Archifar 1 g powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Archifar 500 mg Powder for solution for injection and infusion EFG

Archifar 1 g Powder for solution for injection and infusion EFG

Meropenem

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Archifar is and what it is used for

2. What you need to know before using Archifar

3. How to use Archifar

4. Possible side effects

5. Storage of Archifar

6. Contents of the pack and other information

1. What Archifar is and what it is used for

Archifar belongs to a group of medicines called carbapenem antibiotics. It works by destroying bacteria that can cause serious infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Archifar is used to treat the following infections in adults and children aged 3 months and older:

• Infection affecting the lungs (pneumonia)
• Bronchial and lung infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections that may occur during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial infection of the brain (meningitis)

Archifar may be used to treat febrile neutropenic patients (patients with low levels of white blood cells called neutrophils) in whom a bacterial infection is suspected.

Archifar may also be used to treat bacterial blood infection (bacteraemia) that could be associated with one of the types of infection listed above.

2. What you need to know before using Archifar

Do not use Archifar:

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

You may develop a positive reaction in a test (Coombs test) indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.

Liver problems

Inform your doctor if you notice yellowing of the skin or eyes, itching, dark-colored urine, or pale stools. These may be signs of liver problems that your doctor needs to investigate.

Warnings and precautions

Talk to your doctor or nurse before starting Archifar if:

• you have any health problems, such as liver or kidney issues.
• you have previously experienced severe diarrhea after taking other antibiotics.

You may develop a positive reaction in a test (Coombs test) indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.

If you are in any of these situations, or if you have any doubts, consult your doctor or nurse before using Archifar.

Using Archifar with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is because Archifar may affect how some medicines work, and some of these medicines may in turn affect Archifar.

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). Archifar should not be used, as it may reduce the effect of sodium valproate.
• Oral anticoagulant agent (used to treat or prevent blood clots).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is preferable to avoid using meropenem during pregnancy.

Your doctor will decide whether you should use Archifar.

It is very important that you inform your doctor if you are breastfeeding or plan to breastfeed before receiving treatment with meropenem. A small amount of this medicine may pass into breast milk. Therefore, your doctor will decide whether you should use Archifar while breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or operate machinery.

Archifar has been associated with headache and tingling or pricking sensations in the skin (paresthesia). Either of these adverse effects could affect your ability to drive or operate machinery.

Archifar may cause involuntary muscle movements, which may lead to rapid and uncontrolled shaking of the body (seizures). This is usually accompanied by loss of consciousness. Do not drive or operate machinery if you experience this adverse effect.

Archifar contains sodium

Archifar 500 mg contains approximately 45 mg of sodium (the main component of cooking/table salt) per vial. This corresponds to 2.25% of the maximum daily recommended dietary intake of sodium for an adult.

Archifar 1 g contains approximately 90 mg of sodium (the main component of cooking/table salt) per vial. This corresponds to 4.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Archifar

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Use in adults

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

Use in children and adolescents

• The dose for children over 3 months of age and up to 12 years is determined based on the child's age and weight. The usual dose ranges between 10 mg and 40 mg of Archifar per kilogram (kg) of body weight. Normally, a dose is administered every 8 hours. Children weighing more than 50 kg will receive an adult dose.

How to use Archifar

• Archifar will be administered as an injection or intravenous infusion into a large vein.
• Usually, Archifar is administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Archifar at home. Instructions for this are provided in this leaflet (in the section titled “Instructions for administering Archifar to yourself or another person at home”). Follow exactly the administration instructions for Archifar as indicated by your doctor. Consult your doctor if you have any doubts.
• Your injection must not be mixed with or added to solutions containing other medicines.
• The injection may last approximately 5 minutes or between 15 and 30 minutes. Your doctor will inform you how Archifar is administered.
• Injections should normally be given at the same time each day.

If you use more Archifar than you should

If you accidentally use more than the prescribed dose, contact your doctor or go to the nearest hospital immediately.

