What it is and what it is used for

FOR Meropenem contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections. Meropenem is used to treat the following in adults and children aged 3 months and older:

• Infection affecting the lungs (pneumonia)
• Lung and bronchial infections in patients suffering from cystic fibrosis
• Complicated urinary tract infections
• Complicated infections in the abdomen
• Infections that you can catch during or after the delivery
• Complicated skin and soft tissues infections
• Acute bacterial infection of the brain (meningitis) Meropenem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Meropenem may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Meropenem can affect the way some medicines work and some medicines can have an effect on Meropenem. In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem should not be used because it may decrease the effect of sodium valproate.
• Oral anti-coagulant agent (used to treat or prevent blood clots). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is preferable to avoid the use of meropenem during pregnancy. Your doctor will decide whether you should use Meropenem. It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving meropenem. Small amounts of this medicine may pass into the breast milk. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding. Driving and using machines No studies on the effect on the ability to drive and use machines have been performed. Meropenem has been associated with headache and tingling or pricking skin (paraesthesia). Any of these side effects could affect your ability to drive or operate machines. Meropenem may cause involuntary muscle movements which may cause the person's body to shake rapidly and uncontrollably (convulsions). This is usually accompanied with a loss of consciousness. Do not drive or use machines if you experience this side effect. Meropenem contains sodium

What you need to know before you take it

E MEROPENEM Do not use Meropenem if:

• you are allergic (hypersensitive) to meropenem or any of the other ingredients of this medicine (listed in Section 6).

This medicine contains 180.4 mg sodium (main component of cooking/table salt) in each 2 g dose. This is equivalent to 9.0% of the recommended maximum daily dietary intake of sodium for an adult. If you have a condition which requires you to monitor your sodium intake please inform your doctor, pharmacist or nurse.

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3. HOW TO USE MEROPENEM Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Use in adults

• The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need.
• The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose every 8 hours. However you may receive a dose less often if your kidneys do not work very well. Use in children and adolescents
• The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose.

• Swelling of the face, lips, tongue or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
• Serious skin reactions which include o Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
• Severe red scaly rash, skin bumps that contain pus, blisters or peeling of skin, which may be associated with a high fever and joint pains.
• Severe skin rashes that can appear as reddish circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis). Damage to red blood cells (not known) The signs include:
• Being breathless when you do not expect it.
• Red or brown urine.

information on the safety of this medicine.

How to take it

Meropenem

Other possible side effects:

• Meropenem will be given to you as an injection or infusion into a large vein.
• Your doctor or nurse will normally give Meropenem to you.
• However, some patients, parents and carers are trained to give Meropenem at home. Instructions for doing this are provided in this leaflet (in the section called 'Instructions for giving Meropenem to yourself or someone else at home'). Always use Meropenem exactly as your doctor has told you. You should check with your doctor if you are not sure.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem.
• You should normally have your injections at the same times each day.

Common (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Feeling sick (nausea).
• Being sick (vomiting).
• Diarrhoea.
• Headache.
• Skin rash, itchy skin.
• Pain and inflammation.
• Increased numbers of platelets in your blood (shown in a blood test).
• Changes in blood tests, including tests that show how well your liver is working.

If not used immediately in-use storage times and conditions are the responsibility of the user.

If you use more Meropenem than you should

Uncommon (may affect up to 1 in 100 people)

Do not freeze the reconstituted solution.

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

• Changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called 'bilirubin'. Your doctor may do blood tests from time to time.
• Changes in blood tests, including tests that show how well your kidney is working.
• A tingling feeling (pins and needles).
• Infections of the mouth or the vagina that are caused by a fungus (thrush).
• Inflammation of the bowel with diarrhoea.
• Sore veins where Meropenem is injected.
• Other changes in your blood. The symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time.

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.

