Meropenem Hikma
Italy
Table of Contents
Package leaflet: Information for the user
Meropenem Hikma 500 mg powder for injectable solution/infusion, 1 g powder for injectable solution/infusion
Meropenem
Generic medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or nurse. See section 4. Contents of this leaflet:
- What Meropenem Hikma is and what it is used for
- What you need to know before using Meropenem Hikma
- How to use Meropenem Hikma
- Possible side effects
- How to store Meropenem Hikma
- Contents of the pack and other information
1. What Meropenem Hikma is and what it is used for.
Meropenem Hikma belongs to a group of medicines called carbapenem antibiotics.
It works by killing bacteria that can cause serious infections.
- Lung infections (pneumonia)
- Lung and bronchial infections in patients with cystic fibrosis
- Complicated urinary tract infections
- Complicated abdominal infections
- Infections that may occur during or after childbirth
- Complicated skin and soft tissue infections
- Acute bacterial infections of the brain (meningitis)
Meropenem may be used in the management of febrile neutropenic patients when a bacterial infection is suspected.
Meropenem may be used to treat bacterial blood infections that may be associated with one of the above-listed infections.
2. What you need to know before using Meropenem Hikma
Do not use Meropenem Hikma
- If you are allergic to meropenem or to any of the excipients of this medicine (listed in section 6.).
- If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems, you may also be allergic to meropenem.
Warnings and precautions
Tell your doctor or nurse before treatment with Meropenem Hikma:
- If you have any health problems, such as liver or kidney disease.
- If you have previously experienced episodes of severe diarrhoea after taking other antibiotics.
You may develop a positive Coombs test, indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.
Liver problems
If you notice yellowing of the skin or eyes, itching of the skin, dark urine, or pale stools, inform your doctor. These may be signs of liver problems that your doctor needs to investigate.
If you are unsure whether any of the above apply to you, consult your doctor or nurse before using Meropenem Hikma.
Other medicines and Meropenem Hikma
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
This is because Meropenem Hikma may affect the way some medicines work, and conversely, some medicines may affect Meropenem Hikma.
In particular, inform your doctor 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 Hikma must not be used, as it may reduce the effect of sodium valproate.
- Oral anticoagulant agents (used to treat or prevent blood clots).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using meropenem during pregnancy.
It is important that you inform your doctor if you are breastfeeding or intend to breastfeed before receiving meropenem. Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide whether you should use Meropenem Hikma during breastfeeding.
Driving and using machines
No studies have been conducted on the effects of meropenem on the ability to drive vehicles or operate machinery. However, meropenem has been associated with headache; tingling or prickling of the skin (paraesthesia); and involuntary muscle movements leading to rapid, uncontrolled shaking of the body (seizures), usually accompanied by loss of consciousness. Any of these symptoms could affect your ability to drive or operate machinery.
Meropenem Hikma contains sodium
Meropenem Hikma 500 mg: this medicine contains 45 mg of sodium (a main component of table salt) per vial. This amount corresponds to 2.25% of the maximum daily recommended dietary intake of sodium for an adult.
Meropenem Hikma 1 g: this medicine contains 90 mg of sodium (a main component of table salt) per vial. This amount corresponds to 4.5% of the maximum daily recommended dietary intake of sodium for an adult.
If you have a condition that requires sodium intake to be controlled, inform your doctor or nurse.
3. How to use Meropenem Hikma
Always use this medicine exactly as your doctor, pharmacist, or nurse has told you. Ask your doctor, pharmacist, or nurse for advice if you are unsure.
Adults
- The dose depends on the type of infection you have, its location in the body, and its severity. Your doctor will determine the most appropriate dose for you.
- The usual dose for adults ranges from 500 mg (milligrams) to 2 g (grams). A dose is usually given every 8 hours. However, you may receive the dose less frequently if your kidneys are not functioning well.
