Meropenem Genoptim

Leaflet accompanying the packaging: patient information

Meropenem Genoptim, 500 mg, powder for solution for injection or infusion.
Meropenem Genoptim, 1 g, powder for solution for injection or 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.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

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

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

Meropenem Genoptim may be used to treat febrile neutropenic patients if a bacterial infection is suspected.
Meropenem Genoptim may be used to treat bacterial infections of the blood, which may be associated with the infections listed above.

2. Important information before using Meropenem Genoptim

When not to use Meropenem Genoptim

If the patient is allergic (hypersensitive) to meropenem or any of the other ingredients of the medicine (listed in section 6).
If the patient is allergic (hypersensitive) to other antibiotics, such as penicillins, cephalosporins, or carbapenems, as they may also be allergic to meropenem.

Warnings and precautions

Before using Meropenem Genoptim, consult a doctor, pharmacist, or nurse:

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

A positive Coombs test result may indicate 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 so that treatment for these symptoms can be started.

• If the patient experiences such symptoms, they should immediately contact their doctor or nurse so that treatment for these symptoms can be started.

In case of doubt, whether any of the above situations apply to the patient, they should inform their doctor or nurse before using Meropenem Genoptim.

Meropenem Genoptim and other medicines

Inform the doctor, pharmacist, or nurse about all medicines taken recently and those planned to be taken.
This is because Meropenem Genoptim may affect the way some medicines work, and some medicines may affect the way Meropenem Genoptim works.
In particular, inform the doctor, pharmacist, or nurse if the patient is taking:

Probenecid (used to treat gout);
Valproic acid, sodium valproate, or valpromide (used to treat epilepsy). Meropenem Genoptim should not be used, as it may reduce the effectiveness of sodium valproate.
Oral anticoagulants (used to treat or prevent the formation of blood clots in blood vessels).

Pregnancy and breastfeeding

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 administering meropenem to pregnant women.
The doctor will decide whether the patient should take Meropenem Genoptim.
It is essential to inform the doctor if the patient is breastfeeding or plans to breastfeed. Small amounts of the medicine may pass into breast milk. Therefore, the doctor will decide whether the patient should take Meropenem Genoptim while breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Meropenem Genoptim on the ability to drive and use machines.
Meropenem Genoptim has been associated with headaches, tingling, and numbness (paresthesia). Any of these side effects may affect the ability to drive or use machines.
Meropenem Genoptim may cause involuntary muscle contractions leading to 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 Genoptim contains sodium.

Meropenem Genoptim 500 mg. This medicine contains approximately 45 mg of sodium (a major ingredient used in cooking/table salt) per 500 mg dose. This is equivalent to 2.25% of the recommended maximum daily intake of sodium for an adult.
Meropenem Genoptim 1 g. This medicine contains approximately 90 mg of sodium (a major ingredient used in cooking/table salt) per 1 g dose. This is equivalent to 4.5% of the recommended maximum daily intake of sodium for an adult.
If the patient's health condition requires controlling the amount of sodium consumed, they should inform their doctor, pharmacist, or nurse.

3. How to use Meropenem Genoptim

Always use this medicine exactly as instructed by the doctor, pharmacist, or nurse. In case of doubt, consult the doctor, pharmacist, or nurse.

Use in adults

The dose of the medicine depends on the type of infection, the location of the infection in the body, and the severity of the infection. The doctor will decide on the appropriate dose for the patient.
The dose for adult patients is usually between 500 mg (milligrams) and 2 g (grams). The medicine is usually administered every 8 hours. However, in cases of kidney disorders, the medicine may be administered less frequently.

Use in children and adolescents

The dose of the medicine in children over 3 months and up to 12 years of age depends on the child's age and weight.
Usually, the dose is between 10 mg and 40 mg of Meropenem Genoptim per kilogram (kg) of the child's weight. The dose is usually administered every 8 hours. Children with a weight over 50 kg are given the same dose as adults.
How to use Meropenem Genoptim
The medicine will be administered to the patient into a large vein by injection or infusion.
The medicine will usually be administered by a doctor or nurse.
Some patients, parents, and caregivers are trained to administer Meropenem Genoptim at home. The administration instructions are included in this leaflet (in the section "Instructions for self-administration of Meropenem Genoptim at home"). Always use Meropenem Genoptim strictly according to the doctor's instructions. In case of doubt, consult the doctor.
The medicine should not be mixed or added to solutions containing other medicines.
Administration of the medicine may take about 5 minutes or from 15 to 30 minutes. The doctor will inform the patient how to administer Meropenem Genoptim.
The medicine is usually administered at the same time every day.

