Meropenem Steriscience B.V.

Package leaflet: Information for the user

Meropenem Steriscience B.V. 2 g powder for solution for injection/infusion

meropenem
Please read 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Meropenem Steriscience B.V. is and what it is used for

Meropenem Steriscience B.V. 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.
Meropenem Steriscience B.V. is used to treat the following infections in adults and children aged at least 3 months:

• Lung infection (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 infection of the brain (meningitis)

Meropenem Steriscience B.V. can be used in the management of febrile neutropenic patients in whom a bacterial infection is suspected.
Meropenem Steriscience B.V. can be used to treat bacterial blood infections that may be associated with one of the above-mentioned types of infection.

2. What you need to know before using Meropenem Steriscience B.V.

Do not use Meropenem Steriscience B.V.

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

Warnings and precautions
Consult your doctor, pharmacist, or nurse before using Meropenem Steriscience B.V. if:

• you have health problems, such as liver or kidney problems;
• you have previously experienced 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). In such a case, seek immediate medical advice from your doctor or nurse to treat the symptoms.
If you are unsure whether any of these conditions apply to you, discuss them with your doctor or nurse before using Meropenem Steriscience B.V.
Other medicines and Meropenem Steriscience B.V.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Meropenem Steriscience B.V. can affect how some medicines work, and some medicines can affect Meropenem Steriscience B.V.
In particular, inform your doctor, pharmacist, 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 Steriscience B.V. must not be used, as it may reduce the effect of sodium valproate.
• Oral anticoagulants (used to treat or prevent blood clots).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine. It is preferable to avoid using meropenem during pregnancy. Your doctor will decide whether to use Meropenem Steriscience B.V.
It is important to inform your doctor if you are breastfeeding or intend to breastfeed before receiving meropenem. Small amounts of this medicine may pass into breast milk.
Therefore, your doctor will need to decide whether you can use Meropenem Steriscience B.V. while breastfeeding.
Driving and using machines
No studies have been conducted on the effect on the ability to drive or use machines.
Meropenem Steriscience B.V. has been associated with headache and tingling or pricking sensations of the skin (paraesthesia).
Each of these side effects could impair your ability to drive or use machinery.
Meropenem Steriscience B.V. may cause involuntary muscle movements that may make the body shake rapidly and uncontrollably (seizures). This is usually accompanied by loss of consciousness. Do not drive or operate machinery if you experience these side effects.
Meropenem Steriscience B.V. contains sodium
This medicine contains 180.4 mg of sodium (7.843 mmol sodium/vial) (the main component of table salt) in each vial. This corresponds to 9% of the maximum daily recommended sodium intake for an adult.
If you have a condition that requires monitoring of sodium intake, inform your doctor, pharmacist, or nurse.

3. How to use Meropenem Steriscience B.V.

Use this medicine exactly as described in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts, 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.
• The usual dose for adults ranges from 500 mg (milligrams) to 2,000 mg (milligrams). The dose is usually administered every 8 hours. However, if your kidneys are not functioning properly, the dosing frequency may be reduced.

Use in children and adolescents

• The dose for children aged over 3 months up to 11 years is determined based on the child's age and weight. The usual dose ranges from 10 to 40 mg of meropenem per kilogram (kg) of body weight. The dose is usually given every 8 hours. Children weighing more than 50 kg should receive an adult dose.

How to use Meropenem Steriscience B.V.

• Meropenem Steriscience B.V. is administered as an injection/infusion into a large vein.
• Normally, the doctor or nurse will administer the medicine.
• However, some patients, parents, or caregivers may be trained to administer Meropenem Steriscience B.V. at home. Instructions for this are provided in this leaflet (in the section titled "Instructions for administering Meropenem Steriscience B.V. to yourself or to another person at home"). Always use Meropenem Steriscience B.V. exactly as instructed by your doctor. If you have any doubts, consult your doctor.
• The injection must not be mixed with or added to solutions containing other medicines.
• The injection may last approximately 5 minutes or between 15 and 30 minutes. Your doctor will instruct you on how to administer Meropenem Steriscience B.V.
• Injections should normally be given at the same time each day.

If you use more Meropenem Steriscience B.V. than you should
If you accidentally use more than the prescribed dose, contact your doctor or the nearest hospital immediately.

If you forget to use Meropenem Steriscience B.V.
If you forget to give an injection, do so as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose (or give two injections at the same time) to make up for a forgotten dose.

If you stop using Meropenem Steriscience B.V.
Do not stop treatment with Meropenem Steriscience B.V. unless instructed by your doctor.

