Meropenem Star Pharmasin 500 mg powder for solution for injection/infusion – patient leaflet, side effects, dosage

1. What Meropenem Star Pharmasin is and what it is used for

• Keep this leaflet. You may need to read it again.
• Infection affecting the lungs (pneumonia)
• Lung and bronchial infections in patients suffering from cystic fibrosis
• If you have any further questions, ask your doctor, pharmacist or nurse.
• Possible side effects

Meropenem Star Pharmasin contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• How to use Meropenem Star Pharmasin
• Complicated infections in the abdomen

• Infections that you can catch during or after the delivery

  Meropenem Star Pharmasin may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above. Meropenem Star Pharmasin may be used in the management of neutropenic patients (patients with low levels of white blood cells called neutrophils) with fever that is suspected to be due to a bacterial infection.

2. What you need to know before you use Meropenem Star Pharmasin

• Complicated skin and soft tissues infections
• you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meropenem Star Pharmasin (listed in Section 6 Contents of the pack and other information).
• Acute bacterial infection of the brain (meningitis)

Warnings and precautions

• you have health problems, such as liver or kidney problems.
• you have had severe diarrhoea after taking other antibiotics.

You may develop signs and symptoms of severe skin reactions (see section 4). If this happens talk to your doctor or nurse immediately so that they can treat the symptoms.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before using Meropenem.

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Meropenem can affect the way some medicines work and some medicines can have an effect on Meropenem.

• you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem.

In particular, tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you.

• Valproic acid/sodium valproate/valpromide (used to treat epilepsy). Meropenem should not be used because it may decrease the effect of sodium valproate.
• Oral anti-coagulant agent (used to treat or prevent blood clots). Do not use Meropenem Star Pharmasin if:
• Probenecid (used to treat gout).

Talk to your doctor, pharmacist or nurse before using Meropenem Star Pharmasin if:

Other medicines and Meropenem Star Pharmasin

Driving and using machines

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. It is preferable to avoid the use of Meropenem Star Pharmasin during pregnancy.

Your doctor will decide whether you should use Meropenem.

It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving Meropenem Star Pharmasin. Small amounts of this medicine may pass into the breast milk. Therefore, your doctor will decide whether you should use Meropenem while breast-feeding.

• The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose every 8 hours. However you may receive a dose less often if your kidneys do not work very well.

Meropenem has been associated with headache and tingling or pricking skin (paraesthesia). Any of these side effects could affect your ability to drive or operate machines.

Meropenem may cause involuntary muscle movements which may cause the person's body to shake rapidly and uncontrollably (convulsions). This is usually accompanied with a loss of consciousness. Do not drive or use machines if you experience this side effect.

Meropenem Star Pharmasin contains sodium

Meropenem Star Pharmasin 1 g: This medicine contains 90.2 mg sodium (main component of cooking/table salt) in each 1 g dose. This is equivalent to 4.5% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Meropenem Star Pharmasin

Use in adults

No studies on the effect on the ability to drive and use machines have been performed.

If you have a condition which requires you to monitor your sodium intake please inform your doctor, pharmacist or nurse.

Meropenem Star Pharmasin 500 mg: This medicine contains 45.1 mg sodium (main component of cooking/table salt) in each 500 mg dose. This is equivalent to 2.25% of the recommended maximum daily dietary intake of sodium for an adult.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

• The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need.

Use in children and adolescents

Meropenem Star Pharmasin 500 mg powder for solution for injection/infusion

Meropenem Star Pharmasin 1 g powder for solution for injection/infusion

meropenem

• The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meropenem for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose.
• You should normally have your injections at the same times each day. How to use Meropenem Star Pharmasin
• Meropenem will be given to you as an injection or infusion into a large vein.
• You doctor or nurse will normally give Meropenem to you.

If you use more Meropenem Star Pharmasin than you should

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you stop using Meropenem Star Pharmasin

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

• However, some patients, parents and carers are trained to give Meropenem at home. Instructions for doing this are provided in this leaflet (in the section called ‘Instructions for giving Meropenem to yourself or someone else at home’). Always use Meropenem exactly as your doctor has told you. You should check with your doctor if you are not sure.

