500 mg powder for solution for injection or infusion,
meropenem solution
What Meropenem SUN is and what it is used for
Meropenem SUN belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria that can cause serious infections.
- Infection is in the lungs ( pneumonia )
- Infection in the lungs and bronchus in patients with cystic fibrosis
- Complicated urinary tract infections
- Complicated abdominal infections
- Infection you that can occur during or after childbirth
- Complicated infection is in the skin or soft tissues
- Acute bacterial infections in the brain ( meningitis )
Meropenem SUN can be used to treat neutropenic patients with a fever suspected of being a bacterial infection.
Meropenem SUN can be used to treat bacterial infections in the blood that may be associated with any of the infections mentioned above.
Meropenem contained in Meropenem SUN may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Meropenem SUN
Do not use Meropenem SUN
- If you are allergic to meropenem or any of the other ingredients of this medicine (see section 6)
- If you are allergic (hypersensitive) to other antibiotics , such as penicillins , cephalosporins or carbapenems, you may also be allergic to meropenem
Warnings and cautions
Talk to your doctor or pharmacist before receiving Meropenem SUN:
- If you have health problems, such as liver or kidney disease.
- If you get severe diarrhea after taking other antibiotics .
You can get a positive result on a blood test (Coombs test) which indicates the presence of antibodies that can destroy your red blood cells. Your doctor will talk to you about this.
If you are not sure if any of the above applies to you, talk to your doctor or nurse before receiving Meropenem SUN.
Other medicines and Meropenem SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Meropenem SUN can affect the way some medicines work and some medicines can affect Meropenem.
In particular, tell your doctor or pharmacist if you are taking the following medicines:
- Probenecid (medicine for gout )
- Valporic acid / sodium valproate / valpromide (antiepileptic medicine ) . Menoperem SUN should not be used because it may impair the effect of sodium valporate.
- Blood thinners taken by mouth (used to treat or prevent blood clots).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is desirable to avoid Meropnemen SUN during pregnancy.
Your doctor will decide if you should receive Meropenem SUN.
You must tell your doctor if you are breastfeeding or planning to start breastfeeding before receiving Meropenem SUN. Small amounts of this medicine may pass into breast milk. Therefore, your doctor will decide if you should be given Meropenem SUN while you are breastfeeding.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Meropenem Sun has been associated with headaches and tingling and tingling in the skin ( paresthesia ) and involuntary muscle movements, which can cause rapid and uncontrollable tremors (cramps). These are often accompanied by loss of consciousness. All of these side effects can affect your ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Meropenem SUN contains sodium
Meropenem SUN 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-salt diet.
Meropenem SUN 1 g: This medicine contains approximately 4.0 mEq of sodium per 1 g dose, which should be taken into consideration by patients on a low-salt diet.
If you have a health problem that requires you to control your sodium intake, tell your doctor or nurse.
How to use Meropenem SUN
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Adults
- Dose one depends on the type of infection you have, where in the body infection one is sitting and how serious it is. Your doctor will determine the dose you need.
- One dose for adults is usually between 500 mg (milligrams) and 2 g (grams). You are usually given one dose every 8 hours. But you get a dose less often if your kidneys do not work really well.
Use for children and adolescents
- Dose one for children over 3 months and up to 12 years depends on the child’s age and weight. The usual dose is between 10 mg and 40 mg of Meropenem SUN for each kilogram (kg) that the child weighs. One dose is usually given every 8 hours. Children weighing over 50 kg will receive an adult dose.
Method of administration
- Meropenem SUN will be given to you as an injection or infusion into a large vein
- Your doctor or nurse will normally give you Meropenem SUN
- Some patients, parents or caregivers are sometimes trained to give Meropenem SUN at home. Instructions for doing this can be found in this leaflet (in the section “Instructions for giving Meropenem SUN to yourself or someone else at home”). Always use Meropenem SUN exactly as your doctor has told you. If you are not sure, talk to your doctor.
- Your injection should not be mixed with or added to solutions containing other medicines
- Injection one can take about 5 minutes or between 15 and 30 minutes. Your doctor will tell you how to give Meropenem SUN
- You should normally get your injections at the same time each day
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions
If you get a severe allergic reaction, stop using Meropenem SUN and contact a doctor immediately. You may need urgent medical attention. The symptoms and signs may appear suddenly:
- Severe rash, itching or hives on the skin
- Swelling of the face, lips, tongue or other parts of the body
- Shortness of breath, wheezing or difficulty breathing
Damage to red blood cells (no known frequency – the frequency can not be estimated from the available data)
Symptoms that may occur:
- Shortness of breath when you do not expect it
- Red or brown urine
If you notice any of the above symptoms, contact a doctor immediately.
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Magont
- Nausea
- Vomiting
- Diarrhea
- Headache
- Skin rash, itching
- Pain and inflammation
- Increased platelet count in the blood (measured 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)
- Changes in the blood. These include decreased platelet count (which makes it easier for you to get bruises), increased number of certain white blood cells , decreased number of other white blood cells and increased amounts of a substance called ‘bilirubin’. Your doctor may take blood samples from time to time
- Changes in values from blood tests, including tests that show how well your kidneys are working
- Tingling and tingling
- Infection is in the mouth or vagina caused by a fungus (candidiasis).
- Inflammation of the intestine with diarrhea
- Tenderness in the vein where Meropenem SUN is injected.
- Other changes in the blood. Symptoms may include frequent infections , high fever and sore throat. Your doctor may take blood samples from time to time.
- Sudden onset of severe rash, blisters or flaky skin. This can be associated with high fever and joint pain
Rare (may affect up to 1 in 1,000 people)
- Seizures (convulsions).
Frequency not known (can not be estimated from the available data)
- Severe hypersensitivity reaction with fever, rash and changes in blood tests that control how the liver works (increased levels of liver enzymes) and an increase in a type of white blood cell ( eosinophilia ) and enlarged lymph nodes . These can be signs of a multi-organ sensitivity disorder called DRESS syndrome.
How to store Meropenem SUN
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 carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C
After reconstitution: Reconstituted solutions for intravenous injection or infusion should be used immediately. The time between the start of reconstitution and the end of intravenous injection or infusion should not exceed one hour.
The prepared solution must not be frozen
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is meropenem
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 the medicine looks like and contents of the pack
Meropenem SUN is a white or light yellow crystalline powder for solution for injection or infusion in a vial.
There are 1 or 10 vials per pack.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH, Hoofddorp
Netherlands
Manufacturer:
Therapy SA
124 Fabricii Street
400 632 Cluj Napoca
Romania
Or
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH, Hoofddorp
Netherlands