Meropenem Venus Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meropenem Venus Pharma 500 mg powder for injection solution or infusion, 1 g powder for injection solution or infusion

Equivalent medicine

• Read this leaflet carefully before taking this medicine. Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Meropenem Venus Pharma is and what it is used for
2. Before you take Meropenem Venus Pharma
3. How to take Meropenem Venus Pharma
4. Possible side effects
5. How to store Meropenem Venus Pharma
6. Further information

1. What MEROPENEM VENUS PHARMA is and what it is used for

Meropenem Venus Pharma belongs to a group of medicines called carbapenem antibiotics and works by killing bacteria that can cause serious infections.

• Infections affecting the lungs (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 infections of the brain (meningitis)

Meropenem Venus Pharma may be used to treat febrile neutropenic patients when a bacterial infection is suspected.

2. Before taking MEROPENEM VENUS PHARMA

Do not use Meropenem Venus Pharma

• if you are allergic (hypersensitive) to meropenem or to any of the excipients of Meropenem Venus Pharma (listed in section 6, Other Information).
• if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems, because you may also be allergic to meropenem.

Take special care with Meropenem Venus Pharma
Check with your doctor before using Meropenem Venus Pharma:

• if you have any health problems, such as liver or kidney problems
• if you have previously experienced severe diarrhoea after taking other antibiotics.

You may test positive in a test (the Coombs test) indicating the presence of antibodies that can destroy red blood cells. Your doctor will discuss this issue with you.
If you are unsure whether any of these conditions apply to you, speak with your doctor before taking Meropenem Venus Pharma.
Taking Meropenem Venus Pharma with other medicines
Inform your doctor if you are currently taking or have recently taken any other medicines, including those obtained without a prescription and herbal preparations.
This is because Meropenem Venus Pharma may affect how some medicines work, and some medicines may affect Meropenem Venus Pharma.
In particular, inform your doctor if you are taking any of the following medicines:

• Probenecid (used to treat gout)
• Sodium valproate (used to treat epilepsy). Meropenem Venus Pharma must not be used, as it may reduce the effectiveness of sodium valproate.

Pregnancy and breastfeeding
Before taking Meropenem, it is important that you inform your doctor if you are pregnant or plan to become pregnant. It is preferable to avoid the use of Meropenem during pregnancy.
Your doctor will decide whether you should take Meropenem.
Before taking Meropenem, it is important that you inform your doctor if you are breastfeeding or plan to breastfeed. Small amounts of this medicine may pass into breast milk and may affect the baby. Therefore, your doctor will decide whether you should take Meropenem during breastfeeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
No studies have been conducted on the ability to drive vehicles or use machinery.
Important information about some excipients of Meropenem Venus Pharma
Meropenem Venus Pharma contains sodium.
Meropenem Venus Pharma 500 mg: this medicine contains approximately 2.0 mEq of sodium per 500 mg dose, which should be taken into consideration by patients on a low-sodium diet.
Meropenem Venus Pharma 1.0 g: this medicine contains approximately 4.0 mEq of sodium per 1.0 g dose, which should be taken into consideration by patients on a low-sodium diet.
If you suffer from a condition that requires restriction of sodium intake, inform your doctor or nurse.

3. How to use MEROPENEM VENUS PHARMA

Adults

• The dose depends on the type of infection you have, the site of the infection, and the severity of the infection. Your doctor will decide the dose you need.
• The usual dose for adults ranges from 500 mg (milligrams) to 2 g (grams). You will usually receive a dose every 8 hours. However, you may receive the dose less frequently if your kidneys are not functioning properly.

Use in children and adolescents

• The dose for children over 3 months and up to 12 years of age is determined based on the child's age and body weight. The usual dose is between 10 mg and 40 mg of Meropenem Venus Pharma per kilogram (kg) of the child’s body weight. It is usually administered every 8 hours. Children weighing more than 50 kg will receive the adult dose.
• Meropenem Venus Pharma will be administered as an injection or infusion into a large vein.
• Usually, Meropenem Venus Pharma will be administered by a doctor or nurse.
• However, some patients, parents, or caregivers may be trained to administer Meropenem Venus Pharma at home. Instructions for this are provided in this leaflet (in the section “Instructions for self-administration or administration to others at home”). Always use Meropenem Venus Pharma exactly as prescribed by your doctor. Ask your doctor if you are unsure.
• The injection must not be mixed with or added to solutions containing other medicinal products.
• The injection may take about 5 minutes or from 15 to 30 minutes. Your doctor will instruct you on how to administer Meropenem Venus Pharma.
• Injections should normally be given at the same time each day.