If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious allergic reactions
If any of the following signs or symptoms occur, inform your doctor or nurse immediately. You may
require 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.
• Serious skin reactions that may be life-threatening include:
• Severe hypersensitivity reactions involving fever, skin rash, blood test abnormalities affecting liver function (increased liver enzyme levels), 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.
• Severe red, scaly skin rash, skin lesions containing pus, blisters or skin peeling, which may be associated with high fever and joint pain.
• Severe skin rashes 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).

Damage to red blood cells (frequency not known)
Signs include:

• Unexpected shortness of breath.
• Red or brown urine. If you notice any of these symptoms, consult a doctor immediately.

Other possible side effects:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Blood disorders. These include reduced platelet count (which may make bruising easier), increased levels of certain white blood cells, decreased levels of other white blood cells, and increased levels of a substance called "bilirubin". Your doctor may perform blood tests from time to time.
• Changes in blood tests, including those indicating kidney function
• A tingling sensation (pins and needles)
• Mouth or vaginal fungal infections (candidiasis)
• Inflammation of the intestine with diarrhoea
• Pain in the veins where Meropenem Steriscience B.V. is injected
• Other blood disorders. Symptoms include frequent infections, fever and sore throat. Your doctor may perform blood tests from time to time.

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at 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 Steriscience B.V.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After preparation of the ready-to-use solution:
Ready-to-use solutions for intravenous injection or infusion must be used immediately. The time between the start of preparation of the ready-to-use solution and the end of intravenous injection or infusion depends on the solvent used. Chemical and physical in-use stability has been demonstrated as shown in the table below.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the duration and conditions of storage are the responsibility of the user.
Do not freeze the ready-to-use solution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines. These measures will help protect the environment.

6. Package contents and other information

What Meropenem Steriscience B.V. contains
The active substance is meropenem.
Each vial contains 2 g of meropenem (as meropenem trihydrate).
The other component is sodium carbonate.

Description of the appearance of Meropenem Steriscience B.V. and contents of the pack
Meropenem Steriscience B.V. is a white to pale yellow powder for injectable/infusion solution, contained in a vial.
Pack size: 1 vial.

Marketing Authorization Holder
Steriscience B.V.
Kranenburgweg 135-A
2583 ER The Hague
The Netherlands

Manufacturer
Unifarma SIA
Vangazu street 23, Riga, LV-1024, Latvia

This medicinal product is authorized in the European Economic Area member states under the following names:

| Member States | Proposed Product Names | |-------------------|----------------------------| | Germany | Meropenem Steriscience 2 g Powder for solution for injection/infusion | | France | Meropenem Steriscience B.V. 2 g powder for injectable solution or infusion | | Italy | Meropenem Steriscience B.V. 2 g powder for injectable solution or infusion | | Spain | Meropenem Steriscience 2 g powder for injectable solution or perfusion |

Medical advice/education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes, bacterial infections do not respond to a course of antibiotics. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic taken. This means they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the likelihood of bacteria becoming resistant.

When a doctor prescribes a course of antibiotics, the aim is to treat only the current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could render antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the right times, and for the correct number of days. Read the instructions on the label, and if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only to treat the infection for which it was prescribed.
3. Do not take antibiotics that have been prescribed for other people, even if they had an infection similar to yours.
4. Do not give other people the antibiotics prescribed for you.
5. If, after completing the prescribed course of antibiotics as directed by your doctor, you have leftover medication, return it to a pharmacy for proper disposal.

The following information is intended exclusively for healthcare professionals:
For complete information on dosage, warnings and precautions, instructions for reconstitution of the medicine before administration, etc., refer to the Summary of Product Characteristics.

Instructions for administering Meropenem Steriscience B.V. to oneself or to others at home
Some patients, parents, and caregivers are trained to administer Meropenem Steriscience B.V. at home.

Warning – Administer this medicine to yourself or someone else at home only after receiving proper training from a doctor or nurse.

How to prepare this medicine

• The medicine must be mixed with another liquid (the diluent). Your doctor will indicate the amount of diluent to use.
• Use the medicine immediately after preparation. Do not freeze.

1. Wash your hands thoroughly and dry them well. Prepare a clean workspace.
2. Remove the Meropenem Steriscience B.V. vial (bottle) from its packaging. Check the vial and the expiration date. Ensure the vial is intact and has not been damaged.
3. Remove the colored cap and clean the grey rubber stopper with an alcohol wipe. Allow the rubber stopper to dry.
4. Attach a new sterile needle to a new sterile syringe, taking care not to touch the connecting ends.
5. Draw up the recommended amount of sterile "Water for Injections" into the syringe. The amount of liquid required is indicated in the table below:

Note: If the prescribed dose of meropenem exceeds 1 g, it is necessary to use more than one vial of
Meropenem 500 mg or 1 g, or a single 2 g vial may be used. The liquid from the vials can then be drawn
into a single syringe.