Children and adolescents
- The dose for children over 3 months of age up to 12 years is determined based on the child's age and body weight. The usual dose ranges from 10 mg to 40 mg of Meropenem Hikma per kilogram (kg) of body weight. A dose is usually given every 8 hours. Children weighing more than 50 kg will receive the same dose as adults.
How to use Meropenem Hikma
- Meropenem Hikma will be administered to you as an injection or infusion into a large vein.
- Your doctor or nurse will normally administer Meropenem Hikma.
- However, some patients, parents, or caregivers have been trained to administer Meropenem Hikma at home. Instructions for administration are provided in this leaflet (in the section 'Instructions for self-administration or administration to others of Meropenem Hikma at home'). Always use Meropenem Hikma exactly as instructed by your doctor. If you have any doubts, consult your doctor.
- Your injection must not be mixed with or added to solutions containing other medicines.
- The injection may be given over approximately 5 minutes or over 15–30 minutes. Your doctor will tell you how Meropenem Hikma should be administered.
- Injections are usually given at the same time each day.
If you use more Meropenem Hikma than you should
If you accidentally use more medicine than prescribed, contact your doctor or the nearest hospital immediately.
If you forget to use Meropenem Hikma
If you miss an injection, take it as soon as possible. However, if it is almost time for the next injection, skip the missed dose.
Do not take a double dose (two injections at the same time) to make up for a forgotten dose.
If you stop using Meropenem Hikma
Do not stop treatment with Meropenem Hikma until your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions
If you have a serious allergic reaction, stop treatment with Meropenem Hikma and contact a doctor immediately. You may need urgent medical care. Signs may include sudden onset of:
- severe rash, itching or hives.
- swelling of the face, lips, tongue or any other part of the body.
- shortness of breath, wheezing or difficulty breathing.
Damage to red blood cells (not known)
Signs include:
- shortness of breath at unexpected times.
- red or brown colouration of urine.
If you notice any of the above signs, contact a doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Abdominal (stomach) pain. Feeling unwell (nausea). Being unwell (vomiting). Diarrhoea. Headache. Rash, itching. Pain and inflammation. Increased platelet count in the blood (detected by a blood test).
- Changes in blood tests, including those indicating liver function.
Uncommon (may affect up to 1 in 100 people)
Changes in blood counts, including reduced platelet count (which may lead to easier bruising), increased number of certain white blood cells, decreased number of other white blood cells, and increased levels of a substance called 'bilirubin'. Your doctor will perform periodic blood tests.
Changes in blood tests, including those indicating kidney function.
Tingling sensation (pins and needles).
Fungal infections of the mouth or vagina (candidiasis).
Inflammation of the intestine with diarrhoea.
Pain in the veins where Meropenem Hikma is injected.
Other blood changes. Symptoms may include frequent infections, high temperature and sore throat. Your doctor may carry out periodic blood tests.
Sudden onset of severe rash, blistering or peeling of the skin. This may be accompanied by high fever and joint pain.
Low potassium levels in the blood (which may cause weakness, muscle cramps, tingling and heart rhythm disturbances).
Liver problems. Yellowing of the skin and eyes, itchy skin, dark urine or pale stools. If you notice any of these signs or symptoms, contact a doctor immediately.
Rare (may affect up to 1 in 1,000 people)
Seizures (convulsions).
Frequency not known (cannot be estimated from the available data)
Severe hypersensitivity reactions including fever, rash, changes in blood tests indicating liver function (increased liver enzyme levels), increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as DRESS syndrome.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Meropenem Hikma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Injection
After reconstitution
Reconstituted solutions for intravenous injection must be used immediately.
The time interval between the start of reconstitution and the end of intravenous injection must not exceed:
- 3 hours when stored below 25°C
- 12 hours when stored under refrigerated conditions (2-8°C)
Infusion
After reconstitution: Reconstituted solutions for intravenous infusion must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed:
- 3 hours when stored below 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 must be used immediately.
