MEROPENEM KALCEKS 500 mg POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Meropenem Kalceks

Do not use Meropenem Kalceks

• if you are allergic (hypersensitive) to meropenem or any of the other components of this medicine (listed in section 6);
• if you are allergic (hypersensitive) 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 to use this medicine if:

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

You may test positive for a test called the Coombs test, which indicates the presence of antibodies that can destroy red blood cells. Your doctor will discuss this with you.

You may experience signs and symptoms of severe skin reactions (see section 4). If this happens, inform your doctor or nurse immediately so that they can treat the symptoms.

If you are unsure if you are in any of these situations, consult your doctor or nurse before using this medicine.

Other medicines and Meropenem Kalceks

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

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

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). Meropenem 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

It is preferable to avoid using meropenem during pregnancy. Your doctor will decide if you should use it.

Breastfeeding

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

Driving and using machines

No studies have been performed on the effects on the ability to drive and use machines. However, meropenem has been associated with headache, tingling, or numbness in the skin (paresthesia). Any of these side effects could affect your ability to drive or use machines. This medicine may cause involuntary muscle movements, which can cause the person's 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.

Meropenem Kalceks contains sodium

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

Meropenem Kalceks 1 g: This medicine contains 90 mg of sodium (main component of table/cooking salt) per vial. This is equivalent to 4.5% of the maximum recommended daily sodium intake for an adult.

3. How to use Meropenem Kalceks

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

Use in adults

• The dose depends on the type of infection you have, the area of the body affected, 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) depending on the type of infection you have. 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 (depending on the severity of the kidney disorder, you will receive a dose every 12 hours or every 24 hours).

Use in children and adolescents

• The dose for children and adolescents 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 meropenem 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 Meropenem Kalceks

• This medicine will be given to you as an injection or infusion into a large vein.
• Normally, this medicine will be given to you by your doctor or nurse.
• However, some patients, parents, or caregivers receive training to administer meropenem at home. The instructions for this are at the end of this leaflet (in the section called "Instructions for administering Meropenem Kalceks to yourself or another person at home").
• The injection must not be mixed with solutions that contain other medicines, nor added to these.
• The injection may take approximately 5 minutes or between 15 and 30 minutes. Your doctor or nurse will tell you how this medicine is administered.
• The injections should normally be given at the same time every day.

If you use more Meropenem Kalceks than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Meropenem Kalceks

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 using Meropenem Kalceks

Do not stop this medicine until your doctor tells you to.

If you have any further questions on 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(uncommon)

If you experience a severe allergic reaction, stop using this medicine and go to a doctor immediately. You may need urgent medical treatment. The signs and symptoms can include a sudden onset of any of the following:

• 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

Severe skin reactionssuch as:

• severe hypersensitivity reactions with fever, rash, and changes in blood test results showing liver activity (increased liver enzyme levels), increased eosinophils, and swollen lymph nodes. These can be signs of a multi-organ sensitivity disorder known as DRESS syndrome (frequency not known).
• a skin disease (known as "acute generalized exanthematous pustulosis"), accompanied by fever and characterized by numerous small blisters filled with fluid that appear on large areas of swollen and reddened skin (frequency not known).
• severe scaly red rash, skin bumps containing pus, blisters, or peeling of the skin that may be associated with high fever and joint pain (uncommon).
• severe skin rashes that can appear as circular red patches, often with central blisters on the trunk, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis) (uncommon).

Damage to red blood cells(uncommon). The signs 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)
• feeling sick (nausea)
• being sick (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 those that show liver activity

Uncommon(may affect up to 1 in 100 people)

• changes in blood tests, including those that show kidney activity
• tingling sensation (paresthesia)
• mouth or vaginal infections caused by a fungus (thrush)
• inflammation of the intestine with diarrhea
• pain in the veins where this medicine is injected
• changes in the blood. These include a decrease in the number of platelets (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.
• other changes in the blood. The symptoms include frequent infections, fever, and sore throat. Your doctor may perform blood tests periodically.

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

• confusion
• seizures (convulsions).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Meropenem Kalceks

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

This medicine does not require special storage conditions.

Injection

The reconstituted solutions for intravenous injection should be used immediately. The time interval between the start of reconstitution and the end of intravenous injection should not exceed one hour.

Infusion

The reconstituted solution should be diluted immediately after reconstitution. The time interval between the start of reconstitution and the end of intravenous infusion should not exceed one hour.

Do not freeze the reconstituted solution.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date is the last day of the month stated.

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

6. Container Contents and Additional Information

Composition of Meropenem Kalceks

The active ingredient is meropenem.

Meropenem Kalceks 500 mg

Each vial contains meropenem trihydrate equivalent to 500 mg of meropenem.

Meropenem Kalceks 1 g

Each vial contains meropenem trihydrate equivalent to 1 g of meropenem.

The other component is sodium carbonate.

Appearance of Meropenem Kalceks and Container Contents

Meropenem is a white to light yellow powder, packaged in glass vials. The vials are placed in cardboard boxes.

