Consumer medicine information

Meropenem Kabi

Meropenem

BRAND INFORMATION

Brand name

Meropenem Kabi Powder for injection

Active ingredient

Meropenem

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Meropenem Kabi.

What is in this leaflet

This leaflet answers some common questions about Meropenem Kabi. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking Meropenem Kabi against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again.

What is Meropenem Kabi used for

Meropenem is an antibiotic used in adults and children to treat certain serious infections caused by bacteria, such as:

  • Infections of the lungs
  • Infections of the kidney or bladder (urinary tract infection)
  • Febrile neutropaenia
  • Infections around the stomach or bowel
  • Infections of the vagina and womb
  • Serious skin infections
  • Infections in the lining of the brain (meningitis)
  • Infections in the blood stream (septicaemia)

Meropenem belongs to a group of medicines called carbapenem antibiotics. These medicines work by killing the bacteria that are causing your infection.

Meropenem will not work against fungal or viral infections (such as colds or flu).

Meropenem is an injection and is usually only used in hospitals. It is available only with a doctor's prescription.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

Meropenem is not addictive.

Meropenem Kabi is not recommended for use in children under the age of 3 months.

Safety and effectiveness in children younger than 3 months have not been established.

Before you are given Meropenem Kabi

When you must not be given Meropenem Kabi

Do not use Meropenem Kabi if you have an allergy to:

  • any medicine containing meropenem
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

If you are not sure whether you should use this medicine, talk to your doctor.

Before you are given Meropenem Kabi

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • Gastrointestinal or stomach problems, particularly colitis
  • Liver or kidney problems, including dialysis

Tell your doctor if you have an allergy to any other antibiotics such as other carbapenems, penicillins, cephalosporins or monobactams.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/ her before you are given Meropenem Kabi.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Meropenem Kabi may interfere with each other. These include:

  • Probenecid - a medicine used to treat gout
  • Sodium valproate - a medicine used to treat epilepsy or mania

These medicines may be affected by Meropenem Kabi or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Meropenem Kabi is given

Meropenem Kabi is injected into your vein. It must always be given by a doctor or nurse.

Many people who get Meropenem Kabi in hospital will have a drip (intravenous line). Meropenem Kabi can be given directly into the vein or the drip without any need for an injection through the skin. It is given either as a slow injection over approximately 5 minutes or as a slow drip over 15 to 30 minutes.

Your doctor will decide which is best for you.

How much will you be given

Your doctor will decide what dose of Meropenem Kabi you will need depending on certain factors such as your type of infection and your age. The usual dose is 500mg to 1g injected every 8 hours. If you have meningitis you may require more, while a lower dose may be used for children or if you have kidney problems.

How long will you need to be given Meropenem Kabi

Meropenem Kabi needs to be given as a series of injections over a few days. Your doctor will decide how many days you will need to have Meropenem Kabi for.

If you take too much (overdose)

If you are concerned that you have been given too much Meropenem Kabi, tell your doctor, nurse or pharmacist immediately.

For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

While you are using Meropenem Kabi

Things you must do

If you develop severe diarrhoea, tell your doctor, nurse or pharmacist immediately. Do this even if it occurs several weeks after you have been given Meropenem Kabi. It may mean that you have a serious bowel condition and you may need urgent medical attention. Do not take any medicine for your diarrhoea without checking with your doctor first.

Meropenem has been associated with headache, tingling or prickling skin and convulsions / seizures (fits). Any of these could affect your ability to drive or operate machines.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Meropenem Kabi.

This medicine helps most people with serious infections, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Pain, swelling or redness around the injection site
  • Nausea and/or vomiting
  • Diarrhoea
  • Skin rash
  • Itchiness

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Tell your doctor or pharmacist immediately if you notice any of the following:

  • Severe diarrhoea, even if it occurs several weeks after you have been given Meropenem Kabi.
  • Allergic reactions - symptoms may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • Convulsions / seizures (fits)
  • Unexpected breathlessness and/or red/brown urine - this may indicate damage to your red blood cells

The above list includes serious side effects which may require medical attention. Serious side effects are rare.

Occasionally, Meropenem Kabi may be associated with changes in your blood that may require your doctor to do certain blood tests.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

After using Meropenem Kabi

Storage

The hospital staff will store Meropenem Kabi in a safe place at a temperature below 25°C. They will check that the expiry date has not passed.