If you forget to use Meropenem Star Pharmasin

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions

If you have a severe allergic reaction, stop using Meropenem and see a doctor straight away. You may need urgent medical treatment. The signs may include a sudden onset of:

• Your injection should not be mixed with or added to solutions that contain other medicines.

Do not stop having Meropenem until your doctor tells you to.

• Severe rash, itching or hives on the skin.
• Shortness of breath, wheezing or trouble breathing.
• The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem.

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not have a double dose (two injections at the same time) to make up for a forgotten dose.

• Swelling of the face, lips, tongue or other parts of the body.
• Serious skin reactions which include

How to prepare this medicine

• The medicine must be mixed with another liquid (the diluent). Your doctor will tell you how much of the diluent to use.
• Use the medicine straight after preparing it. Do not freeze it. Warning – You should only give this medicine to yourself or someone else at home after a doctor or nurse has trained you.

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

Instructions for giving Meropenem to yourself or someone else at home

Some patients, parents and carers are trained to give Meropenem at home.

1. 1. Wash your hands and dry them very well. Prepare a clean working area.
2. 3. Remove the coloured cap and clean the grey rubber stopper with an alcohol wipe. Allow the rubber stopper to dry.
3. 5. Draw up the recommended amount of sterile ‘Water for Injections’ into the syringe. The amount of liquid that you need is shown below:
4. 4. Connect a new sterile needle to a new sterile syringe, without touching the ends.
5. 2.

   Remove the Meropenem bottle (vial) from the packaging. Check the vial and the expiry date. Check that the vial is intact and has not been damaged.

   1. 10.

      Remove the needle and syringe from the vial and throw the empty vial away

      in a safe place.

   2. 6.

      Put 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.

Please note: If your prescribed dose of Meropenem is more than 1 g, you will need to use more than 1 vial of Meropenem. You can then draw the liquid in the vials into the one syringe.

1. 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 more with a new alcohol wipe and allow the rubber stopper to dry.

2. 8.

   With the plunger of the syringe pushed fully into the syringe, put the needle

   back through the grey rubber stopper. You must then hold both the syringe and the vial and turn the vial upside down.

3. 9.

   Keeping the end of the needle in the liquid, pull back the plunger and draw

   all the liquid in the vial into the syringe.

4. 11.

   Hold the syringe upright, with the needle pointing upwards. Tap the syringe

   so that any bubbles in the liquid rise to the top of the syringe.

5. 12.

   Remove any air in the syringe by gently pushing the plunger until all the air

   has gone.

6. 13.

   If you are using Meropenem at home, dispose of any needles and infusion

   lines that you have used in an appropriate way. If your doctor decides to stop your treatment, dispose of any unused Meropenem in an appropriate way.

Giving Meropenem Injection:

You can either give this medicine through a short cannula or venflon, or through

1. 2. Wipe the end of the short cannula or venflon with an alcohol wipe and allow it to dry. Open the cap on your cannula and connect the syringe.
2. 5. Close the cap of your cannula and carefully throw the syringe away in your sharps bin.

a port or central line.

Giving Meropenem through a short cannula or venflon

1. 1. Remove the needle from the syringe and throw the needle away carefully in your sharps bin.
2. 3. Slowly push the plunger of the syringe to give the antibiotic steadily over about 5 minutes.
3. 4. Once you have finished giving the antibiotic and the syringe is empty, remove the syringe and use a flush as recommended by your doctor or nurse.

Giving Meropenem through a port or central line

1. 1. Remove the cap on the port or line, clean the end of the line with an alcohol

wipe and allow it to dry.

1. 2. Connect the syringe and slowly push the plunger on the syringe to give the antibiotic steadily over about 5 minutes.
2. 3. Once you have finished giving the antibiotic, remove the syringe and use a flush as recommended by your doctor or nurse.
3. 4. Place a new clean cap on your central line and carefully throw the syringe away in your sharps bin.