Using a higher dose of Meropenem Genoptim than recommended

If a higher dose of the medicine than recommended by the doctor is used, the patient should immediately contact their doctor or go to the nearest hospital.

Missing a dose of Meropenem Genoptim

If a dose of the medicine is missed, it should be administered as soon as possible. However, if the time to the next dose is short, the missed dose should be skipped.
A double dose (two injections at the same time) should not be administered to make up for the missed dose.

Stopping the use of Meropenem Genoptim

The use of Meropenem Genoptim should not be stopped unless the doctor recommends it.
In case of any further doubts about the use of the medicine, consult the doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe allergic reactions

If the patient experiences any of these symptoms, they should immediately contact their doctor or nurse. The patient may need urgent 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 shortness of breath,
• severe skin reactions, including:

• severe hypersensitivity reactions, including fever, skin rash, changes in liver function test results, and increased levels of a certain type of white blood cell (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);
• severe, red, blistering skin rash, skin lesions containing pus, blisters, or peeling of the skin, which may be associated with fever and joint pain;
• severe skin reactions, which may appear as red, round patches on the torso, often with blisters in the center, 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 in a more severe form [toxic epidermal necrolysis (Lyell's syndrome)].

Destruction of red blood cells (frequency not known)

Symptoms include:
sudden shortness of breath;
red or brown urine.
If any of these symptoms occur, the patient should immediately contact their doctor.

Other possible side effects

Common (may affect up to 1 in 10 people)

abdominal pain (stomach);
nausea;
vomiting;
diarrhea;
headache;
skin rash, itching;
pain and inflammation;
increased platelet count (in laboratory tests);
changes in blood test results, including liver function tests.

Uncommon (may affect up to 1 in 100 people)

changes in blood, including decreased platelet count (which may lead to easy bruising), increased levels of certain white blood cells, decreased levels of other white blood cells, increased levels of a substance called bilirubin; the doctor may recommend regular 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 in the veins at the injection site;
other changes in blood. Symptoms include frequent infections, fever, and sore throat. From time to time, the doctor may recommend regular blood tests;

Rare (may affect up to 1 in 1000 people)

seizures (convulsions),
acute confusion and disorientation (delirium).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Meropenem Genoptim

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after "EXP". The expiry date refers to the last day of the month.
After reconstitution: the prepared solution for injection or infusion should be used immediately. The time between the start of reconstitution and the end of administration should not exceed one hour.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
If not used immediately, the storage times and conditions are the responsibility of the user.
Do not freeze the prepared solution.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Meropenem Genoptim contains

• The active substance of the medicine is meropenem. Meropenem Genoptim 500 mg: each vial contains 500 mg of anhydrous meropenem in the form of meropenem trihydrate. Meropenem Genoptim 1 g: each vial contains 1 g of anhydrous meropenem in the form of meropenem trihydrate.
• Other ingredients are sodium carbonate.

What Meropenem Genoptim looks like and contents of the pack

Meropenem Genoptim is a white to light yellow powder for solution for injection or infusion, in glass vials. The pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer:
Pharmathen S.A.
6 Dervenakion Str., 15351 Pallini, Attikis
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Ireland: Meropenem 500 mg Powder for Solution for Injection or Infusion,
Meropenem 1000 mg Powder for Solution for Injection or Infusion
Iceland: Meropenem Portfarma 500 mg, Meropenem Portfarma 1000 mg
Poland: Meropenem Genoptim, 500 mg powder for solution for injection or infusion.
Meropenem Genoptim, 1 g, powder for solution for injection or infusion.

Date of last revision of the leaflet: 04.2022

Medical information

Antibiotics are used to treat infections caused by bacteria. They are ineffective in treating infections caused by viruses.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this phenomenon is the resistance of the bacteria causing the infection to the antibiotic used. This means that the bacteria can survive and even multiply despite the use of the antibiotic.
Bacteria can develop resistance to antibiotics for various reasons. The responsible use of antibiotics can reduce the risk of developing bacterial resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following recommendations will help prevent the emergence of resistant bacteria, which would render the antibiotic ineffective.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct number of days. Read the instructions in the leaflet and, in case of doubt, ask the doctor or pharmacist for clarification.
• 2. Do not use an antibiotic that has not been prescribed specifically for the patient, and use it only for the treatment of the infection for which it was prescribed.
• 3. Do not take antibiotics prescribed for another person, even if they had a similar infection.
• 4. Do not pass on antibiotics prescribed for the patient to other people.
• 5. If there are any leftover antibiotics after completing the prescribed treatment cycle, take them to a pharmacy for proper disposal.