Disposal

The hospital staff will dispose of any unused Meropenem Kabi.

Product Description

What Meropenem Kabi looks like

Meropenem Kabi powder for injection comes as a sterile white to light yellow powder in a 20mL glass vial closed with rubber closures and sealed with aluminium-plastic flip-off caps (violet for 500 mg and grey for 1 g). The hospital staff then makes it into a solution ready for intravenous use.

Ingredients

Vials of Meropenem Kabi powder for injection contain either 500mg or 1g of meropenem (as the trihydrate form) as the active ingredient. They also contain sodium carbonate, an inactive ingredient that helps Meropenem to dissolve.

Meropenem Kabi powder of injection does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Australian Registration Number

Meropenem Kabi powder for injection 500mg (20mL vial):
AUST R 196965

Meropenem Kabi powder for injection 1g (20mL vial):
AUST R 196966

BRAND INFORMATION

Brand name

Meropenem Kabi Powder for injection

Active ingredient

Meropenem

Schedule

S4

 

1 Name of Medicine

Meropenem, as meropenem trihydrate.

6.7 Physicochemical Properties

The chemical name of meropenem trihydrate is - Azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 3-[[5-[(dimethylamino)carbonyl]-3- pyrrolidinyl]thio]-6-(1-hydroxyethyl)- 4-methyl-7-oxo, trihydrate, [4R-[3(3S*,5S*),4α,5β,6β(R*)]]-. (4R,5S,6S)-3-[[(3S,5S)-5-(dimethylcarbamoyl)-3-pyrrolidinyl]thio] -6-[(1R)-1-hydroxyethyl]-4-methyl- 7-oxo-1-azabicyclo[3.2.0]hept-2-ene-carboxylic acid, trihydrate.

Chemical structure.

Meropenem trihydrate has the following structural formula:

CAS number.

119478-56-7.
Molecular Formula of meropenem trihydrate is C17H25N3O5S.3H2O.

2 Qualitative and Quantitative Composition

See Table 1.

3 Pharmaceutical Form

Meropenem Kabi powder for intravenous injection is presented as a sterile white or light yellow powder containing meropenem trihydrate equivalent to meropenem, 500 mg or 1 g, blended with sodium carbonate. Meropenem Kabi powder for intravenous injection contains 208 mg sodium carbonate for each gram of meropenem (anhydrous potency). It contains no preservative.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Meropenem is a carbapenem antibiotic for parenteral use, that is stable to human dehydropeptidase-1 (DHP-1).

Microbiology.

Meropenem exerts its bactericidal action by interfering with vital bacterial cell wall synthesis. The ease with which it penetrates bacterial cell walls, its high level of stability to all serine β-lactamases and its marked affinity for the penicillin binding proteins (PBPS) explain the potent bactericidal action of meropenem against a broad spectrum of aerobic and anaerobic bacteria. Bactericidal concentrations are commonly the same as the minimum inhibitory concentrations (MICs).
Meropenem is stable in susceptibility tests and these tests can be performed using normal routine methods. In vitro tests show that meropenem acts synergistically with various antibiotics. It has been demonstrated both in vitro and in vivo that meropenem has a postantibiotic effect.
Meropenem is usually active, in vitro and in clinical infections, against the strains of bacteria shown below.

Gram positive aerobes.

Enterococcus faecalis, Staphylococcus aureus (penicillinase negative and positive), Staphylococci coagulase negative including Staphylococcus epidermidis, Streptococci including Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus mitis, Streptococcus milleri, Streptococcus sanguis, Streptococcus viridans.

Gram negative aerobes.

Acinetobacter anitratus, Citrobacter spp., including Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, and other Enterobacter spp., Escherichia coli, Haemophilus influenzae (including β-lactamase positive strains), Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Klebsiella pneumoniae, and other Klebsiella spp., Morganella morganii, Proteus mirabilis, Serratia spp.

Anaerobic bacteria.

Bacteroides fragilis, Bacteroides thetaiotaomicron, and other Bacteroides spp., Clostridium spp. including C. perfringens, Eubacterium lentum, Fusobacterium spp., Mobiluncus curtisii, Peptostreptococcus spp., Peptococcus spp.
Some strains of Pseudomonas aeruginosa are susceptible to meropenem in vitro and in clinical infections.
Enterococcus faecium, Stenotrophomonas (Xanthomonas) maltophilia, and methicillin resistant staphylococci have been found to be resistant to meropenem.

