Meropenem polpharma

Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Meropenem Polpharma (Meropenem 1 g), 1000 mg, powder for solution for injection / infusion
Meropenemum
Meropenem Polpharma and Meropenem 1 g are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

Meropenem Polpharma contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that may cause serious infections.
Meropenem Polpharma is used to treat the following infections in adults and children aged 3 months and older:

• lung infection (pneumonia),
• bronchitis and pneumonia in cystic fibrosis,
• complicated urinary tract infections,
• complicated intra-abdominal infections,
• puerperal and postpartum infections,
• complicated skin and soft tissue infections,
• acute bacterial meningitis.

Meropenem Polpharma may be used to treat febrile neutropenic patients in whom bacterial infection is suspected.
Meropenem Polpharma may be used to treat bacterial blood infections that may be associated with the infections listed above.

2. Important information before using Meropenem Polpharma

When not to use Meropenem Polpharma

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

Warnings and precautions
Before using Meropenem Polpharma, inform your doctor, pharmacist or
nurse:

• if the patient has any health problems such as liver or kidney disease;
• if the patient has previously experienced severe diarrhoea after taking other antibiotics.

During treatment, the patient may have a positive result in a certain test (the so-called Coombs test) indicating the presence of antibodies which may destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience signs and symptoms of severe skin reactions (see section 4). If such symptoms occur, the patient should contact a doctor or nurse immediately so that treatment for these symptoms can be started.
If the patient is unsure whether any of the above situations apply, the patient should inform the doctor before taking Meropenem Polpharma.
Children
Meropenem Polpharma is not recommended for use in children under 3 months of age, because the safety and efficacy of meropenem have not been established in children under 3 months of age.
Meropenem Polpharma and other medicines
Tell your doctor, pharmacist or nurse about any medicines the patient is currently taking, has recently taken or might take in the future. Meropenem Polpharma may affect the action of certain medicines, and other medicines may affect the action of Meropenem Polpharma.
In particular, tell your doctor or nurse if the patient is taking:

• probenecid (used in the treatment of gout),
• valproic acid, sodium valproate or valpromide (used in the treatment of epilepsy). Meropenem Polpharma should not be used, as it may reduce the effectiveness of sodium valproate,
• oral anticoagulants (used to treat or prevent blood clots in blood vessels).

Pregnancy, breast-feeding and fertility
If the patient is pregnant or breast-feeding, suspects she may be pregnant or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
It is recommended to avoid administering meropenem during pregnancy.
The decision whether the patient should receive meropenem will be made by the doctor.
If the patient is breast-feeding or planning to breast-feed, it is very important to inform the doctor before using meropenem. Small amounts of this medicine pass into breast milk; therefore, the decision to use meropenem during breast-feeding will be made by the doctor.
Driving and using machines
Studies on the effect on the ability to drive or operate machinery have not been conducted.
Use of meropenem has been associated with headache and sensations of pricking and numbness (paraesthesia). Each of these adverse effects may affect the ability to drive or operate machinery. Meropenem may also cause involuntary muscle movements leading to rapid and uncontrolled shaking of the whole body (seizures). This is usually accompanied by loss of consciousness. If the patient experiences this adverse effect, he/she should not drive or operate machinery.
Meropenem Polpharma contains sodium
This medicine contains 90 mg of sodium (the main component of table salt) in each vial. This corresponds to 4.5% of the recommended maximum daily sodium intake in the diet of adults.
If the patient's health condition requires monitoring of sodium intake, inform the doctor, pharmacist or nurse.

3. How to use Meropenem Polpharma

This medicine should always be used exactly as instructed by your doctor or nurse. If you are unsure,
discuss this with your doctor or nurse.
Use in adults

• The dose of this medicine depends on the type of infection the patient has, the location of the infection in the body, and the severity of the infection. The doctor will decide the appropriate dose for the patient.
• The usual dose in adults ranges from 500 mg (milligrams) to 2 g (grams). The medicine is usually administered every 8 hours. However, if kidney function is impaired, doses may be given less frequently.

Use in children and adolescents

• The dose of the medicine for children over 3 months of age up to 12 years depends on the child's age and body weight. The usual dose is between 10 mg and 40 mg of Meropenem Polpharma per kilogram (kg) of body weight. The medicine is usually given every 8 hours. Children with body weight above 50 kg should receive the adult dose.

How to use Meropenem Polpharma

• Meropenem Polpharma will be administered to the patient as an injection or infusion into a large vein.
• Meropenem Polpharma will be given by a doctor or nurse.
• However, in some cases, certain patients, parents, or caregivers may be trained to administer Meropenem Polpharma at home. Instructions for self-administration are provided in this leaflet (under "Instructions for self-administration of Meropenem Polpharma at home"). Always use Meropenem Polpharma strictly according to your doctor's instructions. If you have any doubts, consult your doctor.
• The injection solution must not be mixed or added to solutions containing other medicines.
• Administration may last 5 minutes or between 15 and 30 minutes. Your doctor will decide how long the infusion should last for you.
• The medicine should usually be given at the same times each day.