If you forget to use Archifar

If you miss an injection, it should be administered as soon as possible. However, if it is almost time for your next dose, do not take the missed dose.

Do not use a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Archifar

Do not stop Archifar until your doctor tells you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Severe allergic reactions

If you experience a severe allergic reaction, stop treatment with Archifar and seek medical attention immediately. You may require urgent medical treatment. Symptoms may include sudden onset of:

• Severe rash, itching, or hives on the skin.
• Swelling of the face, lips, tongue, or other parts of the body.
• Shortness of breath, wheezing, or difficulty breathing.

Damage to red blood cells (frequency not known)

Symptoms include:

• Shortness of breath when not expected.
• Red or brown urine.

If you notice any of the above, seek medical advice immediately.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Abdominal (stomach) pain.
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increase in the number of platelets in the blood (detected in a blood test).
• Changes in blood tests, including tests showing how your liver is functioning.

Uncommon (may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in the number of platelets (which may make you bruise more easily), increase in certain white blood cells, decrease in other white blood cells, and increase in a substance called “bilirubin”. Your doctor may carry out periodic blood tests.
• Changes in blood tests, including tests showing how your kidneys are functioning.
• Tingling sensation (pins and needles).
• Fungal infections of the mouth or vagina (thrush).
• Inflammation of the intestine with diarrhea.
• Pain in the veins where Archifar is injected.
• Other changes in your blood. Symptoms include frequent infections, fever, and sore throat. Your doctor may carry out periodic blood tests.
• Sudden onset of severe skin rash, blistering, or skin peeling. This may be associated with high fever and joint pain.
• Decrease in blood potassium levels (which may cause weakness, muscle cramps, tingling, and irregular heart rhythm).
• Liver problems. Yellowing of the skin and eyes, itching, dark urine, or pale stools. If you notice these signs or symptoms, consult a doctor immediately.

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

• Seizures (fits).

Frequency not known (cannot be estimated from available data)

• Severe hypersensitivity reactions with fever, skin rashes, and changes in blood tests indicating liver function abnormalities (elevated liver enzyme levels), increase in a type of white blood cells (eosinophilia), and enlarged lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as DRESS syndrome.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Archifar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label, after EXP. The expiry date refers to the last day of the month indicated.

Injection

After reconstitution: Reconstituted solutions for injection must be used immediately. The time interval between the start of reconstitution and the end of injection must not exceed:

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

Infusion

After reconstitution: Reconstituted solutions for infusion must be used immediately. The time interval between the start of reconstitution and the end of infusion must not exceed:

• 3 hours when stored at a temperature up to 25°C when the medicine is dissolved in sodium chloride;
• 24 hours when stored under refrigerated conditions (2–8°C) when the medicine is dissolved in sodium chloride;
• when the medicine 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 product should be used immediately.

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

Do not freeze the reconstituted solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Archifar

• The active substance is meropenem. Each vial contains meropenem trihydrate equivalent to 500 mg and 1 g of anhydrous meropenem, respectively.
• The other component is sodium carbonate.

Appearance of the product and contents of the container

White to pale yellow crystalline powder.

Clear Type I glass vials of 20 ml and 30 ml.

This medicine is supplied in pack sizes of 1, 10, 25, 50 and 100 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Iberia, S.A.

Rua José Maria Nicolau, nº6, 7ºB,

São Domingos de Benfica, 1500 662 Lisboa,

Portugal

Manufacturer

Medochemie Ltd (Factory C)

2 Michael Erakleous Street,

Agios Athanassios Industrial Area,

4101 Agios Athanassios, Limassol

Cyprus

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Advice/health education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes, a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully may help reduce the chance of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic treatment, it is intended only for your current illness. Following the advice below will help prevent the development of resistant bacteria that could stop antibiotics from working.