From a microbiological standpoint, the product should be used immediately unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination.
If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.
Do not freeze the reconstituted solution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These precautions will help protect the environment.
6. Package contents and other information
What Meropenem Hikma contains
Each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.
Each vial contains meropenem trihydrate equivalent to 1 g of anhydrous meropenem.
The other excipient is anhydrous sodium carbonate.
Description of the appearance of Meropenem Hikma and contents of the pack
Meropenem is a white to pale yellow powder for injectable or infusion solution in a glass vial with a rubber stopper and an aluminium flip-off seal.
Pack sizes
Packs containing 1 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A and 8B, Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer:
ACS Dobfar S.p.A
Nucleo Industriale S. Atto
S. Nicolò a Tordino
64100 TERAMO
Italy
Selling Agent for Italy
Hikma Italia SpA
Viale Certosa 10, 27100 Pavia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Meropenem Hikma 500mg Powder for solution for injection/infusion
Meropenem Hikma 1g Powder for solution for injection/infusion
Ireland: Meropenem 500mg Powder for solution for injection/infusion
Meropenem 1g Powder for solution for injection/infusion
Italy: Meropenem Hikma 500mg Powder for solution for injection/infusion
Meropenem Hikma 1g Powder for solution for injection/infusion
Germany: Meropenem Hikma 500mg Powder for solution for injection/infusion
Meropenem Hikma 1g Powder for solution for injection/infusion
| Meropenem Hikma 1g Powder for the preparation of an injection/ | |
| infusion solution | |
Portugal: Meropenem Hikma 500mg Powder for solution for injection or infusion
Meropenem Hikma 1g Powder for solution for injection or infusion
Netherlands: Meropenem Hikma 500mg Powder for solution for injection for
infusion
Meropenem Hikma 1g Powder for solution for injection for infusion
United Kingdom: Meropenem 500mg Powder for solution for injection/infusion
Meropenem 1g Powder for solution for injection/infusion
Spain: Meropenem Hikma 500mg Powder for injection solution and for
perfusion EFG
| Meropenem Hikma 1g Powder for injectable solution and for infusion | |
| EFG | G |
France: Meropenem Hikma 500mg Powder for solution for injection/infusion
Meropenem Hikma 1g Powder for solution for injection/infusion
This leaflet was last reviewed on 01/2026
Medical notice/instructions
Antibiotics are used to treat infections caused by bacteria. They are not effective against infections caused by viruses.
Sometimes, a bacterial infection does not respond to a course of antibiotic therapy. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic 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 correctly may help reduce the likelihood of bacteria becoming resistant.
When your doctor prescribes you a course of antibiotic treatment, it is intended solely for the treatment of your current illness. Paying attention to the following advice will help you prevent the development of bacterial resistance, which could stop the antibiotic from working.
- It is very important that you take the correct dose of antibiotic, at the correct times, and for the correct number of days. Read the instructions in this leaflet and, if you do not understand anything, ask your doctor or pharmacist for clarification.
- You must not take the antibiotic unless it has been specifically prescribed for you, and you should use it only to treat the infection for which it was prescribed.
- Do not take antibiotics that have been prescribed for other people, even if they have an infection similar to yours.
- Do not give antibiotics prescribed for you to other people.
- If you have leftover antibiotics after completing the course prescribed by your doctor, return them to a pharmacist for proper disposal.
The following information is intended exclusively for healthcare professionals.
The following paragraphs provide practical information on the preparation and administration
of this medicinal product. Once the appropriateness of use in a specific patient has been established, the prescriber must be familiar with the Summary of Product Characteristics
for this medicinal product. See also section 3, 'How to use Meropenem', in this leaflet.
Instructions for self-administration or administration to others at home
of Meropenem Hikma
Some patients, parents or caregivers have been trained in the administration of Meropenem
Hikma at home.
