MEROPENEM 2000 mg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Meropenem AptaPharma, 2000 mg, powder for solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Meropenem AptaPharma and what is it used for
4. Important information before using Meropenem AptaPharma
   1. When not to use Meropenem AptaPharma
   2. Warnings and precautions
   3. Children
   4. Meropenem AptaPharma and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Meropenem AptaPharma contains sodium
5. How to use Meropenem AptaPharma
   1. Use in adults
   2. Use in children and adolescents
   3. How to use Meropenem AptaPharma
   4. Using a higher dose of Meropenem AptaPharma than recommended
   5. Missing a dose of Meropenem AptaPharma
   6. Stopping the use of Meropenem AptaPharma
6. Possible side effects
   1. Severe allergic reactions
   2. Other possible side effects:
   3. Common (may occur in less than 1 in 10 people)
   4. Uncommon (may occur in less than 1 in 100 people)
   5. Rare (may occur in less than 1 in 1000 people)
   6. Reporting side effects
7. How to store Meropenem AptaPharma
   1. Infusion
8. Contents of the packaging and other information
   1. What Meropenem AptaPharma contains
   2. What Meropenem AptaPharma looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized for use in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:
   7. Advice/medical education
   8. The following information is intended for medical personnel or healthcare professionals only
   9. Preparation of infusion

Leaflet accompanying the packaging: patient information

Meropenem AptaPharma, 2000 mg, powder for solution for infusion

Meropenem

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Meropenem AptaPharma contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. Its action is to kill bacteria that can cause severe infections.
Meropenem AptaPharma is used to treat the following infections in adults and children over 3 months of age:

• bronchitis and pneumonia in patients with cystic fibrosis;
• severe bacterial infection of the brain (meningitis).

Meropenem AptaPharma can be used to treat bacterial infections of the blood, which may be associated with the above-mentioned types of infections.

2. Important information before using Meropenem AptaPharma

When not to use Meropenem AptaPharma

• if the patient is allergic to meropenem or 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, as the patient may also be allergic to meropenem.

Warnings and precautions

Before using Meropenem AptaPharma, the patient should inform their doctor, pharmacist, or nurse:

• if the patient has any health problems, such as liver or kidney disease;
• if the patient has had severe diarrhea after using other antibiotics.

During treatment, the patient may have a positive test result (so-called Coombs test) indicating the presence of antibodies that can destroy red blood cells. The doctor will discuss this with the patient.
The patient may experience objective and subjective symptoms of severe skin reactions (see section 4).
If the patient experiences such symptoms, they should immediately contact their doctor or nurse to start treatment for these symptoms.
If the patient has any doubts about whether any of the above situations apply to them, they should contact their doctor before taking Meropenem AptaPharma.

Children

Meropenem AptaPharma is not recommended for use in children under 3 months of age, as the safety and efficacy of meropenem in children under 3 months of age have not been established.

Meropenem AptaPharma and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Meropenem AptaPharma may affect the action of some medicines, and other medicines may affect the action of Meropenem AptaPharma.
In particular, the patient should tell their doctor or nurse if they are taking any of the following medicines:

• probenecid (used to treat gout);
• valproic acid and/or sodium valproate and/or valpromide (used to treat epilepsy). Meropenem AptaPharma should not be used, as it may reduce the effect of sodium valproate;
• oral anticoagulants (used to treat or prevent blood clots).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. It is recommended to avoid giving meropenem during pregnancy. The doctor will decide whether the patient should use meropenem.
If the patient is breastfeeding or plans to breastfeed, it is essential to inform their doctor before taking meropenem. Small amounts of this medicine pass into breast milk.
The doctor will decide whether to use meropenem in a breastfeeding woman.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.
However, the use of meropenem has been associated with headaches, tingling, and numbness (paresthesia), which may affect the ability to drive or use machines. Meropenem can also cause involuntary muscle movements, causing rapid and uncontrolled shaking of the whole body (seizures). This is usually accompanied by loss of consciousness.
If the patient experiences this side effect, they should not drive or use machines.

