Patient leaflet - MEROPENEM STAR PHARMASIN 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
Size : 450 x 380 mm
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Meropenem Star Pharmasin 500 mg
powder for solution for injection/infusion
Meropenem Star Pharmasin 1 g
powder for solution for injection/infusion meropenem
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor, pharmacist or nurse.
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– 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.
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– If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
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1. What Meropenem Star Pharmasin is and what it is used for
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2. What you need to know before you use Meropenem Star Pharmasin
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3. How to use Meropenem Star Pharmasin
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4. Possible side effects
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5. How to store Meropenem Star Pharmasin
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6. Contents of the pack and other information
1. what meropenem star pharmasin is and what it is used for
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.
Meropenem Star Pharmasin is used to treat the following in adults and children aged 3 months and older:
- Infection affecting the lungs (pneumonia)
- Lung and bronchial infections in patients suffering from cystic fibrosis
- Complicated urinary tract infections
- Complicated infections in the abdomen
- Infections that you can catch during or after the delivery
- Complicated skin and soft tissues infections
- Acute bacterial infection of the brain (meningitis)
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.
Meropenem Star Pharmasin may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above.
2. what you need to know before you use meropenem star pharmasin
Do not use Meropenem Star Pharmasin if:
- 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).
- you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Meropenem Star Pharmasin if:
- you have health problems, such as liver or kidney problems.
- you have had severe diarrhoea after taking other antibiotics.
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.
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.
Other medicines and Meropenem Star Pharmasin
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.
In particular, tell 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 should not be used because it may decrease the effect of sodium valproate.
- Oral anti-coagulant agent (used to treat or prevent blood clots).
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.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
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 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.
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.
If you have a condition which requires you to monitor your sodium intake please inform your doctor, pharmacist or nurse.
3. how to use meropenem star pharmasin
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.
Use in adults
- 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.
- 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.
- 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.
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.
- 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.
- Your injection should not be mixed with or added to solutions that contain other medicines.
- The injection may take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem.
- You should normally have your injections at the same times each day.
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 forget to use Meropenem Star Pharmasin
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.
If you stop using Meropenem Star Pharmasin
Do not stop having Meropenem until your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. possible side effects
Size : 450 x 380 mm
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– 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.
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– 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.
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– 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).
Damage to red blood cells (not known)
The signs include:
- Being breathless when you do not expect it.
- Red or brown urine.
If you notice any of the above, see a doctor straight away.
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Abdominal (stomach) pain.
- Feeling sick (nausea).
- Being sick (vomiting).
- Diarrhoea.
- Headache.
- Skin rash, itchy skin.
- 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.
- 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.
- A tingling feeling (pins and needles).
- Infections of the mouth or the vagina that are caused by a fungus (thrush).
- Inflammation of the bowel with diarrhoea.
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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.
enal 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.
| Creatinine clearance (ml/min) | Dose (based on “unit” dose range of 500 mg or 1 g or 2 g, see table above) | Frequency |
| 26 – 50 | one unit dose | every 12 hours |
| 10 – 25 | half of one unit dose | every 12 hours |
| < 10 | half of one unit dose | every 24 hours |
meropenem is cleared by haemodialysis and haemofiltration. The required dose should be administered after completion of the haemodialysis cycle.
There are no established dose recommendations for patients receiving peritoneal dialysis.
Hepatic impairment: No dose adjustment is necessary in patients with hepatic impairment (see section 4.4).
Dose in elderly patients: No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 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 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).
- 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.
- Fits (convulsions).
- Acute disorientation and confusion (delirium).
Reporting of side effects
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: 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.
5. how to store meropenem star pharmasin
Keep this medicine out of the sight and reach of children.
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.
The medicinal product does not require any special storage conditions.
Injection
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:
- 3 hours when stored at up to 25°C;
- 12 hours when stored under refrigerated conditions (2–8°C).
Infusion
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:
- 3 hours when stored at up to 25°C when Meropenem is dissolved in sodium chloride;
- 24 hours when stored under refrigerated conditions (2–8°C) when Meropenem is dissolved in sodium chloride;
- when Meropenem is dissolved in dextrose the solution should be used immediately.
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.
Children from 3 months to 11 years of age and up to 50 kg body weight
The recommended dose regimens are shown in the table below:
| Infection | Dose to be administered every 8 hours |
| Severe pneumonia including hospital and ventilator-associated pneumonia. | 10 or 20 mg/kg |
| Broncho-pulmonary infections in cystic fibrosis | 40 mg/kg |
| Complicated urinary tract infections | 10 or 20 mg/kg |
| Complicated intra-abdominal infections | 10 or 20 mg/kg |
| Intra and post-partum infections | 10 or 20 mg/kg |
| Complicated skin and soft tissue infections | 10 or 20 mg/kg |
| Acute bacterial meningitis | 40 mg/kg |
| Management of febrile neutropenic patients | 20 mg/kg |
Children over 50 kg body weight
The adult dose should be administered.
There is no experience in children with renal impairment.
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.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except
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.
6. contents of the pack and other information
What Meropenem Star Pharmasin contains
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem
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
Star Pharmasin Ltd.
9 Theodosi Pierides Str,
2411 Nicosia,
Cyprus
Manufacturer
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
Italy: Meropenem Star Pharmasin 500 mg and 1 g powder for solution for injection/infusion
Portugal: Meropenem Star Pharmasin
United Kingdom: Meropenem Star Pharmasin 500 mg and 1 g powder for solution for injection/infusion
Estonia: Meropenem Wogen Pharm
Latvia: Meropenem Wogen Pharm 500 mg pulveris injekciju/ infuziju skiduma pagatavosanai
Meropenem Wogen Pharm 1 g pulveris injekciju/infuziju skiduma pagatavosanai those mentioned in section 6.6.
Shelf Life
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2 years
After reconstitution
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).
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.
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.
If not used immediately in-use storage times and conditions are the responsibility of the user.
Lithuania: Meropenem Wogen Pharm 500 mg milteliai injekciniam/infuziniam tirpalui
Meropenem Wogen Pharm 1 g milteliai injekciniam/infuziniam tirpalui
Advice/medical education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
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.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.
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.
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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.
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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.
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3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
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4. You should not give antibiotics that were prescribed for you to other people.
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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.