Caution – This medicinal product may be self-administered or administered to others at home only after receiving appropriate training from a physician or nurse.
- The medicinal product must be mixed with another liquid (the solvent). Your doctor will tell you how much solvent to use.
- Use the medicinal product immediately after preparation. Do not freeze it.
How to prepare this medicinal product
- Wash and dry your hands thoroughly. Prepare a clean work area.
- Remove the Meropenem Hikma vial from its packaging. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
- Remove the colored cap and clean the grey rubber stopper with alcohol. Allow the rubber stopper to dry.
- Insert a new sterile needle into a new sterile syringe, taking care not to touch the tips.
- Draw up the recommended amount of sterile 'Water for Injections' into the syringe. The required volume of liquid is indicated in the following table.
| Dose of Meropenem Hikma | Amount of 'water for injections' required for dilution |
| 500 mg (milligrams) | 10 ml (millilitres) |
| 1 g (gram) | 20 ml |
| 1.5 g | 30 ml |
| 2 g | 40 ml |
Note: If the prescribed dose of Meropenem Hikma exceeds 1 g, you will need to use more than one vial of Meropenem Hikma. You may then withdraw the liquid and transfer it into a syringe.
- Insert the needle attached to the syringe into the centre of the grey rubber stopper and inject the recommended amount of water for injections into the Meropenem Hikma vial or vials.
- Remove the needle from the vial and shake the vial well for about 5 seconds, or until the powder is completely dissolved. Clean the grey rubber stopper again with alcohol and allow the grey rubber stopper to dry.
- With the plunger fully inserted inside the syringe, reattach the needle to the top of the grey rubber stopper. Hold both the syringe and the vial firmly in your hands, then turn the vial upside down.
- Keep the tip of the needle immersed in the liquid, pull back the plunger of the syringe and withdraw all the liquid from the vial into the syringe.
- Remove the needle and syringe from the vial and dispose of the empty vial safely.
- Hold the syringe upright with the needle tip pointing upwards. Tap the syringe gently so that any air bubbles rise to the surface.
- Remove any air in the syringe by gently pushing the plunger until all air is expelled.
- If you are using Meropenem Hikma at home, dispose of used needles and infusion lines appropriately. If your doctor decides to discontinue treatment, dispose of any unused Meropenem Hikma appropriately.
How to administer the injection
This medicine may also be administered through a small cannula or venflon, or via a port-type catheter or central infusion line.
Administration of Meropenem Hikma via a small cannula or venflon
- Remove the needle from the syringe and carefully dispose of the needle in a sharps container.
- Wipe the tip of the small cannula or venflon with alcohol and allow it to dry. Open the cap of the cannula and connect it to the syringe.
- Slowly push the plunger of the syringe to administer the antibiotic steadily over approximately 5 minutes.
- Once the antibiotic has been administered and the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
- Replace the cap on the cannula and carefully dispose of the syringe in a sharps container.
Administration of Meropenem Hikma via port-type catheter or central
infusion line
- Remove the cap from the port or line, clean the end of the line with alcohol and allow it to dry.
- Attach the syringe and slowly push the plunger to administer the antibiotic steadily over approximately 5 minutes.
- After completing administration of the antibiotic, remove the syringe and flush as recommended by your doctor or nurse.
- Attach a new, clean cap to the central infusion line and carefully dispose of the syringe in a sharps container.
Administration of Meropenem by intravenous infusion
Meropenem may be administered by intravenous infusion over approximately 15–30 minutes. For intravenous infusion, Meropenem Hikma vials may be reconstituted to a final concentration of 1 to 20 mg/ml directly with either 0.9% sodium chloride solution or 5% glucose solution for infusion.
The solution should be shaken before use.
Each vial is for single use only.