Disc susceptibility.

Dilution of diffusion techniques, either quantitative (MIC) or breakpoint, should be used following a regularly updated, recognised and standardised method, (e.g. NCCLS). Standard susceptibility test procedure require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.
A report of "susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of "intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable, other therapy should be selected.

Note.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

The pharmacokinetics are linear over the dose range of 10 to 40 mg/kg.

Absorption.

A 30 minute intravenous infusion of a single dose of meropenem in normal volunteers results in peak plasma levels of approximately 11 microgram/mL for the 250 mg dose, 23 microgram/mL for the 500 mg dose, 49 microgram/mL for the 1 g dose and 115 microgram/mL following the 2 g dose.
A 5 minute intravenous bolus injection of meropenem in normal volunteers results in peak plasma levels of approximately 52 microgram/mL for the 500 mg dose and 112 microgram/mL for the 1 g dose.
Intravenous infusions over 2 minutes, 3 minutes and 5 minutes of a 1 g dose of meropenem were compared in a three way crossover trial. These durations of infusion resulted in peak plasma levels of 110, 91 and 94 microgram/mL, respectively.
After an intravenous dose of 500 mg, plasma levels of meropenem decline to values of 1 microgram/mL or less, 6 hours after administration.

Distribution.

When multiple doses are administered at 8 hourly intervals to subjects with normal renal function, accumulation of meropenem does not occur.
Plasma protein binding of meropenem is approximately 2%.
Meropenem penetrates well into most body fluids and tissues including cerebrospinal fluid of patients with bacterial meningitis, achieving concentrations in excess of those required to inhibit most bacteria.

Metabolism.

The only metabolite of meropenem is microbiologically inactive.
In subjects with normal renal function, meropenem's elimination half-life is approximately one hour.

Excretion.

Approximately 70% of the intravenous administered dose is recovered as unchanged meropenem in the urine over 12 hours, after which little further urinary excretion is detectable. Urinary concentrations of meropenem in excess of 10 microgram/mL are maintained for up to 5 hours at the 500 mg dose. No accumulation of meropenem in plasma or urine was observed with regimens using 500 mg administered every 8 hours or 1 g administered every 6 hours in volunteers with normal renal function.
Studies in children have shown that the pharmacokinetics of meropenem in children are essentially similar to those in adults. The elimination half-life for meropenem was approximately 1.5 hours in children under the age of 2 years.
Pharmacokinetic studies in patients with renal insufficiency have shown the plasma clearance of meropenem correlates with creatinine clearance. Dosage adjustments are necessary in subjects with renal impairment.
Pharmacokinetic studies in the elderly have shown a reduction in plasma clearance of meropenem which correlated with age associated reduction in creatinine clearance.
Pharmacokinetic studies in patients with liver disease have shown no effects of liver disease on the pharmacokinetics of meropenem.

5.3 Preclinical Safety Data

Genotoxicity.

Meropenem, with and without metabolic activation as appropriate, was not genotoxic in assays for gene mutations (Salmonella typhimurium, E. coli and Chinese hamster ovary cells) and chromosomal damage (mouse micronucleus assay and human lymphocytes in vitro).

Carcinogenicity.

The carcinogenic potential of meropenem has not been investigated.

4 Clinical Particulars

4.1 Therapeutic Indications

Meropenem Kabi is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics.
Community acquired lower respiratory tract infection.
Hospital acquired lower respiratory tract infection.
Complicated urinary tract infection.
Febrile neutropaenia.
Intra-abdominal and gynaecological (polymicrobial) infections.
Complicated skin and skin structure infections.
Meningitis.
Septicaemia.

4.3 Contraindications

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to meropenem or other carbapenems, penicillins or other beta-lactam antibiotics.

4.4 Special Warnings and Precautions for Use

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, meropenem should be discontinued immediately and an alternative treatment should be considered.

Hypersensitivity reaction (allergic/anaphylaxis).

Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. There have been reports of patients with a history of penicillin hypersensitivity who have experienced severe hypersensitivity when treated with another β-lactam. Before initiating treatment with meropenem, careful enquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, or other β-lactam antibiotics. If an allergic reaction occurs to meropenem then discontinue the drug. Serious hypersensitivity reactions may require adrenaline and other emergency measures.
As with other β-lactam antibiotics, strains of Pseudomonas aeruginosa may develop resistance on treatment with meropenem. Development of resistance has been reported in pseudomonal hospital acquired lower respiratory tract infections. In such cases, meropenem should be used with caution and repeat sensitivity testing is recommended.