Use of more than the recommended dose of Meropenem Polpharma
If you accidentally receive more medicine than recommended by your doctor, contact your doctor immediately
or go to the nearest hospital.
Missed dose of Meropenem Polpharma
If you miss a dose, administer it as soon as possible. However, if it is almost time for the next dose,
skip the missed dose.
Do not administer a double dose to make up for a missed dose.
Stopping treatment with Meropenem Polpharma
Do not stop using Meropenem Polpharma unless instructed by your doctor.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Severe allergic reactions
If any of the following subjective or objective symptoms occur, seek immediate medical advice
from a doctor or nurse. The patient may urgently require medical assistance.
Objective and subjective symptoms may include rapidly developing:

• 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 reactions including:
• severe hypersensitivity reactions such as fever, skin rash, changes in blood test results used to assess liver function (increased liver enzyme activity), and increased number of a certain type of white blood cells (eosinophils), as well as enlarged lymph nodes. These may be symptoms of a multi-organ hypersensitivity disorder known as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome);
• severe, red, peeling rash, skin lesions containing pus, blisters or skin peeling, which may be associated with fever and joint pain;
• severe skin rashes, which may appear as red, round spots on the trunk, often with blisters in the center, skin peeling, oral, throat, nasal, genital or ocular ulcers, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or in a more severe form (toxic epidermal necrolysis).

Sudden chest pain, which may be a symptom of a potentially severe allergic reaction
called Kounis syndrome, has been observed during the use of other medicines of the same type.
In such a case, contact a doctor or nurse immediately.
Damage to red blood cells (haemolytic anaemia) (uncommon: may occur
in no more than 1 in 100 people)
Symptoms include:

• sudden onset of breathlessness;
• red or brown discoloration of urine.

If any of the above symptoms occur, contact a doctor immediately.
Other possible adverse reactions
Common (may occur in no more than 1 in 10 people)

• abdominal pain;
• nausea;
• vomiting;
• diarrhoea;
• headache;
• rash, itching of the skin;
• inflammation and pain;
• increased number of platelets (in blood tests);
• changes in diagnostic test results indicating liver function.

Uncommon (may occur in no more than 1 in 100 people)

• blood changes, including decreased number of platelets (may cause easy bruising), increased number of certain white blood cells, decreased number of other white blood cells, increased blood bilirubin levels. The doctor may recommend regular blood tests;
• changes in blood test results, including tests indicating kidney function;
• tingling sensation;
• fungal infections of the mouth or vagina (thrush);
• inflammation of the intestine with diarrhoea;
• pain in the veins at the site of administration;
• other blood changes. Symptoms include frequent infections, fever and sore throat. From time to time, the doctor may recommend regular blood tests;
• sudden onset of severe rash or blistering or skin peeling. May occur with fever and joint pain.

Rare (may occur in no more than 1 in 1000 people)

• seizures;
• acute disorientation and confusion (delirium).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49-21-301
Faks: + 48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Meropenem Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Do not store above 30°C.

Injection
After reconstitution: the intravenous injection solution should be administered immediately after preparation.
The prepared solution should not be stored for longer than:

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

Infusion
After reconstitution: the intravenous infusion solution should be administered immediately after preparation.
The prepared solution should not be stored for longer than:

• 6 hours at temperatures up to 25°C, if meropenem has been dissolved in sodium chloride 9 mg/ml (0.9%) infusion solution;
• 24 hours under refrigerated conditions (2–8°C), if meropenem has been dissolved in sodium chloride 9 mg/ml (0.9%) infusion solution;
• if meropenem has been dissolved in glucose 50 mg/ml (5%) infusion solution, the prepared solution should be administered immediately.

From a microbiological standpoint, the solution should be used immediately, unless the method of opening, reconstitution, and dilution excludes the risk of microbiological contamination.
If the solution is not used immediately, the responsibility for storage duration and conditions lies with the user.
Do not freeze the reconstituted solution.
Do not use this medicine if particulate matter is observed or if there is a change in colour. Only use a colourless to yellow solution that is free from visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Meropenem Polpharma contains

• The active substance is meropenem. Each vial contains meropenem trihydrate equivalent to 1000 mg (1 g) of meropenem.
• The other ingredient is: sodium carbonate.