Information intended only for healthcare professionals:

Instructions for self-administration of Meropenem Genoptim at home

Some patients, parents, and caregivers may be trained to administer Meropenem Genoptim at home.

Warning - The medicine can only be self-administered at home after prior training by a doctor or nurse.

How to prepare the medicine

This medicine must be mixed with another liquid (diluent). The doctor will inform the patient how much diluent to use.
The medicine should be administered immediately after preparation. Do not freeze it.

• 1. Wash and dry hands thoroughly. Prepare a clean workspace.
• 2. Remove the vial of Meropenem Genoptim from the packaging. Check the vial and expiration date. Check if the vial is damaged or shows signs of tampering.
• 3. Remove the colored cap and wipe the gray rubber stopper with an alcohol swab. Wait until the stopper is dry.
• 4. Connect a new, sterile needle to a new, sterile syringe, without touching their ends.
• 5. Draw the prescribed volume of sterile "Water for Injections" into the syringe. The required volume of water is indicated in the table below:

Note.If the prescribed dose of Meropenem Genoptim is more than 1 g, more than one vial of Meropenem Genoptim will be needed. In this case, the liquid can be drawn from several vials into one syringe.

• 6. Insert the needle of the syringe through the center of the rubber stopper and add the prescribed volume of water for injections to the vial or vials of Meropenem Genoptim.
• 7. Remove the needle from the vial and shake the vial for about 5 seconds or until the powder is dissolved. Then, wipe the rubber stopper with a new alcohol swab and wait until it is dry.
• 8. With the syringe plunger fully depressed, reinsert the needle through the rubber stopper. Hold both the syringe and the vial and turn the vial upside down.
• 9. Holding the needle tip immersed in the solution, pull the syringe plunger to draw the entire solution from the vial into the syringe.
• 10. Remove the needle and syringe from the vial and discard the empty vial in a safe place.
• 11. Hold the syringe vertically, with the needle pointing upwards. Tap the syringe to make any air bubbles rise to the top.
• 12. Remove the air from the syringe by gently pressing the plunger until all the air is removed.
• 13. If Meropenem Genoptim is used at home, the used needles and infusion set should be disposed of properly. If the doctor decides to discontinue treatment, any unused Meropenem Genoptim should be disposed of in accordance with local regulations.

Administering the medicine

The medicine can be administered through a short cannula or venflon, or through a port or central access.

Administering Meropenem Genoptim through a short cannula or venflon

• 1. Remove the needle from the syringe and carefully discard it in a sharps container.
• 2. Wipe the end of the cannula or venflon with an alcohol swab and wait until it is dry. Remove the cap from the cannula and connect the syringe.
• 3. Slowly press the syringe plunger to administer the antibiotic evenly over about 5 minutes.
• 4. After completing the administration of the antibiotic and emptying the syringe, disconnect the syringe and flush the cannula according to the doctor's or nurse's instructions.
• 5. Close the cannula and carefully discard the syringe in a sharps container.

Administering Meropenem Genoptim through a port or central access

• 1. Remove the cap from the port or central access, clean the end of the access with an alcohol swab, and wait until it is dry.
• 2. Connect the syringe and slowly press the plunger to administer the antibiotic evenly over about 5 minutes.
• 3. After completing the administration of the antibiotic, disconnect the syringe and flush the line according to the doctor's or nurse's instructions.

• 4. Put a new, clean cap on the central access and carefully discard the syringe in a sharps container.

Administering Meropenem Genoptim through intravenous infusion

Meropenem Genoptim is usually administered by intravenous infusion over 15 to 30 minutes.
To prepare meropenem for intravenous infusion, the contents of the vial can be dissolved directly in 0.9% sodium chloride solution or 5% glucose solution for infusion, to obtain a concentration of 1 to 20 mg/mL.
The solution should be shaken before use.
Before administration, check that the solution does not contain any undissolved particles.
Only a clear, light yellow solution without visible particles should be used.
Each vial is for single use only.