Meropenem Kalceks

Package leaflet: Information for the user

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

meropenem
equivalent medicine
Please read all of this leaflet carefully before using 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 or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What Meropenem Kalceks is and what it is used for
2. What you need to know before using Meropenem Kalceks
3. How to use Meropenem Kalceks
4. Possible side effects
5. How to store Meropenem Kalceks
6. Contents of the pack and other information

1. What Meropenem Kalceks is and what it is used for

Meropenem Kalceks 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.
This medicine is used to treat the following conditions in adults and children aged 3 months and older:

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

This medicine may be used to treat febrile neutropenic patients when a bacterial infection is suspected.
This medicine may also be used to treat bacterial blood infections (bacteraemia) that could be associated with one of the above-mentioned infections.

2. What you need to know before using Meropenem Kalceks

Do not use Meropenem Kalceks 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 or nurse before using this medicine if:

• you have health problems, such as liver or kidney disease;
• you have previously 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.
Liver problems
Inform your doctor if you notice yellowing of the skin or eyes, skin itching, dark-coloured urine,
or pale-coloured stools. These could be signs of a liver problem, which your doctor will need to
investigate.
If you are unsure whether any of the above applies to you, consult your doctor or nurse before using
this medicine.
Other medicines and Meropenem Kalceks
Inform your doctor if you are taking, have recently taken, or might take any other
medicines.
This is because Meropenem Kalceks may affect the way some medicines work, and conversely, some medicines may affect Meropenem Kalceks.
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). Meropenem should not be used because it could reduce the effect of sodium valproate;
• oral anticoagulant (used to treat or prevent blood clots).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine.
Pregnancy
It is preferable to avoid taking meropenem during pregnancy. Your doctor will decide whether you should
use this medicine.
Breastfeeding
It is important that you inform your doctor if you are breastfeeding or intend to breastfeed before taking
meropenem. Small amounts of the drug may pass into breast milk. Therefore, your doctor
will decide whether you should use meropenem during breastfeeding.
Driving and using machines
No studies have been conducted on the effect on the ability to drive vehicles or use machinery.
Meropenem has been associated with headache, tingling, or a sensation of tingling of the skin
(paresthesia). Any of these side effects may affect your ability to drive vehicles or
use machinery. This medicine 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 this side effect occurs.
Meropenem Kalceks contains sodium
Meropenem Kalceks 500 mg: this medicine contains 45 mg of sodium (the main component of
table salt) per vial. This corresponds to 2.25% of the maximum daily dietary intake
recommended for an adult.
Meropenem Kalceks 1 g: this medicine contains 90 mg of sodium (the main component of
table salt) per vial. This corresponds to 4.5% of the maximum daily dietary intake
recommended for an adult.

3. How to use Meropenem Kalceks

Use this medicine exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor or nurse.
Use in adults

• The dose depends on the type of infection you have, its location in the body, and 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). Usually, a dose is given every 8 hours. However, you may receive the dose less frequently if your kidneys are not functioning properly (depending on the severity of renal impairment, you may be given a dose every 12 hours or every 24 hours).

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 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 same dosage as adults.

How to use Meropenem Kalceks

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

If you use more Meropenem Kalceks than you should
If you accidentally receive more medicine than prescribed, inform your doctor immediately or go to the
nearest hospital emergency department.
If you forget to use Meropenem Kalceks
If you miss an injection, administer it as soon as possible. However, if it is almost time for the next
injection, 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 Kalceks
Do not stop treatment with this medicine until your doctor tells you it is safe to do so. If you have any doubts about using this medicine, consult your doctor or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Severe allergic reactions (uncommon)
If you experience any of the following signs or symptoms, seek immediate medical advice. You may
need urgent medical treatment. Signs and symptoms may 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 including:

• Severe hypersensitivity reactions including fever, rash, changes in blood tests indicating liver function (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 (frequency not known).
• A skin condition (called "generalised exanthematous pustulosis") accompanied by fever, consisting of numerous small fluid-filled blisters within large areas of swollen and reddened skin (frequency not known).
• Severe red, scaly skin rash, pus-filled lumps, blisters or skin peeling, which may be associated with high fever and joint pain (uncommon).
• Severe skin reactions that may appear as red, circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, 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). Signs include:

• Shortness of breath at unexpected times.
• Red or brown colouration of urine.

If you notice any of the above signs, consult a doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

• Tingling sensation (pins and needles).

• Mouth or vaginal fungal infections (candidiasis).

• Inflammation of the intestine with diarrhoea.

• Pain in the veins when this medicine is injected.

• Blood changes, including a decrease in the number of platelets (which may cause easier bruising), an increase in certain white blood cells, a decrease in other white blood cells, and an increase in a substance called 'bilirubin'. Your doctor will periodically perform blood tests.

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

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

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

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

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

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at https://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 Kalceks

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Injection
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 one hour.
Infusion
The reconstituted solution must be diluted immediately after reconstitution. The time interval between
the start of reconstitution and the end of intravenous infusion must not exceed one hour.
Do not freeze the reconstituted solution.
Do not use this medicine after the expiry date stated on the carton after “Scad.” and on the label after
“EXP”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Meropenem Kalceks contains

• The active substance 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.