6. Insert the needle of the syringe through the center of the grey rubber stopper and inject the recommended amount of Water for Injections into the vial or vials of Meropenem Steriscience B.V.
7. Remove the needle from the vial and shake the vial well for about 5 seconds, or until all the powder has dissolved. Clean the grey rubber stopper once again with a new alcohol swab and allow the rubber stopper to dry.
8. With the plunger fully inserted into the syringe, reinsert the needle through the grey rubber stopper. Hold both the syringe and the vial firmly with one hand and invert the vial.
9. Keeping the tip of the needle immersed in the liquid, pull back the plunger to draw all the liquid from the vial into the syringe.
10. Remove the needle and syringe from the vial and dispose of the empty vial in a safe place.
11. Hold the syringe vertically with the needle pointing upwards. Tap the syringe gently so that any air bubbles rise to the top of the syringe.
12. Expel the air from the syringe by gently pushing the plunger until no air remains.
13. If Meropenem Steriscience B.V. is used at home, dispose of used needles and infusion lines appropriately. If the doctor decides to discontinue treatment, dispose of any unused Meropenem Steriscience B.V. appropriately.

Administration of the injection
The medicine can be administered via a short cannula or venflon, or through a port or central venous catheter.
Administration of Meropenem Steriscience B.V. 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 short cannula or venflon with an alcohol swab and allow it to dry. Remove the cap from the cannula and attach the syringe.
3. Slowly push the syringe plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
4. At the end of the antibiotic administration, when the syringe is empty, remove the syringe and perform a flush as recommended by the doctor or nurse.
5. Replace the cap on the cannula and carefully dispose of the syringe in a sharps container.

Administration of Meropenem Steriscience B.V. via port or central line

1. Remove the cap from the port or catheter, clean the catheter end with an alcohol swab, and allow it to dry.
2. Attach the syringe and slowly push the syringe plunger to administer the antibiotic at a steady rate over approximately 5 minutes.
3. After completion of antibiotic administration, remove the syringe and perform a flush as recommended by the doctor or nurse.
4. Attach a new clean cap to the central venous catheter and carefully dispose of the syringe in a sharps container.

The following information is intended for healthcare professionals only. For complete prescribing
information, refer to the SmPC.
Dosage and method of administration
Dosage
The tables below provide general dosage recommendations.
The dose of meropenem administered and the duration of treatment should take into account the type of
infection being treated, including its severity, and the clinical response.
For administration of doses less than 2 g, use of the 500 mg and 1,000 mg formulations is recommended.
A dose of up to 2 g three times daily in adults and adolescents and up to 40 mg/kg three times daily in children may be particularly appropriate for the treatment of certain types of infections, such as those caused by less susceptible bacterial species (e.g. Enterobacterales, Pseudomonas aeruginosa, Acinetobacter spp.) or very severe infections.
Additional dosage considerations are required when treating patients with renal impairment (see below).
Administration instructions related to dose should be taken into account, particularly when using a 2 g dose in adults/adolescents or a 40 mg/kg dose in children (see Method of administration).
Adults and adolescents

Route of administration
For intravenous use.
After reconstitution, Meropenem Steriscience B.V. is usually administered by intravenous infusion over approximately 15–30 minutes. Alternatively, doses up to 1 g of meropenem may be given as an intravenous bolus injection lasting about 5 minutes. Limited data are available on the safety of administering a 2 g dose in adults as an intravenous bolus injection.

Renal impairment
The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as indicated below. Limited data are available to support the application of these dose adjustments for a single dose of 2 g.

Meropenem Steriscience B.V. is removed by haemodialysis and haemofiltration. The required dose
should be administered after completion of the dialysis session.
There are no established recommendations for dosing in patients undergoing peritoneal dialysis.
Hepatic impairment
No dose adjustment is required in patients with hepatic impairment (see section 4.4).
Dosing in elderly patients
No dose adjustment is required in elderly patients with normal renal function or creatinine clearance values
greater than 50 mL/min.
Paediatric population
Children under 3 months of age
The safety and efficacy of meropenem in children under 3 months of age have not been established, and the optimal dosing regimen has not been identified. However, limited pharmacokinetic data suggest that a regimen of 20 mg/kg every 8 hours may be appropriate (see section 5.2).
Children from 3 months to 11 years of age and weighing up to 50 kg
The recommended dosage regimens are shown in the following table:

Children with body weight greater than 50 kg
The adult dose should be administered.
There is no experience in children with renal impairment.

