Gentamicin Paediatric 20 Mg/2 Ml Solution For Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gentamicin Paediatric 20mg/2ml Solution for Injection
(gentamicin sulfate)
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in the leaflet.
See section 4.
What is in this leaflet:
1. What Gentamicin Paediatric Solution for Injection is and what it is used for
2. What you need to know 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. Contents of the pack and other information
1. WHATGENTAMICIN 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 of the 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE GENTAMICIN PAEDIATRIC SOLUTION FOR INJECTION
Your doctor will want to monitor your child during treatment with this medicine. They will monitortheirvision, hearingand kidney function, as this medicine can have an effect on them.
Other medicines and Gentamicin Paediatric Solution for Injection
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 ofthe following:
• Cephalosporin antibiotics used to treat infections e.g. cephaloridine
• Curare-type muscle relaxants given under anaesthetic
• Diuretics used to treat high blood pressure e.g.furosemide
• Neostigmine and pyridostigmine used to treat myasthenia gravis
• Medicines to treat cancer e.g. cisplatin
• Amphoteracin B used to treat fungal infections
• Ciclosporin used in organ transplants or for severe skin problems
• Indometacin used to treat pain and swelling
• Medicines used to stop blood clotting e.g. warfarin
• Bisphosphonates used to treat osteoporosis e.g. alendronic acid
• Botulinum toxin used to treat over active muscles
Pregnancy and breastfeeding
If your child is pregnant, thinks she may be pregnant or is breastfeeding, you should tell the doctor before she is given this medicine.
Gentamicin Paediatric Solution for Injection contains sodium metabisulpite
This medicine contains E223 - sodium metabisulphite. This may rarely cause severe hypersensitivity reactions and bronchospasm.
3. HOW TO USE GENTAMICIN PAEDIATRIC SOLUTION FOR INJECTION
Your child should not be given Gentamicin Paediatric Solution for Injection if:
• they are allergic (hypersensitive) to gentamicin sulfate or any of the other ingredients in this medicine
• they have a condition called myasthenia gravis - weak muscles.
Warnings and precautions
Consult your doctor or pharmacist before your child is given Gentamicin Paediatric Solution for Injection if your child :
• has hearing problems
• has kidney problems
• has liver problems
• is extremely overweight
• has any muscle weakness problems.
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 body weight. Blood samples will be taken by your doctor or nurse to make sure the dose is correct.
INFORMATION FOR HEALTHCARE PROFESSIONALS
PLEASE DETACH BEFORE HANDING ABOVE
SECTION TO THE PATIENT
Gentamicin Paediatric Solution for Injection
Below is a summary of information to assist in the administration of Gentamicin Paediatric Solution for Injection.
Please refer to SPC for complete prescribing information.
For paediatric use only.
Instructions for administration
Gentamicin Paediatric 20mg/2ml Solution for Injection is normally administered intramuscularly but may be given intravenously if required.
If intravenous administration is necessary the normal intramuscular dose should be given as a bolus injection into the tubing of the giving set or directly into the venous system over a period of two or three minutes. Gentamicin should not be given as a slow infusion or mixed with other drugs before use.
With either method of administration the following dosage applies:
Dosage:
Children with normal renal function
• 3-6mg/kg body weight per day as 1 (preferred) up to 2 single doses.
• The daily dose in infants after the first month of life is 4.5-7.5mg/kg body weight per day as 1 (preferred) up to 2 single doses.
• The daily dose in newborns is 4-7mg/kg body weight per day. Due to the longer half life, newborns are given the required daily dose in 1 single dose.
In neonates, infants and children, subsequent dosage will often need to be increased to achieve therapeutic serum levels. Peak levels should be measured about one hour after intramuscular or intravenous injection and should reach 4 micrograms/ml, but not exceed 10 micrograms/ml.
Trough levels can be measured just prior to the next injection.
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 ofgentamicin 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).
Ifyour 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. If treatment is stopped the infection may get worse.
4. POSSIBLE SIDE EFFECTS
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:
• allergic reactions may occur rarely, with symptoms such as rash, itching, swelling ofthe face, wheeziness, shortness of breath, tightness in the chest, fever, low blood pressure and feeling dizzy particularly when standing up.
• losing balance, feeling dizzy or their hearing becomes poor. This is more likely to happen if your child has kidney problems.
• your child is passing less water than usual or there is blood in their urine. This may mean the medicine is affecting their kidneys.
Ifyour child experiences any ofthe following side effects you should talk to the doctor:
• changes in the blood, which will be picked up in a blood test during monitoring e.g. anaemia
• skin rashes
• itching
• mouth ulcers
• fits or convulsions
• feeling confused
• feeling tired with no energy (lethargy)
• 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).
Reporting of side effects
If your child gets 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
Keep out of the sight and reach of children.
This medicine will be given by a doctor.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Gentamicin Paediatric Solution for Injection contains:
Gentamicin Paediatric Solution for Injection contains the active ingredient, gentamicin sulfate. Each 2ml ofsolution contains 20mg ofgentamicin sulfate.
The other ingredients are: sodium metabisulphite (E223), sodium edetate, sodium citrate, citric acid and waterfor injection.
What Gentamicin Paediatric Solution for Injection looks like and contents ofthe 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 July 2015
Children with impaired renal function
The recommended daily dose should be decreased and adjusted to the renal function. The following table for adults can serve as a guideline to these modified doses:
|
Blood Urea (mg/100ml) |
Creatinine Clearance (GFR) (ml/minute) |
Dose and frequency of administration |
|
<40 |
>70 |
80mg* 8 hourly |
|
40-100 |
30-70 |
80mg* 12 hourly |
|
100-200 |
10-30 |
80mg* daily |
|
>200 |
5-10 |
80mg* every 48 hours |
|
Twice-weekly intermittent haemodialysis |
<5 |
80mg* after dialysis |
*60mg if bodyweight <60kg (80mg=80,000 I.U.)
Monitoring
Serum concentration monitoring ofgentamicin is recommended, especially in elderly, in newborns and in patients with impaired renal function. Samples are taken at the end of a dosing interval (trough level). Trough levels should not exceed 2pg/ml administering gentamicin twice daily and 1pg/ml for a once daily dose.