If you use more Meropenem Venus Pharma than you should
If you accidentally use more than the prescribed dose, contact your doctor or go immediately to the nearest hospital.
If you forget to use Meropenem Venus Pharma
If a dose has been missed, it should be administered as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped.
Do not administer a double dose (two injections at the same time) to make up for a missed dose.
If you stop using Meropenem Venus Pharma
Do not stop using Meropenem Venus Pharma unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The frequency of the possible side effects listed below is defined using the following convention:
Very common (affects more than 1 in 10 people)
Common (affects 1 to 10 in 100 people)
Uncommon (affects 1 to 10 in 1,000 people)
Rare (affects 1 to 10 in 10,000 people)
Very rare (affects fewer than 1 in 10,000 people)
Not known (cannot be estimated from the available data).

Severe allergic reactions
If a severe allergic reaction occurs, you must stop taking Meropenem Venus Pharma and see a doctor immediately. You may need urgent medical treatment. Symptoms of an allergic reaction may include sudden onset of:

• severe rash, itching or hives
• swelling of the face, lips, tongue or other parts of the body
• difficulty breathing, wheezing or breathing problems.

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

• becoming breathless when you did not expect to
• red or brown urine

If you notice any of these symptoms, you must see a doctor immediately.

Other possible side effects

Common

• Abdominal (stomach) pain
• Nausea (feeling unwell)
• Vomiting (being sick)
• Diarrhoea
• Headache
• Skin rash, skin itching
• Pain and inflammation
• Increased number of platelets in the blood (shown by a blood test)
• Changes in laboratory tests, including tests showing liver function.

Uncommon

• Blood disorders. These include: reduced number of platelets (which may lead to bruising more easily), increased levels of certain types of white blood cells, decreased levels of other white blood cells, and increased levels of a substance called bilirubin. Your doctor may occasionally prescribe blood tests.
• Changes in blood tests, including those showing kidney function.
• Tingling sensation.
• Mouth or vaginal fungal infections (thrush).

Rare

• Seizures.

Other possible side effects of unknown frequency

• Inflammation of the bowel with diarrhoea.
• Pain in the vein where Meropenem Venus Pharma was injected.
• Other blood disorders. Symptoms include frequent infections, fever and sore throat. Your doctor may occasionally prescribe blood tests.
• Sudden onset of severe rash, blisters or skin peeling. These reactions may be accompanied by high fever and joint pain.

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

5. How to store MEROPENEM VENUS PHARMA

Keep this medicine out of the reach and sight of children.
Do not use Meropenem Venus Pharma after the expiry date stated on the vial label or outer carton after Exp.. The expiry date refers to the last day of that month.
Do not store above 30°C.
After reconstitution: reconstituted solutions for intravenous injection or infusion must be used immediately. The time interval between the start of reconstitution and the end of intravenous injection or infusion must not exceed one hour.
Do not freeze the reconstituted solution. Each reconstituted solution is for single use only.
The reconstituted solution should be clear to slightly yellow and transparent, and must be free from visible particles.
Medicines must 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. Other information

What Meropenem Venus Pharma contains
Meropenem Venus Pharma 500 mg/vial powder for injectable or infusion solution
The active substance is meropenem. Each vial contains 500 mg of meropenem (as trihydrate).
The excipient is anhydrous sodium carbonate.

Meropenem Venus Pharma 1 g/vial powder for injectable or infusion solution
The active substance is meropenem. Each vial contains 1000 mg of meropenem (as trihydrate).
The excipient is anhydrous sodium carbonate.

Description of the appearance of Meropenem Venus Pharma and contents of the pack
Meropenem Venus Pharma is a white to pale yellow powder for injectable or infusion solution in vials.
Pack: 10 vials in a box.

Marketing Authorization Holder
VENUS PHARMA GmbH
AM Bahnhof 1-3, D-59368 Werne, Germany

Responsible manufacturer for batch release
VENUS PHARMA GmbH
AM Bahnhof 1-3, D-59368 Werne, Germany

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS:
Instructions for self-administration or administration to others of Meropenem Venus Pharma at home
Some patients, parents, or caregivers are trained to administer Meropenem Venus Pharma at home.

