Label:Information for the User

Archifar 500 mg Powder for injectable solution and for EFG perfusion

Archifar 1 g Powder for injectable solution and for EFG perfusion

Meropenem

Read this label carefully before starting to use this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult yourdoctor,pharmacistor nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist or nurse,evenif they do not appear in this label. See section 4.

1.What is Archifar and for what it is used

2.What you need to knowbeforestarting touse Archifar

3.How to use Archifar

4.Possible adverse effects

5Storage of Archifar

6.Contents of the package and additional information

Archifar belongs to a group of medications known as carbapenem antibiotics. It acts by destroying bacteria, which can cause severe infections.

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

• Pneumonia, a lung infection
• Respiratory and pulmonary infections in patients with cystic fibrosis
• Complicated urinary tract infections
• Complicated abdominal infections
• Infections that you may acquire during and after childbirth
• Complicated skin and soft tissue infections
• Acute bacterial meningitis, a brain infection

Archifar may be used to treat neutropenic patients (patients with low levels of white blood cells called neutrophils) who present with fever suspected to be due to a bacterial infection.

Archifar can be used to treat bacterial blood infections that may be associated with one of the infections mentioned above.

No use Archifar:

• If you are allergic to meropenem or any of the other components of this medication (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

Consult your doctor or nurse before starting to use 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 response to 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 doubts, consult your doctor or nurse before using Archifar.

Use of Archifarwithother medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is because Archifar may affect the way some medications work, and some of these may have an effect on Archifar.

In particular, inform your doctor or nurse if you are taking any of the following medications:

• Probenecid (used to treat gout).
• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Do not use Archifar, as it may decrease the effect of sodium valproate.
• Oral anticoagulant (used to treat or prevent blood clots).

Pregnancy, breastfeedingand fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.It is preferable to avoid the use of meropenem during pregnancy.

Your doctor will decide if you should use Archifar.

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

Driving and operating machinery

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

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

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 operate machinery if you experience this adverse effect.

Archifar contains sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor.This medicationindicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Use in adults

• The dose depends on the type of infection you present, 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 administered a dose every 8 hours. However, if your kidneys do not function 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 determined 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 administered a dose every 8 hours. Children weighing over 50 kg will be administered an adult dose.

How to use Archifar

• Archifar will be administered to you as an injection or infusion into a large-caliber 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 prospectus (in the section called "Instructions for administering Archifar to yourself or another person at home"). Follow exactly the administration instructions for Archifar indicated by your doctor. Consult your doctor if you have doubts.
• Your injection should not be mixed with or added to solutions containing other medications.
• 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 doses than prescribed, 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 to administer the next injection, do not receive the missed one.

Do not use a double dose (two injections at once) to compensate for the missed doses.

If you interrupt treatment with Archifar

Do not stop Archifar until your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe allergic reactions

If you experience a severe allergic reaction,stop taking Archifar and seek medical attention immediately. You may need urgent medical treatment. Symptoms may include a 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.

Bleeding in red blood cells(unknown)

Symptoms include:

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

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

Other possible side effects:

Frequent(may affect up to 1 in 10 people)

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

Occasional(may affect up to 1 in 100 people)

• Changes in your blood. These include a decrease in platelet count (which may make you bruise more easily), an increase in some white blood cells, a decrease in other white blood cells, and an increase in a substance called “bilirubin”. Your doctor may perform blood tests periodically.
• Changes in blood tests, including tests that show how well your kidneys are working.
• Tickling sensation (tingling).
• Infections of the mouth or vagina 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 severe skin rash or formation of blisters 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).

Unknown frequency(cannot be estimated from available data)

• Severe hypersensitivity reactions with fever, skin rash, and changes in blood tests that control liver function (elevated liver enzyme levels) and increased levels of a type of white blood cell (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 type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label,after CAD. The expiration date is 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 of 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 of up to 25 °C when the medication dissolves in sodium chloride;

- 24 hours when stored under refrigerated conditions (2-8 °C) when the medication dissolves in sodium chloride;

- when the medication dissolves in dextrose, the solution must be used immediately.

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

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

Do not freeze the reconstituted solution.

