Meropenem Acs Dobfar

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meropenem ACS Dobfar 500 mg powder for injectable solution / for infusion, 1 g powder for injectable solution / for infusion

Read this leaflet carefully before taking 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be dangerous.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Meropenem ACS Dobfar is and what it is used for

2. What you need to know before using Meropenem ACS Dobfar

3. How to use Meropenem ACS Dobfar

4. Possible side effects

5. How to store Meropenem ACS Dobfar

6. Contents of the pack and other information

7. What Meropenem ACS Dobfar is and what it is used for

Meropenem ACS Dobfar 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 is used to treat the following conditions in adults and children aged three months and older:

• Lung infections (pneumonia)
• Lung and bronchial infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal (stomach) infections
• Infections that may occur during or after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infections of the brain (meningitis)

Meropenem ACS Dobfar may be used to treat patients who are neutropenic (patients with low levels of white blood cells) and who have fever suspected to be due to a bacterial infection.
Meropenem ACS Dobfar may also be used to treat bacterial blood infections that may be associated with one of the above-mentioned types of infection.

2. What you need to know before using Meropenem ACS Dobfar

Do not use Meropenem ACS Dobfar if:

• you are allergic (hypersensitive) to meropenem or to any of the ingredients of this medicine (listed in section 6).
• you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems; you may also be allergic to meropenem.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Meropenem ACS Dobfar if:

• you have health problems, such as diseases of the liver or kidneys.
• you have 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, speak immediately with your doctor or nurse so they can treat the symptoms.
If you notice unexplained muscle pain, tenderness or weakness, and/or dark-coloured urine, inform your doctor immediately. This could be a sign of muscle breakdown (called rhabdomyolysis), which may lead to kidney problems.
If you are unsure whether any of the above applies to you, consult your doctor or nurse before using Meropenem ACS Dobfar.
Liver problems
Inform your doctor if you notice yellowing of the skin or eyes, itching of the skin, dark-coloured urine, or pale-coloured stools. These could be signs of a liver problem, which your doctor will need to investigate.
Other medicines and Meropenem ACS Dobfar
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Meropenem ACS Dobfar may affect the action of certain medicines, and conversely, some medicines may affect Meropenem ACS Dobfar.
In particular, inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Probenecid (used to treat gout).
• Valproic acid/valproate sodium/valpromide (used to treat epilepsy). Meropenem ACS Dobfar must not be used, as it may reduce the effect of valproate sodium.
• Oral anticoagulants (used to treat or prevent blood clots).

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor before using this medicine.
It is preferable to avoid taking meropenem during pregnancy. Your doctor will decide whether you should use Meropenem ACS Dobfar.
It is important that you inform your doctor if you are breast-feeding or intend to breast-feed before taking meropenem. Small amounts of this medicine pass into breast milk. Therefore, your doctor will decide whether you should use Meropenem ACS Dobfar during breast-feeding.
Driving and using machines
No studies have been conducted on the effect on the ability to drive vehicles or use machinery.
However, Meropenem ACS Dobfar has been associated with headache; tingling or prickling sensation of the skin (paresthesia). Any of these side effects may affect your ability to drive or use machinery. Meropenem ACS Dobfar may cause involuntary muscle movements leading to rapid and uncontrolled body movements (convulsions). These are usually accompanied by loss of consciousness. Do not drive or operate machinery if you experience this adverse effect.
Meropenem ACS Dobfar contains sodium
Meropenem ACS Dobfar 500 mg: this medicine contains 45 mg of sodium (the main component of table salt or cooking salt) in each 500 mg dose, equivalent to 2.25% of the maximum daily recommended sodium intake for an adult.
Meropenem ACS Dobfar 1 g: this medicine contains 90 mg of sodium (the main component of table salt or cooking salt) in each 1 g dose, equivalent to 4.5% of the maximum daily recommended sodium intake for an adult.
If you have a condition that requires you to control your sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem ACS Dobfar

Use this medicine exactly as prescribed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Use in adults

• The dose depends on the type of infection you have, its location in the body, and its severity. Your doctor will decide the most appropriate dose for you.
• The usual dose for adults ranges from 500 mg (milligrams) to 2 g (grams). You usually receive a dose every 8 hours. However, you may receive the dose less frequently if your kidneys are not functioning properly.