Meropenem AptaPharma contains sodium

Meropenem AptaPharma 2000 mg: this medicine contains 180 mg of sodium (the main component of common salt) per vial. This corresponds to 9% of the maximum recommended daily intake of sodium in the diet for adults.
The patient should discuss this with their doctor or pharmacist if they need to take 3 or more vials per day for an extended period, especially if they have been advised to follow a low-sodium diet.

3. How to use Meropenem AptaPharma

This medicine will be prepared and administered to the patient by a doctor or other qualified medical personnel. The doctor will decide how much Meropenem AptaPharma to give the patient.

Use in adults

• The dose of the medicine depends on the type of infection, its location in the body, and its severity. The doctor will decide on the dose needed by the patient.
• The usual dose for adults is between 500 mg (milligrams) and 2000 mg (2 grams). The medicine is usually given every 8 hours. However, the patient may receive the dose less frequently if their kidneys do not work properly.

Use in children and adolescents

• The dose of the medicine for children over 3 months to 12 years of age depends on the child's age and weight. The usual dose is between 10 mg and 40 mg of Meropenem AptaPharma per kilogram (kg) of the child's weight. The medicine is usually given every 8 hours. Children over 50 kg will receive the same dose as adults.

Other strengths of Meropenem AptaPharma and/or other meropenem-containing medicinal products may be available on the market, which are more suitable for dosing in children under 50 kg and adults with renal impairment.

How to use Meropenem AptaPharma

• Meropenem AptaPharma will be administered to the patient by infusion into a large vein.
• Meropenem AptaPharma will be administered by a doctor or nurse.
• The infusion solution should not be mixed or added to solutions containing other medicines.
• The infusion may last about 15-30 minutes.
• Usually, the infusion should be given daily at the same time.

Using a higher dose of Meropenem AptaPharma than recommended

If the patient thinks they may have accidentally received a higher dose of the medicine than recommended by their doctor, they should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Meropenem AptaPharma

If an infusion is missed, it should be given as soon as possible. However, if it is close to the time for the next infusion, the missed infusion should be skipped.
The patient should not take a double dose (two infusions at the same time) to make up for the missed dose.

Stopping the use of Meropenem AptaPharma

The patient should not stop using Meropenem AptaPharma unless their doctor decides to do so.
If the patient has any further doubts about using this medicine, they should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Meropenem AptaPharma can cause side effects, although not everybody gets them.

Severe allergic reactions

If any of these symptoms occur, the patient should immediatelycontact their doctor or nurse. The patient may urgently need medical attention.
The symptoms may include:

• severe rash, itching, or hives on the skin;
• swelling of the face, lips, tongue, or other parts of the body;
• difficulty breathing, wheezing, or breathing problems;
• severe skin reactions, which include: severe hypersensitivity reactions, including fever, skin rash, changes in blood test results indicating liver function (increased liver enzyme activity), and increased white blood cell count (eosinophils), as well as lymph node enlargement. These may be symptoms of a multi-organ hypersensitivity disorder known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or severe, red, flaky rash, skin nodules containing pus, blisters, or skin peeling, which may be associated with fever and joint pain; severe skin rashes, which may appear as red, round patches on the torso, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or, in more severe cases, [toxic epidermal necrolysis (Lyell's syndrome)].

Destruction of red blood cells(hemolytic anemia) [ not very common(may occur in less than 1 in 100 people)]
The symptoms may include:

• sudden shortness of breath;
• red or brown urine.

If the patient experiences any of these symptoms, they should immediatelycontact their doctor.