Package leaflet: information for the user
Meropenem Hikma 2 g powder for solution for injection/infusion
Meropenem
Generic medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse. See section 4. Contents of this leaflet:
- What Meropenem Hikma is and what it is used for
- What you need to know before using Meropenem Hikma
- How to use Meropenem Hikma
- Possible side effects
- How to store Meropenem Hikma
- Contents of the pack and other information
1. What Meropenem Hikma is and what it is used for.
Meropenem Hikma contains the active substance meropenem and belongs to a group of medicines
called carbapenem antibiotics.
It works by killing bacteria that can cause serious infections.
Meropenem Hikma is used in adults and children over three months of age to treat the
following infections:
- Lung infections (pneumonia)
- Lung and bronchial infections in patients with cystic fibrosis
- Complicated urinary tract infections
- Complicated intra-abdominal infections
- Infections that may occur during or after childbirth
- Complicated skin and soft tissue infections
- Acute bacterial infections of the brain (meningitis)
Meropenem may be used in the management of neutropenic patients (patients with low levels
of certain white blood cells called neutrophils) who have fever suspected to be due to
a bacterial infection.
Meropenem may be used to treat bacterial blood infections that may be associated with one of the
above-mentioned infections.
2. What you need to know before using Meropenem Hikma
Do not use Meropenem Hikma
- If you are allergic to meropenem or to any of the excipients of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems, you may also be allergic to meropenem.
Warnings and precautions
Tell your doctor or nurse before treatment with Meropenem Hikma:
- If you have any health problems, such as liver or kidney disease.
- If you have previously experienced episodes of severe diarrhoea after taking other antibiotics.
You may develop a positive test (Coombs test) indicating the presence of antibodies that can
destroy red blood cells. Your doctor will discuss this with you.
You may develop signs and symptoms of serious skin reactions (see section 4). If this occurs, inform
your doctor or nurse immediately so that your symptoms can be treated.
Liver problems
If you notice yellowing of the skin or eyes, skin itching, dark urine, or pale stools,
inform your doctor. These could be signs of liver problems that your doctor needs to
investigate.
If you are unsure whether any of the above apply to you, consult your doctor or nurse before
using Meropenem Hikma.
Other medicines and Meropenem Hikma
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take
any other medicines.
This is because Meropenem Hikma may affect the way some medicines work, and conversely, some medicines may affect Meropenem Hikma.
In particular, inform your doctor 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 Hikma must not be used because it may reduce the effect of sodium valproate.
- Oral anticoagulants (used to treat or prevent blood clots).
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult
your doctor or pharmacist before taking this medicine.
It is preferable to avoid using meropenem during pregnancy. Your doctor will decide whether you
should use meropenem.
It is important that you inform your doctor if you are breastfeeding or intend to breastfeed before
receiving meropenem. Small amounts of this medicine may pass into breast milk.
Therefore, your doctor will decide whether you should use Meropenem Hikma during breastfeeding.
Driving and using machines
No studies have been conducted on the effect on the ability to drive or use machines. However, meropenem has been associated with headache; tingling or prickling of the skin (paraesthesia); and involuntary muscle movements causing the body to shake rapidly and uncontrollably (seizures), which are usually accompanied by loss of consciousness. Any of these symptoms could affect your ability to drive or use machines. If you experience any of these side effects, do not drive or operate machinery.
Meropenem Hikma contains sodium
This medicine contains 180 mg of sodium (a key component of table salt) in each 2 g dose. This amount is equivalent to 9.0% of the maximum recommended daily dietary intake of sodium for an adult.
If you have a condition that requires you to control your sodium intake, inform your doctor or
nurse.
3. How to use Meropenem Hikma
Always use this medicine exactly as your doctor, pharmacist, or nurse has told you. Ask for advice from your doctor, pharmacist, or nurse if you are unsure.
Adults
- The dose depends on the type of infection you have, its location in the body, and its severity. Your doctor will determine the most appropriate dose for you.
- The usual dose for adults ranges from 500 mg (milligrams) to 2 g (grams). It is generally given every 8 hours. However, you may receive the dose less frequently if your kidneys are not functioning well.
