION FOR INJECTION
Do not use Gentamicin Paediatric Solution for Injection if your child:
•
sulfate or any of the other ingredients in this medicine
weak muscles
Take special care with Gentamicin Paediatric Solution for Injection
Consult your doctor or pharmacist before your child is given Gentamicin Paediatric Solution for Injection ifyour child has:
•
•
Your doctor will want to monitor your child during treatment with this medicine. They will monitor theirvision, hearing and kidney function, as this medicine can have an effect on them.
This product is for use in children only.
Gentamicin Paediatric Solution for Injection is given under the supervision of a doctor, who can give you more information.
Gentamicin Paediatric Solution for Injection is given into a vein from an intravenous drip or into a muscle. Your doctor will decide on the most appropriate route to use.
The dose your child receives will be determined by the doctor depending on your child's bodyweight. Blood samples will be taken by your doctor or nurse to make sure the dose is correct.
The usual dose is as follows:
Children (aged 1 year and above):
The usual daily dose is 3-6 mg per kg of body weight.
This can be given as 1 single dose (preferred) or split into 2 doses.
Babies (aged 4 weeks to 1 year of age):
The usual daily dose is 4.5-7.5 mg per kg of body weight.
This can be given as 1 single dose (preferred) or split into 2 doses.
New born babies (up to 4 weeks of age):
The usual daily dose is 4-7 mg per kg of body weight.
This is given as a single dose.
Subsequent doses may need to be increased to achieve the correct level of gentamicin required.
Children with kidney problems:
The dosage will be adjusted by your doctor.
Ifyour child is given more Gentamicin Paediatric Solution for Injection than he/she should
The dose of Gentamicin Paediatric Solution for Injection will be carefully calculated by the doctors so overdose is unlikely. However, if too much is given this is likely to make the usual side effects worse (see Section 4, Possible side effects).
If your child misses a dose of Gentamicin Paediatric Solution for Injection
Gentamicin Paediatric Solution for Injection will be given to your child by a doctor or nurse. It is most unlikely that they will not be given the medicine as it has been prescribed. If you think that a dose has been missed talk to your nurse or doctor.
Ifyour child stops having Gentamicin Paediatric Solution for Injection
It is important that the course of treatment that the doctor has prescribed is finished.
Your child may start to feel better but it is important to continue with the treatment until the doctor advises. Iftreatment is stopped the infection may get worse.
• feeling sad (depression)
• seeing, hearing or feeling something that is not real (hallucinations)
• changes in the levels of certain chemicals in the blood e.g. potassium or magnesium
• have bloody diarrhoea, with or without stomach cramps
• headache
• damage to the liver which will be picked up in a blood test during monitoring
Your child may also feel sick (nausea) or may be sick (vomiting).
If your child has any of these side effects, or if you notice any side effects not listed, please tell the doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: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 PAEDIATRIC SOLUTION FOR INJECTION
4. POSSIBLE SIDE EFFECTS
Keep out of the reach and sight of children.
Store below 25°C. Store in the original package. Protect from light.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Gentamicin Paediatric Solution for Injection, may cause your child to experience some side effects, although not everybody gets them.
If any of the following occur tell your child's doctor or nurse immediately:
•
symptoms such as rash, itching, swelling of the face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up.
•
hearing becomes poor. This is more likely to happen if your child has kidney problems.
•
or there is blood in their urine. This may mean the medicine is affecting their kidneys.
If your child experiences any of the following side effects you should talk to the doctor:
•
up in a blood test during monitoring e.g. anaemia
6. FURTHER INFORMATION
What Gentamicin Paediatric Solution for Injection contains:
Gentamicin Paediatric Solution for Injection contains the active ingredient, gentamicin sulfate.
Each 2ml ofsolution contains 20mg of gentamicin sulfate.
The other ingredients are: sodium metabisulphite (E223), sodium edetate, sodium citrate, citric acid and water for injection.
What Gentamicin Paediatric Solution for Injection looks like and contents of the pack
Gentamicin Paediatric Solution for Injection is supplied in clear glass ampoules in packs of 5 with 2ml in each ampoule
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
Alfa Wassermann SPA Via Enrico Fermi, 1,
65020 ALANNO (PE), Italy.
This leaflet was last revised in March 2013