Consumer medicine information

Meropenem Juno Powder for Injection

Meropenem

BRAND INFORMATION

Brand name

Meropenem Juno

Active ingredient

Meropenem

Schedule

SUMMARY CMI

Meropenem Juno

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Meropenem Juno?

Meropenem Juno contains the active ingredient meropenem. Meropenem Juno is used to treat infections of the lungs (pneumonia or bronchitis), infection of the bladder or kidney (urinary tract infection), infection of tissues around the stomach or gut, infections of the ovaries, vagina or womb, skin infections, infections of the membranes surrounding the brain and spinal cord (meningitis), infections of the blood (septicaemia), high fever and significant reduction in white blood cells resulting decreased resistance to infection (febrile neutropenia).

For more information, see Section 1. Why am I using Meropenem Juno? in the full CMI.

2. What should I know before I use Meropenem Juno?

Do not use if you have ever had an allergic reaction to meropenem or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Meropenem Juno? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Meropenem Juno and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Meropenem Juno?

The dose of Meropenem Juno is based on your condition, age and type and severity of infection.
Your doctor will decide how much Meropenem Juno to give you. The usual dose is 500 mg to 1g injected every 8 hours. If you have meningitis you may require more. If you have kidney problems, a smaller dose may be given. Children also require lower doses.

More instructions can be found in Section 4. How do I use Meropenem Juno? in the full CMI.

5. What should I know while using Meropenem Juno?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using Meropenem Juno. Call you doctor straight away if you develop severe diarrhoea.
Driving or using machines	Meropenem may cause headache, tingling or prickling skin and convulsions/seizures (fits) in some people. If you have any of these symptoms, do not drive, operate machinery or do anything that could be dangerous.
Looking after your medicine	Meropenem Juno is stored below 25°C.

For more information, see Section 5. What should I know while using Meropenem Juno? in the full CMI.

6. Are there any side effects?

Common side effects include pain with redness and/or swelling at the site of injection, feeling sick (nausea), being sick (vomiting), loose stool (diarrhoea), skin problems such as rash or itching, headache.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Meropenem Juno

Active ingredient: meropenem trihydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Meropenem Juno. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Meropenem Juno.

Where to find information in this leaflet:

1. Why am I using Meropenem Juno?
2. What should I know before I use Meropenem Juno?
3. What if I am taking other medicines?
4. How do I use Meropenem Juno?
5. What should I know while using Meropenem Juno?
6. Are there any side effects?
7. Product details

1. Why am I using Meropenem Juno?

Meropenem Juno contains the active ingredient meropenem. Meropenem Juno belongs to a group of medicines called carbapenem antibiotics. These medicines fight bacteria that cause infections in the body. Meropenem will not work against viral (such as colds and flu) or fungal diseases.

Meropenem Juno may have been prescribed to you or your child (aged 3 months or above) for the treatment of the following bacterial infections:

Infections of the lungs (pneumonia or bronchitis)
Infection of the bladder or kidney (urinary tract infection)
Infection of tissues around the stomach or gut
Infections of the ovaries, vagina or womb
Skin infections
Infections of the membranes surrounding the brain and spinal cord (meningitis)
Infections of the blood (septicaemia)
High fever and significant reduction in white blood cells resulting decreased resistance to infection (febrile neutropenia).

Meropenem Juno is given by injection, usually in hospitals, and its available only with a doctor's prescription.

Meropenem Juno is not addictive.

2. What should I know before I use Meropenem Juno?

Warnings

Do not use Meropenem Juno if:

you are allergic to meropenem, or any of the ingredients listed at the end of this leaflet.
you are allergic to other similar antibiotics (e.g. other carbapenems like imipenem; or beta-lactam antibiotics like penicillin, amoxicillin, ampicillin, ceftriaxone, cefotaxime etc).

Symptoms of allergic reaction may include skin rash, itchiness or hives, shortness of breath, wheezing or difficulty breathing, swelling of the face, tongue, lips or other parts of the body.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

have any other medical conditions especially the following
- liver problems
- kidney problems including dialysis
- disease of the stomach or intestines (in particular inflammation of intestine)
Your doctor will discuss with you the benefits and risks of taking it
have allergies to any other medicines, including antibiotics (such as other carbapenems, penicillins, cephalosporins or monobactams).
have allergies to any foods, preservatives or dyes.
are on a controlled sodium diet.
- Meropenem Juno contains sodium (90 mg per 1 g of meropenem.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Do not breast-feed if you are being given this medicine.
The active ingredient in Meropenem Juno passes into the breast milk. Your doctor may discuss the risk and benefits if you need this medicine while you are breast feeding.

Children

Safety and effectiveness of Meropenem Juno in children younger than 3 months of age have not been established. It is not recommended for use in these children.

Ask your doctor if you have any questions about why this medicine has been prescribed for you or your child. Your doctor may have prescribed it for another reason.

3. What if I am taking other medicines?

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

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

Probenecid (a medicine used to treat gout)
Sodium valproate (a medicine used to treat fit/seizure or mania)

These medicines may be affected by Meropenem Juno or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Meropenem Juno.

4. How do I use Meropenem Juno?

How much to take / use

The dose of Meropenem Juno is based on your condition, age and type and severity of infection.

Your doctor will decide how much Meropenem Juno to give you. The usual dose is 500 mg to 1g injected every 8 hours. If you have meningitis you may require more. If you have kidney problems, a smaller dose may be given. Children also require lower doses.

Meropenem Juno should not be given to babies less than three months of age or babies and children with kidney problems.

How Meropenem Juno is given

Meropenem Juno should only be injected into a vein (intravenous injection). It must always be given by a doctor or a nurse. It can be given either as a slow injection or as a slow drip over 15 to 30 minutes.

Your doctor will decide which is best for you.

How long will you be given Meropenem Juno

Meropenem Juno will be given as a number of injections over several days. You doctor will decide how long you will need to have Meropenem Juno.

If you use too much Meropenem Juno

As Meropenem is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you experience any severe side effects after being given Meropenem, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Meropenem Juno?

Things you should do

Call your doctor straight away if you:

Develop severe diarrhoea, even if it occurs several weeks after you have been given Meropenem Juno.

You may have developed a serious bowel condition called antibiotic-associated colitis and you need urgent medical attention. Do not take any medicine for your diarrhoea without checking with your doctor first.

Remind any doctor, dentist or pharmacist you visit that you are using Meropenem Juno.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Meropenem Juno affects you.

Meropenem may cause headache, tingling or prickling skin and convulsions/seizures (fits) in some people. If you have any of these symptoms, do not drive, operate machinery or do anything that could be dangerous. Children should be careful when undertaking activities requiring attention such as riding bicycles or climbing.

If you are about to have any blood tests, tell your doctor that you are being treated with Meropenem Juno.

It may interfere with results of some tests.

Looking after your medicine

The hospital staff will keep Meropenem Juno in a safe place below 25°C. They will also make sure that the expiry date has not passed.

Getting rid of any unwanted medicine

The hospital staff will dispose of any unused Meropenem Juno.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
pain with redness and/or swelling at the site of injection feeling sick (nausea), being sick (vomiting) loose stool (diarrhoea) skin problems such as rash or itching headache	Speak to your doctor if you have any of these less serious side effects and they worry you.

These are common side effects of meropenem and are usually mild and short-lived.

Serious side effects

Serious side effects

What to do

severe diarrhoea, even if it occurs several weeks after you have been given Meropenem Juno
allergic reactions, including shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body; skin rash, itchiness or hives.
chest pain or discomfort
fast or irregular hearbeat; or changes in the rhythm or rate of the heartbeat
convulsions/ seizures (fit)
unexpected breathlessness and/or red/brown urine - this may indicate damage to your red blood cells
muscle discomfort such as swelling, weakness, tender or sore muscles.

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Meropenem Juno contains

Active ingredient (main ingredient)	Meropenem trihydrate
Other ingredients (inactive ingredients)	Sodium carbonate
Potential allergens	NA

Do not take this medicine if you are allergic to any of these ingredients.

What Meropenem Juno looks like

Meropenem Juno 1 g/ vial (Aust R 316981) and 500 mg/ vial (AUST R 316982) is a sterile white to pale yellow powder supplied in a glass vial.

The hospital staff make it up into a solution before injection.

Who distributes Meropenem Juno

Juno Pharmaceuticals Pty Ltd
15-17 Chapel Street,
Cremorne,
VIC 3121
Australia
www.junopharm.com.au

This leaflet was prepared in May 2024.

Published by MIMS August 2024

BRAND INFORMATION

Brand name

Meropenem Juno

Active ingredient

Meropenem

Schedule

1 Name of Medicine

Meropenem, as meropenem trihydrate.

2 Qualitative and Quantitative Composition

See Table 1.

3 Pharmaceutical Form

Meropenem Juno 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 Juno powder for intravenous injection contains 208 mg sodium carbonate for each gram of meropenem (anhydrous potency). It contains no preservative.

4 Clinical Particulars

4.1 Therapeutic Indications

Meropenem Juno 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 (poly microbial) infections;
Complicated skin and skin structure infections;
Meningitis;
Septicaemia.

4.2 Dose and Method of Administration

Treatment.

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 Juno 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 Juno 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 Juno 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 Juno 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 Juno 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 Juno is compatible with the following infusion fluids:
0.9% sodium chloride intravenous infusion;
5% glucose intravenous infusion.

Stability.

Meropenem Juno should not be mixed with or physically added to solutions containing other drugs.
To prevent degradation of the drug product and to reduce microbiological hazard, solutions of meropenem should be administered immediately after preparation. The time interval between the beginning of reconstitution and the end of intravenous injection or infusion should not exceed one hour.
Solutions of Meropenem Juno should not be frozen.

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.
Rhabdomyolysis has been reported with the use of meropenem. If signs or symptoms of rhabdomyolysis are observed, meropenem should be discontinued and appropriate therapy initiated.
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 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 pre-existing liver disorders should have liver function monitored during treatment with meropenem for injection.

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.

Effect on laboratory tests.

A positive or indirect Coombs' test may develop.

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 breast-feeding women unless the potential benefit justifies the potential risk to the baby.

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.

4.8 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 3 and 4.

Description of selected adverse reactions.

Kounis syndrome.

Kounis syndrome (acute coronary syndrome associated with an allergic reaction) has been reported with other beta-lactam antibiotics.

Reporting suspected adverse effects.

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

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 Poisons Information Centre on 13 11 26 (Australia).

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 post-antibiotic 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.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium carbonate.

6.2 Incompatibilities

Meropenem Juno should only be mixed with products listed within 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 Juno 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 Juno 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 in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

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.
Meropenem trihydrate has the following structural formula:

CAS number.

119478-56-7.
Molecular formula of meropenem trihydrate is C₁₇H₂₅N₃O₅S.3H₂O.
Molecular weight: 437.52.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

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Meropenem Juno Powder for Injection

Meropenem

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