Children and adolescents
- The dose for children over 3 months of age and up to 12 years of age is determined based on the child's age and weight. The usual dose ranges from 10 mg to 40 mg of Meropenem Hikma per kilogram (kg) of the child’s body weight. A dose is usually given every 8 hours. Children weighing more than 50 kg will receive the same dose as adults.
How to use Meropenem Hikma
- Meropenem Hikma will be administered to you as an injection or infusion into a large vein.
- Your doctor or nurse will normally administer Meropenem Hikma.
- However, some patients, parents, or caregivers may have been trained to administer Meropenem Hikma at home. Instructions for administration are provided in this leaflet (in the section ‘Instructions for self-administration or administration to others of Meropenem Hikma at home’). Always use Meropenem Hikma exactly as instructed by your doctor. If you have any doubts, consult your doctor.
- Your injection must not be mixed with or added to solutions containing other medicines.
- The injection may be given over approximately 5 minutes or over 15–30 minutes. Your doctor will tell you how Meropenem Hikma should be administered.
- Injections are usually given at the same time each day.
If you use more Meropenem Hikma than you should
If you accidentally take more medicine than prescribed, contact your doctor or the nearest hospital immediately.
If you forget to use Meropenem Hikma
If you miss an injection, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose (two injections at the same time) to make up for a forgotten dose.
If you stop treatment with Meropenem Hikma
Do not stop treatment with Meropenem Hikma unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor or nurse.
4. Possible side effects
Like all medicines, this drug can cause side effects, although not everyone experiences them.
Serious allergic reactions
If you have a severe allergic reaction, stop treatment with Meropenem Hikma and consult a doctor immediately. You may require urgent medical care. Signs may include sudden onset of:
- severe skin rash, itching or hives.
- swelling of the face, lips, tongue or any other part of the body.
- shortness of breath, wheezing or difficulty breathing, including:
o Severe hypersensitivity reactions including fever, rash, changes in blood tests monitoring liver function (increased liver enzyme levels), an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as DRESS syndrome.
o Severe red, scaly skin rash, skin lesions containing pus, blisters, skin peeling, which may be associated with high fever and joint pain.
o Severe skin rashes that may appear as circular red spots often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).
Damage to red blood cells (frequency not known)
Signs include:
- sudden shortness of breath.
- red or brown discoloration of urine. If you notice any of the above signs, consult a doctor immediately.
Other possible side effects:
Common (occurs in 1 out of 10 people)
- Abdominal pain (stomach). Feeling unwell (nausea). Malaise (vomiting). Diarrhea. Headache. Skin rash, itching. Pain and inflammation. Increased platelet count in blood (detected by blood test).
- Changes in blood tests, including those assessing liver function.
Uncommon (occurs in 1 out of 100 people)
Changes in blood tests, including decreased platelet count (which may lead to easier bruising), increased number of certain white blood cells, decreased number of other white blood cells, and increased levels of a substance called 'bilirubin'. Your doctor will periodically perform blood tests.
Changes in blood tests, including those indicating kidney function.
Tingling sensation (pins and needles).
Fungal infections of the mouth or vagina (candidiasis).
Inflammation of the intestine with diarrhea.
Pain in the veins where Meropenem Hikma is injected.
Other blood changes. Symptoms may include frequent infections, high temperature, and sore throat. Your doctor may perform periodic blood tests.
Low potassium levels in blood (which may cause weakness, muscle cramps, tingling, and heart rhythm disturbances).
Liver problems. Yellowing of the skin and eyes, itchy skin, dark-colored urine or pale stools. If you notice these signs or symptoms, consult a doctor immediately.
Rare (occurs in 1 out of 1000 people)
Seizures (convulsions).
Acute disorientation and confusion (delirium).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Meropenem Hikma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial. The expiry date refers to the last day of the month.
Do not store above 30°C.