Use in children and adolescents

• The dose for children over 3 months of age 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 ACS Dobfar per kilogram (kg) of the child’s body weight. A dose is usually administered every 8 hours. Children weighing more than 50 kg will receive the adult dosage.

How to use Meropenem ACS Dobfar

• Meropenem ACS Dobfar will be administered to you as an injection or infusion into a large vein.
• Normally, your doctor or nurse will administer Meropenem ACS Dobfar to you.
• However, some patients, parents, or caregivers have been trained to administer Meropenem ACS Dobfar at home. Instructions for administration are provided in this leaflet (in the section titled “Instructions for self-administration or administration to others of Meropenem ACS Dobfar at home”). Always use Meropenem ACS Dobfar exactly as directed by your doctor. If you have any doubts, always consult your doctor.
• Your injection must not be mixed or added to solutions containing other medicines.
• The injection may be given over approximately 5 minutes or over 15–30 minutes. Your doctor will instruct you on how to administer Meropenem ACS Dobfar.
• Injections are usually given at the same time each day.

If you use more Meropenem ACS Dobfar than you should
If you accidentally take more than the prescribed amount, inform your doctor immediately or go to the nearest hospital emergency department.

If you forget to use Meropenem ACS Dobfar
If you miss an injection, take it as soon as possible. However, if it is almost time for your 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 using Meropenem ACS Dobfar
Do not stop treatment with Meropenem ACS Dobfar until your doctor tells you it is safe to do so.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Severe allergic reactions
If you experience any of the following signs or symptoms, inform your doctor or nurse immediately.
You may require urgent medical treatment. Signs and symptoms of these allergic reactions include sudden onset of:

• Severe skin rash, itching or hives.
• Swelling of the face, lips, tongue or other parts of the body.
• Shortness of breath, wheezing or difficulty breathing.
• Severe skin reactions that include:
  o Severe hypersensitivity reactions including fever, skin rash, changes in blood tests showing how well the liver is working (increased liver enzyme levels), an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes. These may be signs of a multi-organ hypersensitivity disorder known as DRESS syndrome.
  o Severe red, scaly skin rash, pus-filled blisters, skin blistering or peeling, which may be associated with high fever and joint pain.
  o Severe skin reactions that may appear as red, circular patches, often with central blisters on the trunk, skin shedding, mouth ulcers, and ulcers in the throat, nose, genitals and eyes, 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 (unknown frequency)
Signs include:

• Shortness of breath during unexpected physical activity.
• Red or brown discoloration of urine. If you notice any of the above signs, seek immediate medical advice.

Muscle breakdown

• Unexplained muscle pain, tenderness or weakness, and/or dark-colored urine. If you notice these signs or symptoms, consult a doctor immediately.

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Abdominal pain (stomach).
• Feeling unwell (nausea).
• Being unwell (vomiting).
• Diarrhea.
• Headache.
• Skin rash, itchy skin.
• Pain and inflammation.
• Increased number of platelets in the blood (detected by blood test).
• Changes in blood tests, including those showing liver function.

Uncommon (may affect up to 1 in 100 people)

• Blood disorders, including reduced number of platelets (which may cause easier bruising), increased number of certain white blood cells, reduced number of other white blood cells, and increased levels of a substance called 'bilirubin'. Your doctor will periodically perform blood tests for you.

• Changes in blood tests, including those indicating how well your kidneys are working.

• Low potassium levels in the blood (which may cause weakness, muscle cramps, tingling sensations, and heart rhythm disturbances).

• Liver problems. Yellowing of the skin and eyes, itchy skin, dark urine or pale stools. If you notice these signs or symptoms, consult a doctor immediately.

• Tingling sensation (pins and needles).

• Mouth or vaginal fungal infections (candidiasis).

• Intestinal inflammation with diarrhea.

• Pain in the veins at the injection site when Meropenem ACS Dobfar is administered.

• Other blood abnormalities. Symptoms include frequent infections, high temperature and sore throat. Your doctor will periodically perform blood tests for you.

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

• Seizures.
• Acute confusion and seizures (delirium).

