ARCHIFAR 500 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

2. What you need to know before you use Archifar

Do not use Archifar:

• if you are allergic to meropenem or 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.

Warnings and precautions

Talk to your doctor or nurse before starting Archifar if:

• you have health problems, such as liver or kidney problems.
• you have had severe diarrhea after taking other antibiotics.

You may develop a positive reaction to a test (Coombs test) that indicates 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 doubts, consult your doctor or nurse before using Archifar.

Using Archifar with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This is because Archifar can affect how some medicines work, and some of these may have an effect on Archifar.

In particular, tell 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 decrease 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 may be pregnant, or plan 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 during breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Archifar has been associated with headache and tingling or numbness in the skin (paresthesia). Either of these side effects could affect your ability to drive or use machines.

Archifar may cause involuntary muscle movements, which can cause the body to shake rapidly and uncontrollably (convulsions). This is usually accompanied by a loss of consciousness. Do not drive or use machines if you experience this side effect.

Archifar contains sodium

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

Archifar 1 g contains approximately 90 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 4.5% of the maximum recommended daily 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 area of the body where it is located, and its severity. Your doctor will decide what dose you need.
• The normal dose in adults is between 500 mg (milligrams) and 2 g (grams). You will usually be given a dose every 8 hours. However, if your kidneys do not work well, you may receive the dose less frequently.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years is decided using the child's age and weight. The normal dose is between 10 mg and 40 mg of Archifar per kilogram (kg) of the child's weight. You will usually be given a dose every 8 hours. Children who weigh over 50 kg will be given an adult dose.

How to use Archifar

• Archifar will be administered to you as an injection or infusion into a large vein.
• Archifar will usually be administered by your doctor or nurse.
• However, some patients, parents, or caregivers are trained to administer Archifar at home. The instructions for this are found in this leaflet (in the section called "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 doubts.
• Your injection should not be mixed with or added to solutions that contain other medicines.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor will tell you how Archifar is administered.
• Injections should usually be administered at the same time every 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 forget an injection, you should receive it as soon as possible. However, if it is almost time for your next injection, do not receive the missed one.

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

If you stop treatment with Archifar

Do not stop using Archifar until your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions

If you experience a severe allergic reaction, stop treatment with Archifar and go to a doctor immediately. You may need urgent medical treatment. Symptoms can include:

• 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.

Damaged red blood cells(unknown frequency)

Symptoms include:

• Shortness of breath when you do not expect it.
• Red or brown urine.

If you notice any of the above, go to a doctor immediately.

Other possible side effects:

Common(may affect up to 1 in 10 people)

• Abdominal pain (stomach pain).
• Nausea.
• Vomiting.
• Diarrhea.
• Headache.
• Skin rash, itching.
• Pain and inflammation.
• Increased platelet count in the blood (found in a blood test).
• Changes in blood tests, including tests that show how your liver is working.

Uncommon(may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in platelet count (which can make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in the amount of a substance called "bilirubin". Your doctor may perform blood tests periodically.
• Changes in blood tests, including tests that show how your kidneys are working.
• Tingling sensation (numbness).
• Mouth or vaginal infections caused by a fungus (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 perform blood tests periodically.
• Sudden onset of a severe skin rash or blistering or peeling of the skin. This may be associated with high fever and joint pain.

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 with fever, skin rash, and changes in blood tests that control liver function (increased liver enzyme values) and increased white blood cell count (eosinophilia) and enlarged lymph nodes. These may be symptoms of a multi-organ sensitivity disorder known as DRESS syndrome.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//www.notificaram.es. By reporting side 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 which is stated on the label after EXP. The expiry date is the last day of the month stated.

Injection

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

• 3 hours when stored at a temperature up to 25°C;
• 12 hours when stored in a refrigerator (2-8°C).

Infusion

After reconstitution: The reconstituted solutions for infusion should be used immediately. The time between the start of reconstitution and the end of the infusion should 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 in a refrigerator (2-8°C) when the medicine is dissolved in sodium chloride;
• when the medicine is dissolved in dextrose, the solution should be used immediately.

