Patient leaflet - Meropenem 1000 mg powder for injection or infusion
1. WHAT MEROPENEM IS AND WHAT IT IS USED FOR
Meropenem is used to treat the following in adults and children aged 3 months and older:
- Lung and bronchial infections in patients suffering from cystic fibrosis
- Complicated urinary tract infections
- Complicated infections in the abdomen
suspected to be due to a bacterial infection.
Meropenem may be used to treat bacterial infection of the blood which might be
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEROPENEM
Do not use Meropenem if:
Warnings and precautions
before using Meropenem.
Other medicines and Meropenem
following medicines:
Pregnancy and breast-feeding
whether you should use Meropenem.
Meropenem while breast-feeding.
Driving and using machines operate machines.
side effect.
Meropenem contains sodium.
3. HOW TO USE MEROPENEM
Use in adults
you need.
Use in children and adolescents
How to use Meropenem doctor if you are not sure.
other medicines.
If you use more Meropenem than you should hospital straight away.
If you forget to use Meropenem
If you stop using Meropenem pharmacist or nurse.
The following information is intended for medical or healthcare professionals only: Instructions for giving Meropenem to yourself or someone else at home
Warning – You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.
How to prepare this medicine
you how much of the diluent to use.
Allow the rubber stopper to dry.
Dose of Meropenem Amount of ‘Water for Injections’ needed for dilution
20 ml
1.5 g 30 ml
2 g 40 ml
Please note:
one syringe.
- 6.
Put the needle of the syringe through the centre of the rubber stopper and
Meropenem.
alcohol wipe and allow the rubber stopper to dry.
The following information is intended for healthcare professionals only. For full prescribing information please refer to the SmPC.
Posology and method of administration
Posology
three times daily in children may be particularly appropriate when treating some types of
Enterobacteriaceae Pseudomonas aeruginosa Acinetobacter
Additional considerations for dosing are needed when treating patients with renal
Adults and Adolescents
Infection Dose to be administered
every 8 hours
associated pneumonia 500 mg or 1 g
Broncho-pulmonary infections in cystic fibrosis 2 g
Complicated urinary tract infections 500 mg or 1 g Complicated intra-abdominal infections 500 mg or 1 g
500 mg or 1 g 500 mg or 1 g Acute bacterial meningitis 2 g
Management of febrile neutropenic patients 1 g
Renal impairment
Creatinine clearance
(mL/min)
Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above) Frequency
26-50 one unit dose
10-25 half of one unit dose
< 10 half of one unit dose should be administered after completion of the haemodialysis cycle.
Hepatic impairment
Paediatric population
Children under 3 months of age
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4. POSSIBLE SIDE EFFECTS
Severe allergic reactions
sudden onset of:
Damage to red blood cells (not known)
Red or brown urine.
see a doctor straight away. Other possible side effects:
Common (may affect up to 1 in 10 people)
- Headache.
- Pain and inflammation.
Uncommon (may affect up to 1 in 100 people)
decreased numbers of other white cells and increased amounts of a substance called
Rare (may affect up to 1 in 1,000 people)
Reporting of side effects
5. HOW TO STORE MEROPENEM
Intravenous bolus injection administration:
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Meropenem contains
meropenem.
What Meropenem looks like and contents of the pack
Marketing Authorisation Holder
Olympia House
Unit 13, 2nd Floor, Armitage Road
London, NW11 8RQ
England
Manufacturer
Advice/medical education
Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
and for the right number of days. Read the instructions on the label and if you do and you should use it only to treat the infection for which it was prescribed.
they had an infection that was similar to yours.
safe place.
Giving the injection
port or central line.
sharps bin.
dry. Open the cap on your cannula and connect the syringe.
minutes.
syringe and use a flush as recommended by your doctor or nurse.
- 5. Close the cap of your cannula and carefully throw the syringe away in your sharps bin.
Giving Meropenem through a port or central line
and allow it to dry.
recommended by your doctor or nurse.
- 4. Place a new clean cap on your central line and carefully throw the syringe away in your sharps bin.
Children from 3 months to 11 years of age and up to 50 kg body weight
Infection Dose to be administered
every 8 hours
associated pneumonia
Broncho-pulmonary infections in cystic fibrosis
Complicated urinary tract infections
Complicated intra-abdominal infections
Acute bacterial meningitis
Management of febrile neutropenic patients
Children over 50 kg body weight
Method of administration
section 6.6.
Incompatibilities
mentioned in section 6.6.
Shelf-life
Special precautions for storage
Special precautions for disposal and other handling
Injection
Infusion
and administration.
Intravenous infusion administration:
Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution or 5% glucose solution has been demonstrated for 1 hour at up to 25 °C or under refrigerated conditions (2-8 °C).
From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbiological contamination, the product should be used immediately.
If not used immediately in-use storage times and conditions are the responsibility of the user.
Do not freeze the reconstituted solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Intravenous bolus injection administration
injection to a final concentration of 50 mg/mL. The reconstituted solutions for intravenous injection or infusion should be used immediately. The constituted solutions should not be frozen.
intravenous injection or infusion should be used immediately. The constituted solutions should not be frozen.
Intravenous infusion administration:
Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution or 5% glucose solution has been demonstrated for 1 hour at up to 25°C or under refrigerated conditions (2-8 °C).
From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbiological contamination, the product should be used immediately.
If not used immediately in-use storage times and conditions are the responsibility of the user.
glucose