What Meropenem Polpharma looks like and contents of the pack
Meropenem Polpharma is a white to pale yellow powder for solution for injection/infusion, in glass vials.
After reconstitution, the solution is a clear, colourless to yellow liquid.
The 20 ml vial is made of colourless glass, with a butyl rubber stopper, aluminium crimp cap and flip-off cap, packed in a cardboard carton.
The pack contains 10 vials.
For further information, contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Ireland, country of export
Venus Pharma GmbH
Am Bahnhof 1-3
59368 Werne
Germany

Manufacturer
European Pharma Hub Kft.
Gorcsev Ivan Utca 5, 2360 Gyal
Hungary
Venus Pharma GmbH
Am Bahnhof 1-3
59368 Werne
Germany

Parallel Importer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Repackaged in
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56, 02-234 Warszawa
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49, 51-162 Wrocław

Marketing Authorisation Number in Ireland, country of export: PA1610/001/002
Parallel Import Licence Number: 6/26
[parallel importer's logo]

Advice / medical information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
There are cases of bacterial infections that do not respond to antibiotic treatment. One of the most common reasons for such cases is bacterial resistance to the antibiotic used. This means that despite the use of an antibiotic, some bacteria may survive or multiply.
There are many causes of bacterial resistance. Proper use of antibiotics can reduce the likelihood of bacteria developing resistance, which renders antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the correct times, and for the correct number of days. Please read the instructions in the patient leaflet, and if in doubt, consult your doctor or pharmacist for clarification.
2. Do not use an antibiotic unless it has been prescribed for you by a doctor, and use it only to treat the infection for which it was prescribed.
3. Do not use an antibiotic prescribed for someone else, even if their symptoms are similar.
4. Do not give away or share your prescribed antibiotic with other people.
5. Any unused antibiotic prescribed for you should be returned to a pharmacy for proper disposal.

The following information is intended solely for medical or healthcare personnel

Instructions for self-administration of Meropenem Polpharma at home
Some patients, parents, and caregivers may be trained to administer the medicine Meropenem Polpharma at home.
Warning: Self-administration of the medicine at home is permitted only after proper training by a physician or nurse.

How to prepare the medicine

• This medicine must be mixed with another liquid (diluent). Your doctor will instruct you how much diluent to use.
• The medicine should be administered immediately after preparation. Do not freeze the prepared solution.

1. Wash and thoroughly dry your hands. Prepare a clean working area.
2. Remove the vial of Meropenem Polpharma from its packaging. Check the vial and the expiration date. Ensure there are no signs of damage to the medicine’s packaging.
3. Remove the colored cap and wipe the grey rubber stopper with an alcohol-impregnated swab. Wait for the stopper to dry completely.
4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the tips.
5. Draw 20 mL of Water for Injections into the syringe.
6. Pierce the center of the grey rubber stopper with the needle and inject the Water for Injections from the syringe into the vial or vials containing Meropenem Polpharma.
7. Remove the needle from the vial and shake the vial vigorously for about 5 seconds, or until the powder is completely dissolved. Wipe the rubber stopper again with a new alcohol-impregnated swab and wait for it to dry completely.
8. Ensure the plunger of the syringe is fully depressed. Reinsert the needle through the rubber stopper. Hold both the syringe and the vial, then invert the vial.
9. Keeping the needle tip submerged in the solution, pull back the plunger to draw the solution from the vial into the syringe.
10. Remove the syringe with the needle from the vial and place the empty vial in a safe location.
11. Hold the syringe vertically with the needle pointing upward. Gently tap the syringe to allow air bubbles to rise to the top.
12. Carefully expel all air from the syringe by gently pressing the plunger until all gas has been released.
13. If Meropenem Polpharma is being used at home, used needles and infusion lines must be disposed of properly. If the physician decides to discontinue treatment, any unused medicine must be disposed of in accordance with local regulations.

Administration of the medicine
Meropenem Polpharma can be administered via a short cannula or venflon, or through a port or central line.

Administration of Meropenem Polpharma via short cannula or venflon

1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
2. Clean the end of the cannula or venflon with an alcohol-impregnated swab and wait for it to dry. Remove the cannula cap and attach the syringe.
3. Slowly depress the plunger to administer the antibiotic evenly over approximately 5 minutes.
4. After completing the antibiotic infusion and emptying the syringe, disconnect the syringe and flush the cannula as directed by the physician or nurse.
5. Cap the cannula and carefully dispose of the syringe in a sharps container.

Administration of Meropenem Polpharma via port or central line

1. Remove the cap from the port or central line, clean the end of the line with an alcohol-impregnated swab, and wait for it to dry.
2. Attach the syringe and slowly depress the plunger to administer the antibiotic evenly over approximately 5 minutes.
3. After completing the antibiotic infusion, disconnect the syringe and flush the line as directed by the physician or nurse.
4. Attach a new cap to the central line and carefully dispose of the syringe in a sharps container.