The following information is intended for healthcare professional only. For full prescribing information please refer to the SmPC. Meropenem is usually given by intravenous infusion over approximately 15 to

30 minutes (see sections 6.2, 6.3 and 6.6).

Posology and method of administration

Posology

The dose of meropenem administered and the duration of treatment should take into account the type of infection to be treated, including its severity, and the clinical response.

The tables below provide general recommendations for dosing.

Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below).

A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp.) or very severe infections.

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• Inflammation of the bowel with diarrhoea.
• Infections of the mouth or the vagina that are caused by a fungus (thrush).
• Severe skin rashes that can appear as reddish circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) or a more severe form (toxic epidermal necrolysis).
• A tingling feeling (pins and needles).
• Red or brown urine.

Other possible side effects:

• Skin rash, itchy skin.
• Serious hypersensitivity reactions involving fever, skin rash, and changes in the blood tests that check how the liver is working (increased levels of liver enzymes) and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs of a multi-organ sensitivity disorder known as DRESS syndrome.
• Feeling sick (nausea).
• Pain and inflammation.
• Increased numbers of platelets in your blood (shown in a blood test).
• Changes in blood tests, including tests that show how well your liver is working.

Uncommon (may affect up to 1 in 100 people)

Damage to red blood cells (not known)

• Changes in your blood. These include reduced numbers of platelets (which may make you bruise more easily), increased numbers of some white blood cells, decreased numbers of other white cells and increased amounts of a substance called ‘bilirubin’. Your doctor may do blood tests from time to time.
• Changes in blood tests, including tests that show how well your kidneys are working.
• Severe red scaly rash, skin bumps that contain pus, blisters or peeling of skin, which may be associated with a high fever and joint pains.
• Abdominal (stomach) pain.

Common (may affect up to 1 in 10 people)

• Being sick (vomiting).

If you notice any of the above, see a doctor straight away.

The signs include:

• Headache.
• Diarrhoea.
• Being breathless when you do not expect it.

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The medicinal product does not require any special storage conditions.

5. How to store Meropenem Star Pharmasin

Keep this medicine out of the sight and reach of children.

If not used immediately in-use storage times and conditions are the responsibility of the user.

• 3 hours when stored at up to 25°C when Meropenem is dissolved in sodium chloride;
• when Meropenem is dissolved in dextrose the solution should be used immediately.
• Fits (convulsions).
• Acute disorientation and confusion (delirium).

Infusion

Reporting of side effects

• 12 hours when stored under refrigerated conditions (2-8°C). Do not use this medicine after the expiry date which is stated on the container. The expiry date refers to the last day of that month.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

After reconstitution: The reconstituted solutions for intravenous injection should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous injection should not exceed:

• 24 hours when stored under refrigerated conditions (2-8°C) when Meropenem is dissolved in sodium chloride;

From a microbiological point of view, unless the method of opening / reconstitution / dilution precludes the risk of microbiological contamination, the product should be used immediately.

• 3 hours when stored at up to 25°C;

Injection

After reconstitution: The reconstituted solutions for intravenous infusion should be used immediately. The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed:

• Sore veins where Meropenem is injected.
• Other changes in your blood. The symptoms include frequent infections, high temperature and sore throat. Your doctor may do blood tests from time to time.

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

Meropenem Wogen Pharm 1 g pulveris injekciju/infūziju šķīduma pagatavošanai Latvia: Meropenem Wogen Pharm 500 mg pulveris injekciju/ infūziju šķīduma pagatavošanai

Estonia: Meropenem Wogen Pharm

Do not freeze the reconstituted solution.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Star Pharmasin Ltd.

Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem

6. Contents of the Pack and Other Information

What Meropenem Star Pharmasin contains

Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem

The other ingredient is anhydrous sodium carbonate.