Other possible side effects:

Common (may occur in less than 1 in 10 people)

• abdominal pain, nausea, vomiting, diarrhea
• headache
• rash, itching
• inflammation and pain
• increased platelet count (visible in blood tests)
• changes in diagnostic test results indicating liver function

Uncommon (may occur in less than 1 in 100 people)

• blood changes, including decreased platelet count (which may cause easy bruising), increased white blood cell count, decreased white blood cell count, and increased bilirubin levels in the blood. Symptoms may include frequent infections, fever, and sore throat. From time to time, the doctor may recommend blood tests.
• changes in blood test results, including kidney function tests
• tingling sensation
• fungal infections of the mouth or vagina (thrush)
• inflammation of the intestines with diarrhea
• pain at the injection site, redness, and inflammation (thrombophlebitis)

Rare (may occur in less than 1 in 1000 people)

• seizures
• acute disorientation and confusion (delirium)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Meropenem AptaPharma

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the vial and the carton after "EXP". The expiry date refers to the last day of the month.
Store below 30°C.
Do not freeze the reconstituted solution.

Infusion

After reconstitution: the infusion solution should be administered immediately.
If meropenem is dissolved in 9 mg/mL (0.9%) sodium chloride solution for infusion, the time between the start of reconstitution and the end of intravenous infusion should not exceed:

• 3 hours at a temperature up to 25°C;
• 24 hours in a refrigerated state (2-8°C)

If meropenem is dissolved in 50 mg/mL (5%) glucose (dextrose) solution for infusion, the reconstituted solution should be administered immediately.
From a microbiological point of view, unless the method of opening and/or reconstitution precludes the risk of microbial contamination, the product should be used immediately.
If the product is not used immediately, the user is responsible for the storage conditions during use.
The solution should be inspected visually for particulate matter and discoloration prior to administration. Only a clear, colorless to yellow solution without particles should be used.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Meropenem AptaPharma contains

• The active substance of the medicine is meropenem. Each vial contains 2000 mg of meropenem (as 2280 mg of meropenem trihydrate).
• The other ingredients are sodium carbonate.

What Meropenem AptaPharma looks like and contents of the pack

Meropenem AptaPharma is a white to light yellow crystalline powder for solution for infusion, in glass vials.
After reconstitution, the product has the appearance of a clear, colorless to yellow solution.
Meropenem AptaPharma 2000 mg: a vial with a capacity of 50 mL made of colorless glass type I, with a stopper made of bromobutyl rubber type I and a green aluminum flip-off cap type with a PP overlay.
The pack contains 6 vials.

Marketing authorization holder

Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto
San Nicolò A Tordino
64100 Teramo
Italy

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

Advice/medical education

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 causes of such cases is the resistance of bacteria to the antibiotic used.
This means that despite the use of an antibiotic, some bacteria may survive or multiply.
There are many reasons for bacterial resistance. Proper use of antibiotics can reduce the likelihood of bacteria developing resistance.
When a doctor prescribes an antibiotic, it is intended to treat only the disease that the patient has at the time. By following the below guidelines, it is possible to prevent bacterial resistance that makes the antibiotic ineffective.

• 1. It is very important to use the antibiotic in the correct dose, at the correct times, and for the correct number of days. The patient should read the instructions in the patient information leaflet, and if they have any doubts, they should consult their doctor or pharmacist for clarification.
• 2. The patient should not use an antibiotic that has not been prescribed for them by a doctor, and they should only use it to treat the infection for which it was prescribed.
• 3. The patient should not use an antibiotic prescribed for another person, even if they have similar symptoms.
• 4. The patient should not pass on an antibiotic prescribed for them to other people.
• 5. The patient should return any unused antibiotic prescribed by their doctor to the pharmacy, which will dispose of it properly.

The following information is intended for medical personnel or healthcare professionals only

Preparation of infusion

Meropenem AptaPharma 2000 mg is intended only for intravenous infusion.
To prepare the infusion solution, the contents of the vial with meropenem should be dissolved in:

• 9 mg/mL (0.9%) sodium chloride solution for infusion or
• 50 mg/mL (5%) glucose (dextrose) solution for infusion to achieve a final concentration of 1 to 20 mg/mL.

During the preparation of the solution and its administration, standard aseptic conditions should be maintained.
The solution should be shaken before use. The solutions should be inspected visually for particulate matter and discoloration prior to administration. Only a clear, colorless to yellow solution without particles should be used.
The storage conditions for the product after reconstitution are described in section 5.