Meropenem genoptim

Patient Information Leaflet

Meropenem Genoptim, 500 mg, powder for solution for injection or infusion.
Meropenem Genoptim, 1 g, powder for solution for injection or infusion.
Meropenemum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

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

Leaflet Contents

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

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

Meropenem Genoptim contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. This medicine works by killing bacteria that may cause serious 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 intra-abdominal infections.
• Infections that may occur during or after childbirth.
• Complicated skin and soft tissue infections.
• Acute bacterial meningitis (infection of the membranes surrounding the brain).

Meropenem Genoptim may be used to treat febrile patients with neutropenia when a bacterial infection is suspected.
Meropenem Genoptim may also be used to treat bacterial bloodstream infections that 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 to 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, because 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 previously experienced severe diarrhoea after taking other antibiotics.

A positive Coombs test 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 such symptoms occur, the patient should contact a doctor or
nurse immediately so that treatment for these symptoms can be initiated.
If in doubt whether any of the above situations apply to the patient, the patient should inform the doctor or nurse before
using Meropenem Genoptim.

Meropenem Genoptim and other medicines
The patient should tell the doctor, pharmacist, or nurse about all medicines they are currently taking or
intend to take.
This is because Meropenem Genoptim may affect the way some medicines work, and some medicines may affect the action of Meropenem Genoptim.
In particular, inform the doctor, pharmacist, or nurse if the patient is taking
the following medicines:
Probenecid (used in the treatment of gout);
Valproic acid, sodium valproate, or valpromide (used in the treatment of epilepsy). Meropenem Genoptim should not be used, as it may reduce the effectiveness of sodium valproate.
Oral anticoagulants (used in the treatment or prevention of blood clots in blood vessels).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, 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 to pregnant patients.
The decision on whether the patient should receive Meropenem Genoptim will be made by the doctor.
It is important to inform the doctor before administering meropenem 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 use Meropenem Genoptim during breastfeeding.

Driving and operating machinery
Studies on the influence on the ability to drive motor vehicles and operate
machinery have not been conducted.
Use of Meropenem Genoptim has been associated with headache, prickling sensations, and numbness
(paresthesia). Any of these adverse effects may affect the ability to drive
or operate machinery.
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 adverse effect, they should not drive or operate
machinery.

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

3. How to use Meropenem Genoptim

Always use this medicine exactly as instructed by your doctor, pharmacist, or nurse. If you have any doubts, please consult your doctor, pharmacist, or nurse.
Use in adults
The dose depends on the type of infection, its location in the body, and the severity of the infection. Your doctor will decide the appropriate dose for you.
The usual dose for adult patients ranges from 500 mg (milligrams) to 2 g (grams). The medicine is usually administered every 8 hours. However, if you have impaired kidney function, the medicine may be given less frequently.
Use in children and adolescents
The dose for children over 3 months of age up to 12 years depends on the child's age and body weight. The usual dose is 10 mg to 40 mg of Meropenem Genoptim per kilogram (kg) of body weight. The dose is usually given every 8 hours. Children weighing more than 50 kg receive the same dose as adults.
How to use Meropenem Genoptim
Meropenem Genoptim will be administered into a large vein by injection or infusion.
Meropenem Genoptim is usually given by a doctor or nurse.
Some patients, parents, and caregivers are trained to administer Meropenem Genoptim at home. Instructions for self-administration are included in this leaflet (in the section "Instructions for self-administering Meropenem Genoptim at home to yourself or another person"). Always use Meropenem Genoptim strictly according to your doctor's instructions. If in doubt, consult your doctor.
Do not mix this medicine with, or add it to, solutions containing other medicines.
Administration may take approximately 5 minutes or from 15 to 30 minutes. Your doctor will inform you how Meropenem Genoptim should be administered.
The medicine is usually given at the same time each day.
Use of a higher than recommended dose of Meropenem Genoptim
If you accidentally use more medicine than prescribed, contact your doctor immediately or go to the nearest hospital.
Missed dose of Meropenem Genoptim
If you miss an injection, administer it as soon as possible. However, if the time until the next scheduled dose is short, skip the missed dose.
Do not administer a double dose (two injections at the same time) to make up for a missed dose.
Stopping treatment with Meropenem Genoptim
Do not stop using Meropenem Genoptim unless instructed by your doctor.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Severe allergic reactions
If any of the following subjective or objective symptoms occur in the patient, immediately contact a doctor or nurse. The patient may urgently require medical assistance. Objective and subjective symptoms may include sudden onset of:
severe rash, itching or hives on the skin,
swelling of the face, lips, tongue or other body parts,
shortness of breath, wheezing or difficulty breathing,
severe skin reactions including:

• severe hypersensitivity reactions including fever, skin rash, changes in blood test results used to assess liver function (increased liver enzyme activity), increased levels of a certain type of white blood cells (eosinophils), and 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, 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 eye ulcers, 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)].