Method of administration
For intravenous use only.
After reconstitution, Meropenem Steriscience B.V. is usually administered by intravenous infusion over approximately 15–30 minutes. Alternatively, doses of meropenem up to 20 mg/kg may be given as an intravenous bolus injection over approximately 5 minutes. Limited safety data are available to support administration of a 40 mg/kg dose in children as an intravenous bolus injection.

Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in the section "Special precautions for disposal and other handling".

Special precautions for disposal and handling
Preparation of the injectable solution (as bolus injection)
Meropenem Steriscience B.V. must be reconstituted with sterile water for injections. The bolus injectable solution is prepared by dissolving the powder in sterile water for injections to a final concentration of 50 mg/mL.

Preparation of the infusion solution
The powder may be reconstituted directly with 9 mg/mL (0.9%) sodium chloride solution or 50 mg/mL (5%) glucose solution for infusion. Each vial is for single use only. The reconstituted solution must be prepared aseptically. The solution should be shaken before use.

Instructions for preparation of the medicinal product

1. Wash and thoroughly dry hands. Clean the work area.
2. Remove one vial of Meropenem Steriscience B.V. 2 g from the package. Check the vial and the expiration date. Ensure the vial is intact and has not been damaged.
3. Remove the coloured cap and clean the grey rubber stopper with an alcohol-impregnated cloth. Allow the rubber stopper to dry.
4. Insert a sterile needle into a new sterile syringe without touching the connecting ends.
5. Withdraw 40 mL of sterile "water for injections" into the syringe. The powder in one vial should be reconstituted with 40 mL of water for injections.

Note: The required dose may then be withdrawn from the vial into a single syringe.

6. Insert the syringe needle through the centre of the rubber stopper and inject the recommended volume of "water for injections" into the vial or vials of Meropenem Steriscience B.V. 2 g.
7. Remove the needle from the vial and shake the vial well for about 5 seconds or until all the powder is dissolved. Clean the rubber stopper again with an alcohol-impregnated cloth. Allow the rubber stopper to dry.
8. Push the plunger of the syringe fully in, then reinsert the needle through the grey rubber stopper. Invert the vial, holding the syringe and vial together.
9. Ensure the tip of the needle remains immersed in the liquid and pull back the plunger. In this way, withdraw all the liquid from the vial into the syringe.
10. Remove the syringe from the vial and dispose of the empty vial in a safe place.
11. Hold the syringe in an upright position with the needle pointing upwards. Gently tap the syringe so that any air bubbles rise to the top of the syringe.
12. Expel air from the syringe by gently pushing the plunger upwards until all air has been expelled.

Note:
Intravenous infusion of meropenem may be administered directly using 9 mg/mL (0.9%) sodium chloride or 50 mg/mL (5%) glucose in infusion solution. Follow the instructions below:
Add 40 mL of infusion solution to a vial, shake the reconstituted solution well, and then transfer it into the infusion bag. The final infusion solution contains the following concentrations.

Appearance of the reconstituted solution
The reconstituted solution should be clear to pale yellow transparent and free of visible particles.
Each vial is for single use only.
NOTE: The vial must be brought to room temperature before opening.
Standard aseptic techniques must be used for the preparation and administration of the solution.
The solution should be shaken before use.
Unused medicines and waste materials must be disposed of in accordance with local requirements.

Injection administration
The medicine may be administered through a short cannula or an indwelling venous catheter, or through an implanted port or central access.

Administration of Meropenem through a short cannula or an indwelling venous catheter

1. Remove the needle from the syringe and carefully insert it into the syringe container.
2. Clean the end of the short cannula or indwelling venous catheter with an alcohol-impregnated wipe and allow it to dry. Open the cannula cap and connect the cannula to the syringe.
3. Slowly push the plunger to evenly administer the antibiotic over a period of 5 minutes.
4. After completion of antibiotic administration and once the syringe is empty, remove the syringe and flush the cannula as directed by the physician or as recommended for healthcare professionals.
5. Close the cannula cap and carefully dispose of the syringe in the sharps container.

Administration of Meropenem through an implanted venous port or central venous access

1. Remove the port or access cap, clean the access end with an alcohol-impregnated wipe, and allow it to dry.
2. Connect the syringe and slowly push the plunger to evenly administer the antibiotic over a period of 5 minutes.
3. After completion of antibiotic administration and once the syringe is empty, remove the syringe and flush the access as directed by the physician or as recommended for healthcare professionals.
4. Apply a new clean cap to the central access and carefully dispose of the syringe in the sharps container.