Description of the appearance of Meropenem Kalceks and contents of the pack
Meropenem is a powder ranging from white to pale yellow. The vials are packaged in a cardboard box.
Pack sizes: 1 or 10 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 71E, Rīga, 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

This medicinal product is authorised in the European Economic Area countries with the following names:
Denmark Meropenem Kalceks
Austria, Germany Meropenem Kalceks 500 mg Powder for solution for injection/infusion
Meropenem Kalceks 1 g Powder for solution for injection/infusion
Italy, Norway, Sweden Meropenem Kalceks
Belgium Meropenem Kalceks 500 mg, 1 g powder for solution for injection/infusion
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/infūziju šķīduma 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 soluţie injectabilă/perfuzabilă
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

Warning/Medical advice
Antibiotics are used to treat infections caused by bacteria. They are not effective against infections caused by viruses.
Sometimes, bacterial infections do not respond to a course of antibiotic therapy. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics correctly can help reduce the likelihood of bacteria becoming resistant to them.
When a doctor prescribes an antibiotic treatment, it is intended solely for the current illness. Following the advice below will help prevent the development of bacterial resistance, which can stop antibiotics from working.

• It is very important to take the correct dose of antibiotic, at the right times, and for the correct number of days. Read the instructions on the leaflet carefully and ask your doctor or pharmacist for clarification if anything is unclear.
• You must not take antibiotics unless they have been specifically prescribed for you, and you should use them only to treat the infection for which they were prescribed.
• You must not take antibiotics that were prescribed for someone else, even if they have an infection similar to yours.
• You must not give antibiotics prescribed for you to other people.
• If you have leftover antibiotics after completing the course prescribed by your doctor, you must return them to a pharmacy for proper disposal.

Instructions for self-administration or administration to others of Meropenem Kalceks at home
Some patients, parents, or caregivers have been trained to administer Meropenem Kalceks at home.
Caution – This medicine may be self-administered or administered to others at home only after receiving appropriate training from a doctor or nurse.

Injection
Meropenem for intravenous bolus injection must be reconstituted with sterile “Water for Injections” to a final concentration of 50 mg/ml.
The reconstitution time should not exceed 2 minutes.

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

How to prepare this medicine

• Each vial is for single use only.
• The medicine must not be mixed with other liquids (diluents) except those mentioned above. Your doctor will indicate the amount of diluent to use.
• Use the medicine immediately after preparation. Do not freeze it.
• Wash your hands thoroughly and dry them well. Prepare a clean workspace.
• Remove the Meropenem Kalceks vial from its packaging. Check the vial and its expiry date. Ensure the vial is intact and undamaged.
• Remove the coloured cap and clean the grey rubber stopper with an alcohol swab. Allow the stopper to dry.
• Insert a new sterile needle into a new sterile syringe, taking care not to touch the ends.
• Draw up the recommended amount of sterile “Water for Injections” and transfer it into the syringe. The required volume of liquid (diluent) is indicated in the table below:

Note: If the prescribed dose of this medicinal product is greater than 1 g, you will need to use more than one vial of Meropenem Kalceks. You may therefore withdraw the diluent liquid and transfer it into a syringe.

• Insert the needle of the syringe through the centre of the rubber stopper of the vial and inject the recommended amount of “Water for Injections” into the vial or vials of Meropenem Kalceks.
• Remove the needle from the vial and shake the vial well until all the powder has dissolved (this usually takes no more than 2 minutes). Clean the rubber stopper again with alcohol and allow it to dry.
• With the plunger of the syringe fully depressed, reinsert the needle through the top of the rubber stopper. Hold both the syringe and the vial and invert the vial.
• Keeping the tip of the needle in the liquid, pull back the plunger and withdraw all the liquid from the vial into the syringe.
• Remove the needle and syringe from the vial and dispose of the empty vial in a safe place.
• Hold the syringe in an upright position with the needle pointing upwards. Tap the syringe gently so that any air bubbles rise to the top of the syringe.
• Remove air from the syringe by gently pushing the plunger until all air has been expelled.
• If you are using this medicine at home, dispose of used needles and infusion lines appropriately. If your doctor decides to discontinue treatment, dispose of any unused Meropenem Kalceks appropriately.
• Visually inspect the prepared solution before administration. Use only a clear, colourless to yellow solution free from particles.

How to administer the injection
This medicinal product can also be administered via a small cannula or venflon, or through a port-type catheter or central infusion line.
Administration of Meropenem Kalceks via a small cannula or venflon

• Remove the needle from the syringe and carefully dispose of the needle into a sharps container.
• Wipe the tip of the small cannula or venflon with alcohol and allow it to dry. Open the cannula cap and connect it to the syringe.
• Slowly push the syringe plunger to administer the antibiotic steadily over approximately 5 minutes.
• Once the antibiotic has been administered and the syringe is empty, remove the syringe and flush the site as recommended by your doctor or nurse.
• Replace the cap on the cannula and carefully dispose of the syringe into a sharps container.

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

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

Any unused medicinal product and waste materials derived from its use should be disposed of in accordance with local regulations.