Injection
After reconstitution:
Reconstituted solutions for intravenous injection must be used immediately.
The time interval between the start of reconstitution and the end of intravenous injection must not exceed:
- 3 hours when stored below 25°C
- 12 hours when stored under refrigerated conditions (2–8°C)
Limited safety data are available to support administration of a 2 g dose in adults as an intravenous bolus injection.
After reconstitution, the solution should be colourless to pale yellow.
Infusion
After reconstitution: Reconstituted solutions for intravenous infusion must be used immediately. The time interval between the start of reconstitution and the end of intravenous infusion must not exceed:
- 3 hours when stored below 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 must be used immediately.
From a microbiological point of view, the product should be used immediately unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination.
If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.
Do not freeze the reconstituted solution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These precautions will help protect the environment.
6. Package contents and other information
What Meropenem Hikma contains
Each vial contains meropenem trihydrate equivalent to 2 g of anhydrous meropenem.
The other excipient is anhydrous sodium carbonate.
Description of the appearance of Meropenem Hikma and contents of the pack
Meropenem is a white to pale yellow crystalline powder for injectable solution or infusion in a glass vial with a rubber stopper and aluminium flip-off seal.
Pack sizes
Packs containing 1, 6 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, nº8, 8A and 8B, Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer:
ACS Dobfar S.p.A
Nucleo Industriale S. Atto
S. Nicolò a Tordino
64100 TERAMO
Italy
Marketing Authorization Holder for Italy
Hikma Italia SpA
Viale Certosa 10, 27100 Pavia
This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Meropenem Hikma 2 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
Ireland: Meropenem 2 g Powder for solution for injection/infusion
Italy: Meropenem Hikma 2 g Polvere per soluzione iniettabile o infusione
Germany: Meropenem Hikma 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Portugal: Meropenem Hikma 2 g Pó para solução injetável ou para perfusão
The Netherlands: Meropenem Hikma 2 g Poeder voor oplossing injectie voor infusie
United Kingdom: Meropenem 2 g Powder for solution for injection/infusion
Spain: Meropenem Hikma 2 g Polvo para solución inyectable y para perfusion
EFG
France: Meropenem Hikma 2 g Poudre pour solution injectable/pour perfusion
This Patient Information Leaflet was last revised in 01/2026
Medical notice/instructions
Antibiotics are used to treat infections caused by bacteria. They are not effective against infections caused by viruses.
Sometimes, a bacterial infection does not respond to a course of antibiotic therapy. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic 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 correctly can help reduce the likelihood of bacteria becoming resistant.
When your doctor prescribes you a course of antibiotic therapy, it is intended solely for the treatment of your current illness. Paying attention to the following advice will help you prevent the development of bacterial resistance, which can stop the antibiotic from working.
- It is very important that you take the correct dose of antibiotic, at the right times and for the correct number of days. Read the instructions in the leaflet and, if you do not understand something, ask your doctor or pharmacist for clarification.
- You should not take antibiotics unless they have been specifically prescribed for you, and you should use them only to treat the infection for which they were prescribed.
- Do not take antibiotics that have been prescribed for other people, even if they have an infection similar to yours.
- Do not give antibiotics prescribed for you to other people.
- If you have leftover antibiotics after completing the course prescribed by your doctor, return them to a pharmacist for proper disposal.
The following information is intended exclusively for healthcare professionals.
The following paragraphs contain practical information on the preparation and administration
of this medicinal product. Once the appropriateness of use in a specific patient has been established, the prescribing physician must refer to the Summary of Product Characteristics
for this medicinal product. See also section 3, 'How to use Meropenem', in this leaflet.
Instructions for self-administration or administration to others at home
of Meropenem Hikma
Some patients, parents or caregivers have been trained in the administration of Meropenem
Hikma at home.
Caution – This medicine may be self-administered or administered to others at home only after appropriate training provided by a physician or nurse.