Gastrointestinal disease.

History of colitis.

Antibiotics should be prescribed with care for individuals with a history of gastrointestinal disease, especially ulcerative colitis, regional enteritis, or antibiotic associated colitis.

Pseudomembranous colitis.

Pseudomembranous colitis has been observed with practically all antibiotics and may vary in severity from slight to life threatening. Therefore, antibiotics should be prescribed with care for individuals with a history of gastrointestinal complaints, particularly colitis. It is important to consider the diagnosis of pseudomembranous colitis in the case of patients who develop diarrhoea when using an antibiotic. Although studies indicate that a toxin produced by Clostridium difficile is one of the main causes of antibiotic associated colitis, other causes should be considered. Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy such as oral antibacterial agents effective against Clostridium difficile should be considered.
Fluids, electrolytes and protein replacement should be provided when indicated. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.
Seizures have infrequently been reported during treatment with carbapenems, including meropenem.
This medicinal product contains sodium which should be taken into consideration for patients on a controlled sodium diet.

Use in severe meningitis.

Neurological sequelae were reported following treatment of severe meningitis with meropenem. In clinical trials these adverse events were reported in 23 of 148 patients treated with meropenem and in 17 of 144 patients treated with comparator antibiotics.

Use with valproic acid/sodium valproate.

The concomitant use of valproic acid/ sodium valproate and meropenem is not recommended (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in the elderly.

No data available.

Paediatric use.

Efficacy and tolerability in infants under 3 months of age have not been established; therefore, meropenem is not recommended for use below this age.

Effects on laboratory tests.

A positive or indirect Coombs' test may develop.

Use in renal impairment.

See Section 4.2 Dose and Method of Administration.

Use in hepatic impairment.

Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytosis). Patients with preexisting liver disorders should have liver function monitored during treatment with meropenem for injection.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Meropenem has been administered concomitantly with many other medications without apparent adverse interaction. However, no specific medicine interaction studies other than with probenecid were conducted.

Probenecid.

Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem with the effect of increasing the elimination half-life and plasma concentration of meropenem. As the potency and duration of action of meropenem dosed without probenecid are adequate the co-administration of probenecid with meropenem is not recommended. The potential effect of meropenem on the protein binding of other drugs or metabolism has not been studied. However, the protein binding is so low (approximately 2%) that no interactions with other compounds would be expected on the basis of this mechanism.

Valproic acid/ sodium valproate.

A clinically significant reduction in serum valproic acid concentration has been reported when it is co-administered with carbapenem agents resulting in a 60 to 100% decrease in valproic acid levels in about two days. Due to the rapid onset and the extent of the decrease, co-administration of meropenem in patients stabilised on valproic acid/ sodium valproate is not considered to be manageable and therefore should be avoided (see Section 4.4 Special Warnings and Precautions for Use).
The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended.

Oral anticoagulants.

Simultaneous administration of antibiotics with warfarin may augment its anticoagulant effects. There have been many reports of increases in the anticoagulant effects of orally administered anticoagulant agents, including warfarin, in patients who are concomitantly receiving antibacterial agents. The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibiotic to the increase in INR (international normalized ratio) is difficult to assess. It is recommended that the INR should be monitored frequently during and shortly after co-administration of antibiotics with an oral anticoagulant agent.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility was not impaired in rats with exposures (based on AUC) slightly greater than those observed in patients at the recommended intravenous dose.
(Category B2)
Australian categorisation definition of Category B2: drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
Reproduction studies conducted with meropenem in rats have shown no embryotoxicity or teratogenicity at plasma exposures (based on AUC values) approximately equal to those observed in patients at the recommended intravenous dose. In a teratology study in cynomolgus monkeys given daily intravenous injections meropenem showed no evidence of teratogenicity at dose levels up to 360 mg/kg/day.
There are however, no adequate or well controlled trials of meropenem in pregnant women. Because reproduction studies are not always predictive of human response, meropenem should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus.
Meropenem is detectable at very low concentrations in animal breast milk. Meropenem should not be used in breastfeeding women unless the potential benefit justifies the potential risk to the baby.

4.8 Adverse Effects (Undesirable Effects)

Meropenem is generally well tolerated.