If you forget to use Meropenem If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not have a double dose (two injections at the same time) to make up for a forgotten dose. If you stop using Meropenem Do not stop having Meropenem until your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Rare (may affect up to 1 in 1,000 people)

4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have any of these signs and symptoms, tell your doctor or nurse straight away. You may need urgent medical treatment. The signs and symptoms may include a sudden onset of:

• Severe rash, itching or hives on the skin.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report

Possible side effects

directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more

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: Meropenem Venus Pharma : Meropenem Venus Pharma : Meropenem Venus : Meropenem : Meropenem Venus Pharma : Meropenem Venus Pharma : Meropenem Venus Pharma

Advice/medical education Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses. 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 causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them. When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working. 1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain. 2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed. 3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours. 4. You should not give antibiotics that were prescribed for you to other people. 5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.

How to store it

MEROPENEM Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month. This medicinal product does not require any special storage condition. Injection After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection should not exceed:

• 3 hours when stored at up to 25°C;
• 12 hours when stored under refrigerated conditions (2-8°C). Infusion

If you notice any of the above, see a doctor straight away.

After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed:

• 3 hours when stored at up to 25°C when Meropenem is dissolved in sodium chloride;
• 24 hours when stored under refrigerated conditions (2-8°C) when Meropenem is dissolved in sodium chloride;
• when Meropenem is dissolved in dextrose the solution should be used immediately.

Contents of the pack and other information

This leaflet was last revised in 06/2022

What Meropenem contains The active substance is meropenem trihydrate equivalent to 2g anhydrous meropenem. The other ingredient is sodium carbonate, anhydrous {E 500 (I)}. What Meropenem looks like and contents of the pack

Marketing Authorisation Holder and Manufacturer Venus Pharma GmbH, Am-Bahnhof 1-3, D59368, Werne, Germany

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The Netherlands Germany Italy United Kingdom Spain France Belgium

Meropenem is a white to slight yellow crystalline powder for solution for injection or infusion in a vial. Pack sizes of 1 vial and 10 vials. Not all pack sizes may be marketed.

• Fits (convulsions).
• Acute disorientation and confusion (delirium). Reporting of side effects

Severe allergic reactions

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.

This medicinal product is authorised in the Member States of the EEA under the following names:

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The following information is intended for medical or healthcare professionals only: Instructions for giving Meropenem to yourself or someone else at home Some patients, parents and carers are trained to give Meropenem 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

• The medicine must be mixed with another liquid (the diluent). Your doctor will tell you how much of the diluent to use.
• Use the medicine straight after preparing it. Do not freeze it.

all the liquid in the vial into the syringe.

Posology

10. Remove the needle and syringe from the vial and throw the empty vial away in a safe place.

The tables below provide general recommendations for dosing.

11. Hold the syringe upright, with the needle pointing upwards. Tap the syringe so that any bubbles in the liquid rise to the top of the syringe. 12. Remove any air in the syringe by gently pushing the plunger until all the air has gone. 13. If you are using Meropenem at home, dispose of any needles and infusion lines that you have used in an appropriate way. If your doctor decides to stop your treatment, dispose of any unused Meropenem in an appropriate way.

1. Wash your hands and dry them very well. Prepare a clean working area.

Giving the injection

2. Remove the Meropenem bottle (vial) from the packaging. Check the vial and the expiry date. Check that the vial is intact and has not been damaged.

You can either give this medicine through a short cannula or venflon, or through a port or central line. Giving Meropenem through a short cannula or venflon

3. Remove the coloured cap and clean the grey rubber stopper with an alcohol wipe. Allow the rubber stopper to dry. 4. Connect a new sterile needle to a new sterile syringe, without touching the ends. 5. Draw up the recommended amount of sterile 'Water for Injections' into the syringe. The amount of liquid that you need is shown in the table below:

Dose of Meropenem

Amount of 'Water for Injections' needed for dilution 500 mg (milligrams) 10 ml (millilitres) 1 g (gram) 20 ml 1.5 g 30 ml 2g 40 ml Please note: If your prescribed dose of Meropenem is more than 1 g, you may use more than 1 vial of Meropenem 500 mg or 1 g or may use one vial of 2 g. You can then draw the liquid in the vials into the one syringe. 6. Put the needle of the syringe through the centre of the grey rubber stopper and inject the recommended amount of Water for Injections into the vial or vials of Meropenem. 7. Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the grey rubber stopper once more with a new alcohol wipe and allow the rubber stopper to dry.