From a microbiological point of view, unless the method of opening/reconstitution/dilution eliminates the risk of microbiological contamination, the product should be used immediately.

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

Do not freeze the reconstituted solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Archifar

• The active ingredient 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 Container Contents

White to light yellow crystalline powder.

20 ml and 30 ml Type I transparent glass vial.

This medication is supplied in packages of 1, 10, 25, 50, and 100 vials.

Only some package 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

You can request more information about this medication by contacting 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

Health Advice/Education

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

Sometimes, a bacterial infection does not respond to treatment with an antibiotic. 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 with caution can help reduce the opportunity for bacteria to become resistant to them.

When your doctor prescribes antibiotic treatment, it is to treat only your current illness. Paying attention to the following tips will help prevent the emergence of resistant bacteria that could stop the antibiotic from working.

2. You should not use an antibiotic unless it has been specifically prescribed for you, and you should only use it to treat the infection for which it was prescribed.
3. You should not use antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
4. You should not give antibiotics prescribed for you to other people.
5. If you have any leftover antibiotic after completing treatment as directed by your doctor, you should take it to the pharmacy for proper disposal.

Date of the last revision of this package insert: October 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

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 medication to yourself or another person at home after a doctor or nurse has trained you.

Injection

To use meropenem for intravenous bolus injection, it should be reconstituted with sterile water for injection to a final concentration of 50 mg/ml.

Infusion

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

How to prepare this medication

• The medication must be mixed with another liquid (the diluent). Your doctor will tell you what amount of diluent to use.
• Use the medication immediately after preparation. Do not freeze it.

2. Remove the Archifar vial from the package. Check the vial and expiration date. Check that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the gray rubber stopper with a cotton swab soaked in alcohol. Let the rubber stopper dry.
4. Insert a new sterile needle into a new sterile syringe, without touching the ends.
5. Draw up the recommended amount of sterile "Water for Injection" with the syringe. The amount of liquid you need is shown in the table below:

Note that:If the amount of Archifar prescribed for you is more than 1 g, you will need to use more than one Archifar vial. You can then draw up the liquid from the vials into a syringe.

1. Pierce the center of the gray 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 it well for about 5 seconds, or until all the powder has dissolved. Clean the gray rubber stopper again with a new cotton swab soaked in alcohol and let it dry.
3. With the syringe plunger fully pushed into the syringe, pierce the gray rubber stopper again with the needle. You should then hold the syringe and vial and turn the vial upside down.
4. Keeping the needle tip in the liquid, pull the plunger and draw up all the liquid from the vial into the syringe.
5. Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.
6. Hold the syringe vertically, with the needle facing up. Gently tap the syringe to make any bubbles in the liquid rise to the top of the syringe.
7. Remove the air from the syringe by gently pushing the plunger until the air has been expelled.
8. If you are using Archifar at home, properly dispose of the needles and infusion lines you have used. If your doctor decides to interrupt your treatment, properly dispose of any unused Archifar.

Administration of the Injection

You can administer this medication through a peripheral intravenous catheter or through a central port or line.

Administration of Archifar through a Peripheral Intravenous Catheter

1. Remove the needle from the syringe and carefully discard it in your sharp objects container.
2. Clean the end of the catheter with a cotton swab soaked in alcohol and let it dry. Open the catheter cap and connect the syringe.
3. Slowly press the syringe plunger to administer the antibiotic constantly over about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and flush the line as your doctor or nurse has recommended.
5. Close the catheter cap and carefully discard the syringe in your sharp objects container.

Administration of Archifar through a Central Port or Line

1. Remove the cap from the port or line, clean the end of the line with a cotton swab soaked in alcohol, and let it dry.
2. Connect the syringe and slowly press the plunger to administer the antibiotic constantly over about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and flush the line as your doctor or nurse has recommended.
4. Place a new clean cap on the central line and carefully discard the syringe in your sharp objects container.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.