Presentation: 1 or 10 (clinical packaging) vials

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AS KALCEKS

Krustpils iela 71E,

Riga, LV-1057,

Latvia

Tel.: +371 67083320

E-mail: [email protected]

Manufacturer

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto (loc. San Nicolò a Tordino)

64100 Teramo (TE), Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Denmark Meropenem Kalceks

Austria, Germany Meropenem Kalceks 500 mg Pulver zur Herstellung einer Injektions-/Infusionslösung

Meropenem Kalceks 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung

Italy, Norway, Sweden Meropenem Kalceks

Belgium Meropenem Kalceks 500 mg, 1 g poeder voor oplossing voor injectie/infusie

Meropenem Kalceks 500 mg, 1 g poudre pour solution injectable/pour perfusion

Meropenem Kalceks 500 mg, 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung

Croatia Meropenem Kalceks 500 mg, 1000 mg prašak za otopinu za injekciju/infuziju

Finland Meropenem Kalceks 500 mg, 1 g injektio-/infuusiokuiva-aine liuosta varten

France MEROPENEM KALCEKS 500 mg poudre pour solution injectable/pour perfusion

MEROPENEM KALCEKS 1 g poudre pour solution injectable/pour perfusion

Hungary Meropenem Kalceks 500 mg, 1 g por oldatos injekcióhoz vagy infúzióhoz

Ireland Meropenem 500 mg, 1 g powder for solution for injection/infusion

Latvia Meropenem Kalceks 500 mg, 1 g pulveris injekciju/infuziju šķiduma pagatavošanai

Lithuania Meropenem Kalceks 500 mg, 1 g milteliai injekciniam ar infuziniam tirpalui

Netherlands Meropenem Kalceks 500 mg, 1 g poeder voor oplossing voor injectie/infusie

Romania Meropenem Kalceks 500 mg, 1 g pulbere pentru solutie injectabila/perfuzabila

Slovenia Meropenem Kalceks 500 mg, 1000 mg prašek za raztopino za injiciranje/infundiranje

Slovakia Meropenem Kalceks 500 mg, 1 g prášok na injekčný/infúzny roztok

Spain Meropenem Kalceks 500 mg, 1 g polvo para solución inyectable y para perfusión EFG

Date of the last revision of this prospectus:December 2022

Detailed 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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Health Advice/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 treatment with an antibiotic. One of the most common reasons for this to happen 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 likelihood of bacteria becoming resistant to them.

When your doctor prescribes you 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.

• You should not take antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
• You should not use antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
• You should not give antibiotics that were prescribed for you to other people.
• If you have leftover antibiotic after receiving treatment as directed by your doctor, you should take it to the pharmacy for proper disposal.

Instructions for Administering Meropenem Kalceks to Yourself or Others at Home

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

Warning: This medication should only be administered to yourself or another person at home after a doctor or nurse has trained you.

Injection

To administer meropenem by intravenous bolus injection, prepare the medication by reconstituting it in 'sterile water for injections' to a final concentration of 50 mg/ml.

The reconstitution time should not exceed 2 minutes.

Infusion

The vials of meropenem for intravenous infusion can be reconstituted directly with 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) glucose solution, and diluted with the same solvent to a final concentration of 1 to 20 mg/ml.

How to Prepare this Medication

• Each vial is for single use.
• This medication should not be mixed with other liquids (solvents) except those mentioned above. Your doctor will tell you how much solvent to use.
• Use the medication immediately after preparation. Do not freeze it.
• Wash your hands and dry them thoroughly. Prepare a clean work area.
• Remove the Meropenem Kalceks vial from the cardboard box. Check the vial and expiration date. Verify that the vial is intact and has not been damaged.
• Remove the colored cap and clean the stopper with an alcohol swab. Let the stopper dry.
• Insert a new sterile needle into a new sterile syringe, without touching the ends.
• Draw up the recommended amount of 'sterile water for injections' with the syringe. The amount of liquid (solvent) you need is shown in the following table:

Notes:If the amount of this medication prescribed for you is more than 1 g, you will need to use more than one Meropenem Kalceks vial. You can then draw up the liquid (solvent) from the vials into a syringe.

• Pierce the center of the rubber stopper with the syringe needle and inject the recommended amount of 'sterile water for injections' into the Meropenem Kalceks vial(s).
• Remove the needle from the vial and shake it well until all the powder has dissolved (this should not take more than 2 minutes). Clean the rubber stopper with alcohol again and let it dry.
• With the syringe plunger fully inserted, pierce the top of the rubber stopper with the needle again. Then, you should hold both the syringe and the vial and turn it upside down.
• Keeping the needle tip in the liquid, pull the plunger and draw all the liquid from the vial into the syringe.
• Remove the needle and syringe from the vial and discard the empty vial in an appropriate container.
• 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.
• Remove the air from the syringe by gently pushing the plunger until the air has been expelled.
• If you are using this medication at home, dispose of the needles and infusion lines you have used properly. If your doctor decides to interrupt your treatment, dispose of the unused Meropenem Kalceks properly.
• Inspect the prepared solution visually before administration. The solution should only be used if it is transparent, colorless, or yellow and particle-free.

Administration of the Injection

You can administer this medication through a short intravenous catheter, an intravenous line, or through a central port or line.

Administration of Meropenem Kalceks through a Short Intravenous Catheter or Intravenous Line

• Remove the needle from the syringe and carefully discard it in authorized containers for sharp objects.
• Clean the end of the intravenous catheter or line with alcohol and let it dry. Open the cap of your catheter and connect the syringe.
• Slowly press the syringe plunger to administer the antibiotic constantly over about 5 minutes.
• 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.
• Close the cap of the catheter and carefully discard the syringe in authorized containers for sharp objects.

Administration of Meropenem Kalceks through a Central Port or Line

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

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