Sudden chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome, has been observed with other medicines of the same class. If this occurs, seek immediate medical advice from a doctor or nurse.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 ACS Dobfar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "Exp:".
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 if stored at temperatures up to 25°C;
• 12 hours if stored in the refrigerator (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 if stored at temperatures up to 25°C when Meropenem ACS Dobfar is dissolved in sodium chloride;
• 24 hours if stored in the refrigerator (2-8°C) when Meropenem ACS Dobfar is dissolved in sodium chloride;
• when Meropenem ACS Dobfar is dissolved in dextrose, the solution must be used immediately.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the medicine should be used immediately.
If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Do not freeze the reconstituted solution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Meropenem ACS Dobfar contains
Each vial contains meropenem trihydrate equivalent to 500 mg of anhydrous meropenem.
Each vial contains meropenem trihydrate equivalent to 1000 mg of anhydrous meropenem.
The excipient is anhydrous sodium carbonate.

Description of the appearance of Meropenem ACS Dobfar and contents of the pack
Meropenem ACS Dobfar is a white to pale yellow powder in a vial stoppered with a grey bromobutyl rubber closure, sealed with an aluminium seal coloured purple for the 500 mg strength and grey for the 1 g strength.
Pack: 10 vials

Marketing Authorization Holder
ACS Dobfar S.p.A.
Viale Addetta 4/12,
20067, Tribiano (MI)
Italy

Responsible manufacturer for batch release
ACS Dobfar S.p.A
Nucleo Industriale S. Atto,
S. Nicolò a Tordino, 64100 Teramo, Italy

This patient information leaflet was last approved in 07/2025.

The following information is intended exclusively for physicians or healthcare professionals:
Instructions for self-administration or administration to others of Meropenem ACS Dobfar at home
Some patients, parents or caregivers have been trained to administer Meropenem ACS Dobfar at home.

Warning – This medicinal product may be self-administered or administered to others at home only after receiving appropriate training from a physician or nurse.

How to prepare this medicine

• 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.
  1. Wash and thoroughly dry your hands. Prepare a clean work area.
  2. Remove the Meropenem ACS Dobfar container (the vial) from its package. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
  3. Remove the coloured cap and clean the grey rubber stopper with alcohol. Allow the rubber stopper to dry.
  4. Insert a new sterile needle into a new sterile syringe, without touching the tips.
  5. Draw up the recommended amount of sterile “Water for Injections” into a syringe. The required volume of liquid is indicated in the table below:

Note: If the prescribed dose of Meropenem ACS Dobfar is higher than 1 g, you will need to use more than one vial of Meropenem ACS Dobfar. You may then withdraw the liquid from the vials using a syringe.

6. Insert the needle of the syringe into the centre of the grey rubber stopper of the vial and inject the recommended amount of water for injections into the Meropenem ACS Dobfar vial or vials.
7. 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 rubber to dry.
8. With the plunger fully inserted inside the barrel of the syringe, reattach the needle to the top of the grey rubber stopper. Hold both the syringe and the vial in your hands and turn the vial upside down.
9. Keeping the tip of the needle immersed in the liquid, pull back the plunger of the syringe to withdraw all the liquid from the vial into the syringe.
10. Remove the needle and syringe from the vial and dispose of the empty vial safely.
11. Hold the syringe upright with the needle tip pointing upwards. Tap the syringe gently so that any air bubbles rise to the surface.
12. Remove any air present in the syringe by gently pushing the plunger until all air is expelled.
13. If you are using Meropenem ACS Dobfar at home, dispose of used needles and infusion lines appropriately. If your doctor decides to discontinue treatment, dispose of any unused Meropenem ACS Dobfar appropriately.

How to administer the injection
This medicine can also be administered through a small cannula or Venflon®, or via a port-type catheter or central infusion line.
Administration of Meropenem ACS Dobfar through a small cannula or Venflon®

1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
2. 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.
3. Slowly push the plunger of the syringe to administer the antibiotic steadily over approximately 5 minutes.
4. Once the antibiotic administration is complete and the syringe is empty, remove the syringe and flush the site as recommended by your doctor or nurse.
5. Close the cannula cap and carefully dispose of the syringe in a sharps container.

Administration of Meropenem ACS Dobfar via a port-type catheter or central
infusion line

1. Remove the cap from the port or line, clean the end of the line with alcohol and allow it to dry.
2. Attach the syringe and gently push the plunger to administer the antibiotic steadily over approximately 5 minutes.
3. After completing the antibiotic administration, remove the syringe and flush the site as recommended by your doctor or nurse.
4. Attach a new sterile cap to the central infusion line and carefully dispose of the syringe in a sharps container.