What Meropenem Star Pharmasin looks like and contents of the pack

Meropenem is a white to slight yellow crystalline powder for solution for injection / infusion in a vial. Pack sizes of 10 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

2411 Nicosia,

Cyprus

Venus Pharma GmbH,

Am-Bahnhof 1-3,

59368, Weme,

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland: Meropenem Star Pharmasin 500 mg and 1 g powder for solution for injection/infusion

9 Theodosi Pierides Str,

Italy: Meropenem Star Pharmasin 500 mg and 1 g powder for solution for injection/infusion

Portugal: Meropenem Star Pharmasin

Manufacturer

United Kingdom: Meropenem Star Pharmasin 500 mg and 1 g powder for solution for injection/infusion

Lithuania: Meropenem Wogen Pharm 500 mg milteliai injekciniam/infuziniam tirpalui

Meropenem Wogen Pharm 1 g milteliai injekciniam/infuziniam tirpalui

This leaflet was last revised in 11/2020

1. 4. You should not give antibiotics that were prescribed for you to other people. Advice/medical education

When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working. Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

1. 1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them. Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.
2. 3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
3. 2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
4. 5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.

meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.

Hepatic impairment: No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).

Alternatively, doses up to 1 g can be given as an intravenous bolus injection over approximately 5 minutes. There are limited safety data available to support the administration of 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 shown below. There are limited data to support the administration of these dose adjustments for a unit dose of 2 g.

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 dose regimen has not been identified. However, limited pharmacokinetic data suggest that 20 mg/kg every 8 hours may be an appropriate regimen (see section 5.2). There are no established dose recommendations for patients receiving peritoneal dialysis.

Dose in elderly patients: No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.

Children over 50 kg body weight

There is no experience in children with renal impairment.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

This medicinal product must not be mixed with other medicinal products except The recommended dose regimens are shown in the table below: Children from 3 months to 11 years of age and up to 50 kg body weight

The adult dose should be administered.

Method of administration: Meropenem is usually given by intravenous infusion over approximately 15 to 30 minutes (see sections 6.2, 6.3, and 6.6). Alternatively, meropenem doses of up to 20 mg/kg may be given as an intravenous bolus over approximately 5 minutes. There are limited safety data available to support the administration of a 40 mg/kg dose in children as an intravenous bolus injection.

Incompatibilities

those mentioned in section 6.6.

2 years

Shelf Life

Intravenous bolus injection administration: A solution for bolus injection is prepared by dissolving the drug product in water for injection to a final concentration of 50 mg/ml. Chemical and physical in-use stability for a prepared solution for bolus injection has been demonstrated for 3 hours at up to 25°C or 12 hours under refrigerated conditions (2-8°C).

If not used immediately in-use storage times and conditions are the responsibility of the user.

Intravenous infusion administration: A solution for infusion is prepared by dissolving the drug product in either 0.9% sodium chloride solution for infusion or 5% dextrose solution for infusion to a final concentration of 1 to 20 mg/ml. Chemical and physical in-use stability for a prepared solution for infusion using 0.9% sodium chloride solution has been demonstrated for 3 hours at up to 25°C or 24 hours under refrigerated conditions (2-8°C).

From a microbiological point of view, unless the method of opening / reconstitution / dilution precludes the risk of microbiological contamination, the product should be used immediately.

After reconstitution

From a microbiological point of view, unless the method of opening / reconstitution / dilution precludes the risk of microbiological contamination, the product should be used immediately.

If not used immediately in-use storage times and conditions are the responsibility of the user.

Reconstituted solution of meropenem in 5% glucose (dextrose) solution should be used immediately.

The constituted solutions should not be frozen.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Do not freeze the reconstituted solution.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

Special precautions for disposal and other handling

Injection: Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection.

Infusion: For intravenous infusion meropenem vials may be directly constituted with 0.9% sodium chloride or 5% dextrose solutions for infusion.

Each vial is for single use only.

Standard aseptic techniques should be used for solution preparation and administration.

The solution should be shaken before use.

Any unused product or waste material should be disposed of in accordance with local requirements.

Size : 450 x 380 mm