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.
In clinical trials, adverse events lead to cessation of treatment in less than 1% of patients. Serious adverse events are rare. See Tables 4 and 5.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Adults.

Usual dose.

500 mg to 1 g by intravenous administration every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient.

Exceptions.

1. Febrile episodes in neutropaenic patients: the dose should be 1 g every 8 hours.
2. Meningitis: the dose should be 2 g every 8 hours.
As with other antibiotics, caution may be required in using meropenem as monotherapy in critically ill patients with known or suspected Pseudomonas aeruginosa lower respiratory tract infection.
Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.
Meropenem Kabi should be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes (see Method of administration section).

Dosage schedule for adults with impaired renal function.

Dosage should be reduced in patients with creatinine clearance less than 51 mL/min, as scheduled in Table 2.
Meropenem is cleared by haemodialysis. If continued treatment with Meropenem Kabi is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations.
There is no experience with peritoneal dialysis.

Use in adults with hepatic insufficiency.

No dosage adjustment is necessary in patients with impaired hepatic metabolism.

Elderly patients.

No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/min.

Children.

For infants and children over 3 months and up to 12 years of age the recommended intravenous dose is 10 to 40 mg/kg every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. In children over 50 kg weight, adult dosage should be used.

Exceptions.

1. Febrile episodes in neutropaenic patients: the dose should be 20 mg/kg every 8 hours.
2. Meningitis: the dose should be 40 mg/kg every 8 hours.
Meropenem Kabi should be given as an IV bolus over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes.
There is no experience in children with renal impairment.

Method of administration.

Meropenem Kabi to be used for bolus intravenous injection should be reconstituted with sterile water for injections (10 mL per 500 mg meropenem). This provides an approximate available concentration of 50 mg/mL. Reconstituted solutions are both clear and colourless to pale yellow.
Meropenem Kabi for intravenous infusion may be directly reconstituted with a compatible infusion fluid and then further diluted (50 to 200 mL) with the compatible infusion fluid.
Shake reconstituted solution before use. All vials are for single use in one patient only. Discard any residue. Standard aseptic technique should be employed during reconstitution and administration.

Compatibility.

Meropenem Kabi is compatible with the following infusion fluids:
0.9% sodium chloride intravenous infusion;
5% or 10% glucose intravenous infusion;
5% glucose intravenous infusion with 0.02% sodium bicarbonate;
0.9% sodium chloride and 5% glucose intravenous infusion;
5% glucose with 0.225% sodium chloride intravenous infusion;
5% glucose with 0.15% potassium chloride intravenous infusion;
2.5% and 10% mannitol intravenous infusion;
normosol-M in 5% glucose intravenous infusion.

Stability.

Meropenem Kabi should not be mixed with or physically added to solutions containing other drugs.
To reduce microbiological hazard, solutions of meropenem should be used as soon as practicable after reconstitution. If storage is necessary, hold at 2 to 8°C for not more than 24 hours, or the period shown in Table 3, whichever is the lesser.
Solutions of Meropenem Kabi should not be frozen.

4.7 Effects on Ability to Drive and Use Machines

No studies on the ability to drive and use machines have been performed. However, when driving or operating machines it should be taken into account that headache, paraesthesiae and convulsions have been reported for meropenem.

4.9 Overdose

The pharmacological properties and mode of administration make it unlikely that intentional overdose will occur. Accidental overdosage could occur during therapy, particularly in patients with renal impairment. Treatment of overdosage should be symptomatic. In normal individuals rapid renal elimination will occur. In subjects with renal impairment haemodialysis will remove meropenem and its metabolite.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium carbonate.

6.2 Incompatibilities

Meropenem Kabi should only be mixed with products listed, see Section 4.2 Dose and Method of Administration.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Prior to reconstitution, store Meropenem Kabi powder for intravenous injection packs below 25°C. See Section 4.2 Dose and Method of Administration for storage of prepared solutions.

6.5 Nature and Contents of Container

Meropenem Kabi Powder for Injection is a white to light yellow powder in clear 20 mL glass vials, closed with bromobutyl rubber closures, sealed with aluminium caps with polypropylene disc (violet for 500 mg and grey for 1 g), containing meropenem trihydrate 570 mg (equivalent to meropenem 500 mg) or meropenem trihydrate 1.14 g (equivalent to meropenem 1.00 g).
Available in packs of 1 or 10 vials.
*Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes