Consumer medicine information

Ertapenem Juno

Ertapenem

BRAND INFORMATION

Brand name

Ertapenem Juno

Active ingredient

Ertapenem

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ertapenem Juno.

Ertapenem Juno

Ertapenem 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 Ertapenem Juno?

Ertapenem Juno contains the active ingredient Ertapenem. Ertapenem Juno is used to treat infections caused by bacteria (germs). These infections include: infections within the abdomen (stomach), pelvic infections, diabetic foot infections in patients without osteomyelitis.

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

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

Do not use if you have ever had an allergic reaction to Ertapenem Juno 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 Ertapenem Juno? in the full CMI.

 3. What if I am taking other medicines?

Some medicines may interfere with Ertapenem 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 Ertapenem Juno?

Ertapenem Juno can be given in two ways:

  • as a slow injection into a vein, known as an intravenous infusion
  • as a deep injection into a large muscle, known as an intramuscular injection.

Ertapenem Juno must only be given by a doctor or nurse.

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

 5. What should I know while using Ertapenem Juno?

Things you should doCall your doctor straight away if you:
  • Develop severe diarrhoea
  • Develop a severe skin reaction such as painful red areas, fluid filed bumps, large blisters, or peeling layers of skin whilst being given Ertapenem Juno
Driving or using machines
  • Ertapenem Juno may cause dizziness or sleepiness in some patients. Make sure you know how you react to Ertapenem Juno before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or sleepy.
Looking after your medicine
  • Ertapenem Juno will usually be stored in the pharmacy or on the ward.
  • The powder for injection should be kept in a cool dry place where the temperature stays below 25°C.

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

 6. Are there any side effects?

Common side effects of Ertapenem Juno include diarrhoea, inflammation of the vein, nausea, and 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.


Ertapenem Juno

Active ingredient(s): ertapenem sodium


 Consumer Medicine Information (CMI)

This leaflet provides important information about using Ertapenem 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 Ertapenem Juno.

Where to find information in this leaflet:

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

1. Why am I using Ertapenem Juno?

Ertapenem Juno contains the active ingredient ertapenem. Ertapenem Juno belongs to a class of antibiotics called carbapenems. It works by killing the bacteria causing your infection.

Ertapenem Juno is used to treat infections caused by bacteria (germs). These infections include:

  • infections within the abdomen (stomach)
  • pelvic infections
  • diabetic foot infections in patients without osteomyelitis

Ertapenem Juno may also be used in patients not responding to, or unable to tolerate, other antibiotics.

Your doctor may have prescribed Ertapenem Juno for another reason.

Ask your doctor if you have any questions about why Ertapenem Juno has been prescribed for you.

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

Warnings

Do not use Ertapenem Juno if:

  • you are allergic to Ertapenem, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • you have an allergy to other antibiotics in the same class as Ertapenem Juno
  • you have had a serious allergic reaction (anaphylaxis) to beta-lactam antibiotics, including penicillins or cephalosporins
  • the vial cap shows signs of tampering
  • the expiry date printed on the pack has passed.

Ertapenem Juno should not be given by injection into a muscle if:

  • you have an allergy to amide-type local anaesthetics, particularly lidocaine (lignocaine)
  • you are in severe shock
  • you have heart block

Check with your doctor if you:

  • have any other medical conditions especially the following
    - seizures or fits, or a predisposition to seizures (eg brain scarring)
    - kidney disease, or are undergoing dialysis
    - bowel problems while using antibiotics or after finishing them, including severe abdominal or stomach cramps, or watery and severe diarrhoea
  • have allergies to other antibiotics, in particular penicillins and cephalosporins.
    - If you are allergic to any of them you may be allergic to Ertapenem Juno.
  • are pregnant or intend to become pregnant
  • are breast-feeding or intend to breast-feed
  • have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
  • are taking a medicine containing valproic acid

If you have not told your doctor about any of the above, tell them before you are given Ertapenem Juno.

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

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

Like most medicines, Ertapenem Juno is generally not recommended during pregnancy. However, if there is a need to consider using Ertapenem Juno during pregnancy, your doctor will discuss the possible risks and benefits to you and your unborn baby.

Breastfeeding

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Like most medicines, the use of Ertapenem Juno is generally not recommended while breast-feeding. Ertapenem Juno is secreted into human milk.

Children

Do not use Ertapenem Juno in children under 3 months of age.

The safety and effectiveness in children younger than 3 months of age have not been established.

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 may interfere with Ertapenem Juno and affect how it works.

  • Sodium valproate, used to control different types of epilepsy and manias.

These medicines may be affected by Ertapenem 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 decide whether you should use Ertapenem Juno in combination with this medicine.

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

4. How do I use Ertapenem Juno?

How it is given

Ertapenem Juno can be given in two ways:

  • as a slow injection into a vein, known as an intravenous infusion
  • as a deep injection into a large muscle, known as an intramuscular injection.

Ertapenem Juno will be prepared and given to you by a doctor or other healthcare professional.

When is it given

  • Your doctor will decide what dose and how long you will receive Ertapenem Juno. This depends on your condition and other factors, such as your kidney function. No dose adjustment is necessary if you are elderly.

If you are given too much Ertapenem Juno

If you think that you have used too much Ertapenem Juno, 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 Ertapenem Juno?

Things you should do

Call your doctor straight away if you:

  • Develop severe diarrhoea

Do this even if it occurs several weeks after Ertapenem Juno has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. This is because antibiotics such as Ertapenem Juno can change the type of bacteria in the bowel. As a result, this allows bacteria, normally present in the bowel and normally harmless, to multiply and cause the above symptoms.

Do not take any diarrhoea medicine without first checking with your doctor.

  • develop a severe skin reaction such as painful red areas, fluid filled bumps, large blisters, or peeling layers of skin whilst being given Ertapenem Juno. You may need urgent medical care.

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

Driving or using machines

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

Ertapenem Juno may cause dizziness or sleepiness in some people.

Looking after your medicine

It is unlikely that you will be asked to store Ertapenem Juno yourself. It will usually be stored in the pharmacy or on the ward.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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.

Common side effects

Common side effectsWhat to do
Tell your doctor or nurse if you notice any of the following and they worry you:
  • discomfort of the vein where you had the injection, for example pain, tenderness, redness, swelling or firm swelling.
  • swelling, clotting, tenderness, swelling and inflammation
  • headache
  • nausea, vomiting
  • diarrhoea
  • vaginal itching or redness
  • alterations in some laboratory blood tests, and a combination of high fever, feeling unwell, and skin rash
Speak to your doctor if you have any of these less serious side effects and they worry you.

These are the more common side effects of Ertapenem Juno. For the most part, these have been mild.

Rare side effects

Rare side effectsWhat to do
Tell your doctor or nurse immediately if you notice any of the following:
  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • high temperature, also called fever
  • seizures or fits
  • shortness of breath
  • chest pain
  • slow heart rate
  • skin rash, redness, itchiness or hives
  • severe skin reactions, such as painful red areas, fluid-filled bumps, large blisters, or peeling of layers of skin have been reported for the beta-lactam class of antibiotics
  • formation of lump and warmth at injection site
  • strange or disturbing thoughts or moods (including agitation, aggression, severe confusion, disorientation, mental status changes)
  • tremors or uncontrollable twitching, jerking or writhing movements
  • decreased consciousness

These may be serious side effects of Ertapenem Juno. You may need urgent medical attention. Serious side effects are rare.

Also, tell your doctor if you notice:
  • dizziness, light-headedness or unsteady walking
  • unusual tiredness or weakness
  • sore, creamy-yellow, raised patches in the mouth (oral thrush)
  • teeth staining
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these rare serious side effects.
Speak to your doctor if you have any of these rare side effects and they worry you.

Very rare side effects

Very rare side effectsWhat to do

A few people may be allergic to some medicines. Tell your doctor or nurse immediately if you notice any of the following. These are examples of acute allergy:

  • throat or chest tightness, difficulty breathing
  • swelling of the mouth, lips, eyes or face
  • flushing (sudden redness) of the face
  • vomiting
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very rare serious side effects.

If you have these, you may have had a serious allergic reaction to Ertapenem Juno. You may need urgent medical attention. These side effects are very rare.

Rare side effects after finished Ertapenem Juno

Rare side effectsWhat to do

Tell your doctor immediately if you notice any of the following y if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Ertapenem Juno:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very rare serious side effects.

These are rare but serious side effects. You may have a serious condition affecting your bowel

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 Ertapenem Juno contains

Active ingredient
(main ingredient)
Ertapenem 1 g
Other ingredients
(inactive ingredients)
sodium bicarbonate
sodium hydroxide

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

What Ertapenem Juno looks like

Ertapenem Juno is a yellowing powder in a glass vial (Aust R 291480).

Who distributes Ertapenem Juno

Juno Pharmaceuticals Pty Ltd
42, Kelso Street, Cremorne, VIC 3121, Australia
www.junopharm.com.au

This leaflet was prepared in May 2022.

Published by MIMS June 2022

BRAND INFORMATION

Brand name

Ertapenem Juno

Active ingredient

Ertapenem

Schedule

S4

 

1 Name of Medicine

Ertapenem sodium.

2 Qualitative and Quantitative Composition

Each vial contains 1.046 grams ertapenem sodium, equivalent to 1 gram ertapenem, and the inactive ingredients sodium bicarbonate and sodium hydroxide. The sodium content is approximately 137 mg (approximately 6.0 mEq).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ertapenem Juno is supplied as a sterile lyophilised powder for intravenous infusion or intramuscular injection containing 1 gram ertapenem as free acid.
Ertapenem Juno is supplied as sterile lyophilized powder for intravenous infusion after reconstitution with appropriate diluent (see Section 4.2 Dose and Method of Administration, Instructions for use) for transfer to 50 mL 0.9% sodium chloride injection or for intramuscular injection following reconstitution with 1% lidocaine (lignocaine) hydrochloride.

4 Clinical Particulars

4.9 Overdose

No specific information is available on the treatment of overdosage with ertapenem. Intentional overdosing of ertapenem is unlikely. Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity. In clinical studies in adults, inadvertent administration of up to 3 g in a day did not result in clinically important adverse experiences. In paediatric clinical studies, a single IV dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.
In the event of an overdose, ertapenem should be discontinued and general supportive treatment given until renal elimination takes place.
Ertapenem can be removed by haemodialysis; however, no information is available on the use of haemodialysis to treat overdosage.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ertapenem was not genotoxic, as assessed in vitro for gene mutations, chromosomal aberrations and DNA strand breaks in cultured mammalian cells. An in vivo assay of chromosomal damage (micronucleus test in mice) was also negative.
Carcinogenicity. The carcinogenic potential of ertapenem has not been examined in long-term animal studies.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ertapenem sodium is a white to off-white hygroscopic, weakly crystalline powder, with a molecular weight of 497.50. It is soluble in water and 0.9% sodium chloride solution, practically insoluble in ethanol, and insoluble in isopropyl acetate and tetrahydrofuran.
Ertapenem Juno (ertapenem sodium) Powder for Injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics, such as penicillins and cephalosporins.
Ertapenem Juno (ertapenem sodium) is chemically described as [4R- [3(3S*,5S*),4α,5β,6β(R*)]] -3-[[5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0] hept-2-ene-2- carboxylic acid monosodium salt.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSERTAPE.gif CAS number. 153773-82-1.
Empirical Formula: C22H24N3O7SNa.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ERTJUNST.gif