Warning – You must administer this medicine to yourself or to others at home only after having been trained by a physician or nurse.

• The medicine must be mixed with another liquid (diluent). Your doctor will tell you how much diluent to use.
• Use the medicine immediately after preparation. Do not freeze it.

How to prepare this medicine

1. Wash your hands and dry them thoroughly. Prepare a clean work area.
2. Remove the vial of Meropenem Venus Pharma from its packaging. Check the vial and the expiry date printed on the box and on the vial label. Ensure that the vial is intact and has not been damaged.
3. Remove the colored cap and clean the grey rubber stopper with an alcohol-soaked swab. Allow the rubber stopper to dry.
4. Insert a new sterile needle into a new sterile syringe, taking care not to touch the ends.
5. Draw into the syringe the recommended amount of sterile water for injections. The required volume is indicated below:

For Meropenem 500 mg powder for injectable or infusion solution, the vial has a 10 ml capacity and can be reconstituted with 10 ml of water for injections.
For Meropenem 1 g powder for injectable or infusion solution, the vial has a 20 ml capacity and can be reconstituted with 20 ml of water for injections.

Note: If the prescribed dose of Meropenem Venus Pharma exceeds 1 g, you will need to use more than one vial of Meropenem Venus Pharma. You may draw up the liquid from the vials into a single syringe.
Appearance of the reconstituted solution: The reconstituted solution should be clear to slightly yellow and transparent, and free from visible particles.

6. Insert the needle of the syringe into the centre of the grey rubber stopper and inject the recommended amount of water for injections into the vial or vials of Meropenem Venus Pharma.
7. Remove the needle from the vial and shake the vial well for about 5 seconds, or until the powder is completely dissolved. Clean the grey rubber stopper again with a new alcohol-soaked swab and allow the rubber stopper to dry.
8. With the plunger fully depressed into the syringe, insert the needle again through the grey rubber stopper. Hold both the syringe and the vial, then invert the vial.
9. Keeping the tip of the needle in the liquid, pull back the plunger to draw the liquid from the vial into the syringe.
10. Remove the needle and syringe from the vial and dispose of the vial safely.
11. Hold the syringe upright with the needle tip pointing upwards. Tap the syringe gently so that any air bubbles rise to the top of the syringe.
12. Remove air from the syringe by gently pressing the plunger until all air has been expelled.
13. If you are using Meropenem Venus Pharma at home, properly dispose of the used needle and infusion lines. If your doctor decides to discontinue treatment, properly dispose of any unused Meropenem Venus Pharma.

Note:
Intravenous infusion of meropenem can be prepared by reconstituting the vial contents directly with an infusion solution of 0.9% sodium chloride or 5% glucose. Please follow the instructions below:
Add 10 ml of infusion diluent to Meropenem 500 mg, then shake well to reconstitute, and subsequently add this solution to the infusion bag containing the diluent.
Add 20 ml of infusion diluent to Meropenem 1 g, then shake well to reconstitute, and subsequently add this solution to the infusion bag containing the diluent.
When preparing the infusion in the infusion bag, the following concentrations are obtained:

How to administer the injection
The medicine can be administered using a cannula needle or “Venflon”, or via a catheter or a central line.

Administration of Meropenem Venus Pharma using a cannula needle or “Venflon”

1. Remove the needle from the syringe and carefully dispose of it in the sharps container.
2. Clean the tip of the cannula needle or Venflon with an alcohol-impregnated swab and allow it to dry. Open the cannula cap and connect it to the syringe.
3. Slowly push the plunger of the syringe to administer the antibiotic evenly over approximately 5 minutes.
4. After completing the antibiotic administration and once the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
5. Close the opening of the cannula needle and carefully dispose of the syringe in the waste container.

Administration of Meropenem Venus Pharma via partially or totally implanted central venous catheter (Port-type)

1. Remove the cap from the catheter or line, clean the catheter tip with an alcohol-impregnated swab, and allow it to dry.
2. Attach the syringe and slowly push the syringe plunger to administer the antibiotic evenly over approximately 5 minutes.
3. After completing the antibiotic administration and once the syringe is empty, remove the syringe and flush as recommended by your doctor or nurse.
4. Place a new clean cap on the central catheter and carefully dispose of the syringe in the sharps container.