1. Remove the needle from the syringe and throw the needle away carefully in your sharps bin.

The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response. A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. Enterobacterales, Pseudomonas aeruginosa, Acinetobacter spp.), or very severe infections. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). Information on the methods of administration of meropenem in relation with the dose should be considered, in particular, when 2g dose in adults/adolescents or 40 mg/kg dose in children are used (see Method of administration). Adults and Adolescents

2. Wipe the end of the short cannula or venflon with an alcohol wipe and allow it to dry. Open the cap on your cannula and connect the syringe.

Infection

3. Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.

Severe pneumonia including hospital and ventilator-associated pneumonia. Broncho-pulmonary infections in cystic fibrosis Complicated urinary tract infections Complicated intra-abdominal infections Intra- and post-partum infections Complicated skin and soft tissue infections Acute bacterial meningitis Management of febrile neutropenic patients

4. Once you have finished giving the antibiotic and the syringe is empty, remove the 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 1. Remove the cap on the port or line, clean the end of the line with an alcohol wipe and allow it to dry. 2. Connect the syringe and slowly push the plunger on the syringe to give the antibiotic steadily over about 5 minutes. 3. Once you have finished giving the antibiotic, remove the syringe and use a flush as 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.

Dose to be administered every 8 hours 500 mg or 1 g 2g 500 mg or 1 g 500 mg or 1 g 500 mg or 1 g 500 mg or 1 g 2g 1g

Method of administration Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes. Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. Renal impairment

8. With the plunger of the syringe pushed fully into the syringe, put the needle back through the grey rubber stopper. You must then hold both the syringe and the vial and turn the vial upside down.

The following information is intended for healthcare professional only. For full prescribing information please refer to the SmPC.

9. Keeping the end of the needle in the liquid, pull back the plunger and draw

Posology and method of administration

The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. There are limited data to support the administration of these dose adjustments for a unit dose of 2 g.

Creatinine clearance (ml/min) 26-50 10-25 <10

Dose (based on "unit" dose range of 500 mg or 1 g or 2 g, see table above) one unit dose half of one unit dose half of one unit dose

Frequency

every 12 hours every 12 hours every 24 hours

Meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle. There are no established dose recommendations for patients receiving peritoneal dialysis.

30 minutes. Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection. Incompatibilities This medicinal product must not be mixed with other medicinal products. Shelf life 24 months After reconstitution:

Hepatic impairment

Intravenous bolus injection administration

No dose adjustment is necessary in patients with hepatic impairment

A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated for 3 hours at up to 25°C or 12 hours under refrigerated conditions (2-8°C).

Dose in elderly patients No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min. Paediatric population Children under 3 months of age The safety and efficacy of meropenem in children under 3 months of age have not been established and the optimal dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen. Children from 3 months to 11 years of age and up to 50 kg body weight The recommended dose regimens are shown in the table below:

Infection

Severe pneumonia including hospital and ventilatorassociated pneumonia Broncho-pulmonary infections in cystic fibrosis Complicated urinary tract infections Complicated intra-abdominal infections Complicated skin and soft tissue infections Acute bacterial meningitis Management of febrile neutropenic patients

Dose to be administered every 8 hours 10 or 20 mg/kg 40 mg/kg 10 or 20 mg/kg 10 or 20 mg/kg 10 or 20 mg/kg 40 mg/kg 20 mg/kg

Children over 50 kg body weight The adult dose should be administered. There is no experience in children with renal impairment. Method of administration Meropenem is usually given by intravenous infusion over approximately 15 to

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. Intravenous infusion administration A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or 5% dextrose solution for infusion to a final concentration of 1 to 20 mg/ml. Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 3 hours at up to 25°C or 24 hours 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. Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately. The constituted solutions should not be frozen. Special precautions for storage This medicinal product does not require any special storage condition.

Do not freeze the reconstituted solution. Special precautions for disposal and other handling Injection Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. Infusion For intravenous infusion meropenem vials may be directly constituted with 0.9% sodium chloride or 5% dextrose solutions for infusion. Each vial is for single use only. NOTE: The vial should be brought to room temperature before broaching. Standard aseptic techniques should be used for solution preparation and administration. The solution should be shaken before use. Any unused product or waste material should be disposed of in accordance with local requirements.