1. It is very important that you receive the correct dose, at the right times, and for the correct number of days. Read the instructions in this leaflet carefully, and if you do not understand something, consult your doctor or pharmacist for clarification.
2. You should not use an antibiotic unless it has been specifically prescribed for you, and you should use it only to treat the infection for which it was prescribed.
3. You should not use antibiotics prescribed for other people, even if they had an infection similar to yours.
4. You should not give other people antibiotics that were prescribed for you.
5. If you have leftover antibiotics after completing your treatment as directed by your doctor, return them to your pharmacy for proper disposal.

Date of the most recent review of this leaflet: July 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended for healthcare professionals only:

Instructions for administering Archifar to yourself or another person at home:

Some patients, parents, and caregivers are trained to administer Archifar at home.

Warning – You should only administer this medicine to yourself or another person at home after being trained by a doctor or nurse.

Injection

For intravenous bolus injection, meropenem must be reconstituted with sterile water for injection to a final concentration of 50 mg/ml.

Infusion

Meropenem vials for intravenous infusion may be reconstituted directly with infusion solutions of sodium chloride 9 mg/ml (0.9%) or dextrose 50 mg/ml (5%) to a final concentration of 1 to 20 mg/ml.

How to prepare this medicine

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

1. Wash your hands thoroughly and dry them well. Prepare a clean working area.
2. Remove the Archifar vial from its packaging. Check the vial and the expiration date. Ensure the vial is intact and undamaged.
3. Remove the colored cap and clean the grey rubber stopper with an alcohol-impregnated cotton swab. Allow the rubber stopper to dry.
4. Insert a new sterile needle into a new sterile syringe, taking care not to touch the tips.
5. Draw up the recommended amount of sterile “Water for Injection” into the syringe. The amount of liquid required is shown in the table below:

Dosage of Archifar	Amount of “Water for Injection” required for dilution
500 mg (milligrams)	10 ml (milliliters)
1 g (gram)	20 ml
1.5 g	30 ml
2 g	40 ml

Please note: If the amount of Archifar prescribed for you is greater than 1 g, you will need to use more than one Archifar vial. You may then draw the liquid from the vials into a syringe.

1. Pierce the center of the grey rubber stopper with the syringe needle and inject the recommended amount of Water for Injection into the Archifar vial(s).
2. Remove the needle from the vial and shake well for about 5 seconds, or until all the powder has dissolved. Wipe the grey rubber stopper once again with a new alcohol-impregnated cotton swab and allow it to dry.
3. With the syringe plunger fully depressed, pierce the grey rubber stopper again with the needle. Then hold the syringe and vial together and invert the vial.
4. Keeping the needle tip in the liquid, pull back the plunger to withdraw all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and dispose of the empty vial in an appropriate container.
6. Hold the syringe vertically with the needle pointing upward. Gently tap the syringe so that any air bubbles rise to the top.
7. Expel air from the syringe by gently pushing the plunger until the air has been completely removed.
8. If you are using Archifar at home, properly dispose of used needles and infusion sets. If your doctor decides to discontinue your treatment, properly dispose of any unused Archifar.

Administration of the injection

You may administer this medicine through a peripheral intravenous catheter, or through a port or central line.

Administration of Archifar through a peripheral intravenous catheter

1. Remove the needle from the syringe and carefully dispose of it in your sharps container.
2. Clean the end of the catheter with an alcohol-impregnated cotton swab and allow it to dry. Open the catheter cap and attach the syringe.
3. Slowly push the syringe plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
4. Once administration of the antibiotic is complete and the syringe is empty, remove it and flush the line as instructed by your doctor or nurse.
5. Close the catheter cap and carefully dispose of the syringe in your sharps container.

Administration of Archifar through a port or central line

1. Remove the cap from the port or line, clean the end of the line with an alcohol-impregnated cotton swab, and allow it to dry.
2. Attach the syringe and slowly push the plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
3. After completing administration of the antibiotic, remove the syringe and flush the line as instructed by your doctor or nurse.
4. Place a new clean cap on the central line and carefully dispose of the syringe in your sharps container.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.