- The medicine must be mixed with another liquid (the solvent). Your doctor will tell you how much solvent to use.
- Use the medicine immediately after preparation. Do not freeze it.
How to prepare this medicine
- Wash and dry your hands thoroughly. Prepare a clean work area.
- Remove the Meropenem Hikma container (vial) from its packaging. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
- Remove the colored cap and clean the grey rubber stopper with alcohol. Allow the rubber stopper to dry.
- Attach a new sterile needle to a new sterile syringe, taking care not to touch the tips.
- Draw up the recommended volume of sterile 'Water for Injections' into the syringe. The required volume of liquid is indicated in the following table.
| Dose of Meropenem Hikma | Volume of ‘water for injections’ required for dilution |
| 500 mg (milligrams) | 10 ml (milliliters) |
| 1 g (gram) | 20 ml |
| 1.5 g | 30 ml |
| 2 g | 40 ml |
Note: If the prescribed dose of Meropenem Hikma exceeds 1 g, you will need to use more than one vial of Meropenem Hikma 500 mg or 1 g, or you will need to use one 2 g vial. You may then withdraw the liquid and transfer it into a syringe.
- Insert the needle attached to the syringe into the centre of the grey rubber stopper and inject the recommended amount of water for injections into the Meropenem Hikma vial or vials.
- Remove the needle from the vial and shake the vial well for about 5 seconds, or until the powder is completely dissolved. Clean the grey rubber stopper again with alcohol and allow the grey rubber stopper to dry.
- With the plunger fully inserted inside the syringe, reattach the needle to the top of the grey rubber stopper. Hold both the syringe and the vial in your hand, then invert the vial.
- Keep the tip of the needle immersed in the liquid, pull back the syringe plunger and withdraw all the liquid from the vial into the syringe.
- Remove the needle and syringe from the vial and dispose of the empty vial safely.
- Hold the syringe upright with the needle tip pointing upwards. Tap the syringe gently so that any air bubbles rise to the surface.
- Remove any air in the syringe by gently pushing the plunger until all air is expelled.
- If you are using Meropenem Hikma at home, dispose of used needles and infusion lines appropriately. If your doctor decides to discontinue treatment, dispose of any unused Meropenem Hikma appropriately.
How to administer the injection
This medicine may also be administered through a small cannula or venflon, or via a port-type catheter or central infusion line.
Meropenem is generally administered by intravenous infusion lasting approximately 15–30 minutes.
Alternatively, doses up to 1 g may be given as an intravenous bolus injection over approximately 5 minutes. Limited safety data are available to support administration of a 2 g dose in adults as an intravenous bolus injection.
Administration of Meropenem Hikma via a small cannula or venflon
- Remove the needle from the syringe and carefully dispose of the needle in a sharps container.
- Wipe the tip of the small cannula or venflon with alcohol and allow it to dry. Open the cap of the cannula and connect it to the syringe.
- Slowly push the syringe plunger to administer the antibiotic steadily over approximately 5 minutes.
- Once the antibiotic has been administered and the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
- Cap the cannula and carefully dispose of the syringe in a sharps container.
Administration of Meropenem Hikma via port-type catheter or central
infusion line
- Remove the cap from the port or line, clean the end of the line with alcohol and allow it to dry.
- Attach the syringe and slowly push the plunger to administer the antibiotic steadily over approximately 5 minutes.
- After administration of the antibiotic is complete, remove the syringe and flush as recommended by your doctor or nurse.
- Attach a new sterile cap to the central infusion line and carefully dispose of the syringe in a sharps container.
Administration of Meropenem by intravenous infusion
Meropenem may be administered by intravenous infusion over approximately 15–30 minutes. For intravenous infusion, Meropenem Hikma vials may be reconstituted to a final concentration ranging from 1 to 20 mg/ml directly with either 0.9% sodium chloride solution or 5% glucose solution for infusion.
The solution should be shaken before use.
Each vial is for single use only.