Damage to red blood cells (frequency unknown)
Symptoms include:
sudden onset of breathlessness;
red or brown discoloration of urine.
If any of the above symptoms occur, immediately contact a doctor.
Other possible adverse reactions
Common (may occur in up to 1 in 10 people)
abdominal (stomach) pain;
nausea;
vomiting;
diarrhea;
headache;
rash, skin itching;
pain and inflammation;
increased platelet count (in laboratory tests);
changes in blood laboratory test results, including tests assessing liver function.
Uncommon (may occur in up to 1 in 100 people)
blood changes 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 tests assessing kidney function;
tingling sensation;
fungal infections of the mouth or vagina (thrush);
intestinal inflammation with diarrhea;
vein pain at the site of Meropenem Genoptim administration;
other blood changes. Symptoms include frequent infections, fever, and sore throat. Occasionally, the doctor may recommend regular blood tests;
Rare (may occur in up to 1 in 1000 people)
seizures (convulsions),
acute disorientation and confusion (delirium).
Reporting of adverse reactions
If any adverse reactions occur, including any 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 Warsaw
tel.: +48 22 49 21 301
fax.: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Meropenem Genoptim

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
on the vial label after "EXP". The expiry date refers to the last day of the specified month.
After reconstitution: the prepared solution for intravenous injection or infusion should be used
immediately. The time between the start of reconstitution and the end of administration of the
injection or infusion should not exceed one hour.
From a microbiological standpoint, unless the method of opening / reconstituting / diluting
excludes the risk of microbiological contamination, the product should be used immediately.
If not used immediately after preparation, the duration and conditions of storage are the
responsibility of the user.
Do not freeze the prepared solution.
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. Contents of the pack and other information

What Meropenem Genoptim contains

• The active substance is meropenem.
  Meropenem Genoptim 500 mg: Each vial contains 500 mg of anhydrous meropenem as meropenem trihydrate.
  Meropenem Genoptim 1 g: Each vial contains 1 g of anhydrous meropenem as meropenem trihydrate.
• Other ingredients: sodium carbonate.

What Meropenem Genoptim looks like and contents of the pack
Meropenem Genoptim is a white to pale 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa, Poland

Manufacturer:
Pharmathen S.A.
6 Dervenakion Str., 15351 Pallini, Attikis, Greece

This medicinal product is authorised in the European Economic Area countries 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.

Medical advice

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 is that the bacteria causing the infection are resistant to the antibiotic used. This means that bacteria can survive and even multiply despite the use of the antibiotic.
Bacteria may exhibit resistance to antibiotics for various reasons. Prudent use of antibiotics can reduce the risk of development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following recommendations will help prevent the emergence of resistant bacteria, which could lead to antibiotics becoming ineffective.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Please read the instructions in the leaflet and, if in doubt, ask your doctor or pharmacist for clarification.
2. Do not use an antibiotic that has not been specifically prescribed for you, and use it only to treat 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 give away antibiotics prescribed for you to other people.
5. If any unused antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy for proper disposal.

Information intended exclusively for healthcare professionals:

Instructions for self-administration of Meropenem Genoptim at home to yourself or another person
Some patients, parents, and caregivers may be trained to administer Meropenem Genoptim at home.
Warning – This medicine may only be self-administered to yourself or another person at home 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 inform you how much
diluent to use.
The medicine should be administered immediately after preparation. Do not freeze.

1. Wash and dry your hands thoroughly. Prepare a clean working area.
2. Remove the Meropenem Genoptim vial from its packaging. Check the vial and the expiration date. Ensure the vial is intact and shows no signs of damage.
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 ends.
5. Draw into the syringe the recommended volume of sterile “Water for Injections”. The required volume of water is indicated in the table below:

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

6. Insert the syringe needle through the center of the rubber stopper and add the recommended volume of water for injection to the vial or vials containing Meropenem Genoptim.
7. Remove the needle from the vial and shake the vial for approximately 5 seconds or until the powder is completely dissolved. Wipe the rubber stopper again with a new alcohol-impregnated swab and wait for the stopper to dry.
8. With the syringe plunger fully depressed, reinsert the needle through the gray rubber stopper. Hold both the syringe and the vial, then invert the vial upside down.
9. Keeping the tip of the needle submerged in the solution, pull back the syringe plunger to draw the entire solution from the vial into the syringe.
10. Remove the needle and syringe from the vial and dispose of the empty vial in a safe manner.
11. Hold the syringe in an upright, vertical position with the needle pointing upward. Gently tap the syringe to allow air bubbles to rise to the top.
12. Remove air from the syringe by gently depressing the plunger until all air has been expelled.
13. If Meropenem Genoptim is being used at home, used needles and infusion sets must be disposed of properly. If the physician decides to discontinue treatment, any unused Meropenem Genoptim should be discarded according to local regulations.

Administration of the Medicinal Product
The medicinal product can be administered via a short cannula or venflon, or through a port or central venous access.
Administration of Meropenem Genoptim via a short cannula or venflon

1. Remove the needle from the syringe and carefully dispose of it in a sharps container.
2. Wipe 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 syringe plunger to administer the antibiotic evenly over approximately 5 minutes.
4. After completing the antibiotic administration 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 Genoptim via port or central venous access

1. Remove the cap from the port or central venous access, clean the access site 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 administration, disconnect the syringe and flush the line as directed by the physician or nurse.
4. Apply a new sterile cap to the central venous access and carefully dispose of the syringe in a sharps container.

Administration of Meropenem Genoptim by 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 may be dissolved
directly in 0.9% sodium chloride solution or 5% glucose solution for infusion to achieve
a concentration of 1 to 20 mg/mL.
The solution should be shaken before use.
Before administration, check that no undissolved particles are present in the solution.
Only a clear, pale yellow solution free from visible particles should be used.
Each vial is for single use only.