Medicines must not be disposed of through drains or in the trash. Ask your pharmacisthow to disposeofthecontainers and of themedicines that you no longerneed.By doing so, you will help protect the environment.

Composition of Archifar

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

Aspect of the product and contents of the package

White to light yellow crystalline powder.

Transparent Type I glass vial of 20 ml and 30 ml.

This medicine is supplied in packs of1, 10, 25, 50 and 100 vials.

Only some pack sizes may be marketed.

Holder of the marketing authorizationand manufacturer

Holder of the marketing authorization

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 medicine by contacting the local representative of the holder of the marketing authorization:

Medochemie Iberia S.A., Branch in Spain

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

28044 Madrid

SPAIN

Advice on the use of this medicine

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

Sometimes an infection caused by a bacterium does not respond to treatment with an antibiotic. One of the most common reasons for this to happen is that the bacteria that cause 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 with caution can help reduce the opportunity for bacteria to become resistant to them.

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

1. It is very important that you receive the correct dose of the antibiotic, the right number of times and for the correct number of days. Read the instructions on the leaflet and, if you do not understand something, consult your doctor or pharmacist to explain it to you.
2. You must not use an antibiotic unless it has been specifically prescribed for you, and you must use it only to treat the infection for which it has been prescribed.
3. You must not use antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
4. You must not give antibiotics to other people that have been prescribed for you.
5. If you have any antibiotic left over after receiving the treatment as indicated by your doctor, you must take it to the pharmacy to be disposed of properly.

Last review date of this leaflet: October 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

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

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

Attention – You must only administer this medicine to yourself or to another person at home after a doctor or nurse has trained you.

Injection

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

Perfusion

The vials for intravenous perfusion 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 medicine

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

1. Wash your hands and dry them thoroughly. Prepare a clean working area.
2. Remove the vial (vial) of Archifar from the package. Check the vial and the expiration date. Check that the vial is intact and not damaged.
3. Remove the colored cap and clean the rubber stopper with an alcohol-soaked cotton swab. Let the stopper dry.
4. Insert a new sterile needle into a new sterile syringe, without touching the ends.
5. Draw out the recommended amount of "Sterile Water for Injection" with the syringe. The amount of liquid needed is shown in the table below:

Remember:If the amount of Archifar prescribed is greater than 1 g, you will need to use more than one vial of Archifar. You can then draw out the liquid from the vials in a syringe.

6.Pass the center of the rubber stopper through with the needle of the syringe and inject the recommended amount of Sterile Water for Injection into the vial(s) of Archifar.

7.Remove the needle from the vial and shake it well for about 5 seconds, or until all the powder has dissolved. Clean the rubber stopper again with a new alcohol-soaked cotton swab and let it dry.

8.With the plunger of the syringe pushed all the way in, pass the needle through the rubber stopper again. You should then hold the syringe and the vial and turn the vial upside down.

9.Keeping the end of the needle in the liquid, pull the plunger and draw out all the liquid from the vial into the syringe.

10.Remove the needle and syringe from the vial and dispose of the empty vial in an appropriate container.

11.Hold the syringe vertically, with the needle pointing upwards. Give gentle taps to the syringe to allow any bubbles in the liquid to rise to the top of the syringe.

12.Remove the air from the syringe by pushing the plunger gently until the air has come out.

13.If you are using Archifar at home, dispose of the needles and intravenous lines used properly. If your doctor decides to stop your treatment, dispose of the unused Archifar properly.

Administration of the injection

You can administer this medicine 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 dispose of it properly in a sharps container.
2. Clean the end of the catheter with an alcohol-soaked cotton swab and let it dry. Open the catheter cap and connect the syringe.
3. Push the plunger of the syringe slowly to administer the antibiotic continuously for about 5 minutes.
4. Once you have finished administering the antibiotic and the syringe is empty, remove it and clean the site as recommended by your doctor or nurse.
5. Close the catheter cap and dispose of the syringe properly in a sharps 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 an alcohol-soaked cotton swab and let it dry.
2. Connect the syringe and push the plunger slowly to administer the antibiotic continuously for about 5 minutes.
3. Once you have finished administering the antibiotic, remove the syringe and clean the site as recommended by your doctor or nurse.
4. Replace the cap on the port or line and dispose of the syringe properly in a sharps container.

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