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Zedbac 500mg powder for solution for infusion
Zedbac 500mg powder for solution for infusion
Azithromycin (as dihydrate)
1. What Zedbac is and what it is used for
2. What you need to know before you are given Zedbac
3. How to use Zedbac
4. Possible side effects
5. How to store Zedbac
6. Contents of the pack and other information
Zedbac belongs to a group of antibiotics called macrolides. It is used to treat localised infections caused by bacteria in many different parts of the body.
Zedbac is indicated for treatment of serious infections or when oral treatment cannot be used. It is used for treatment of pneumonia (lung infection), and pelvic infections (infection of the reproductive organs) caused by susceptible organisms.
Talk to your doctor, pharmacist or nurse before using Zedbac
Other important precautions:
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Medicines can interact with each other or with other substances causing unexpected drug reactions or in some cases may cause a decrease or increase of the expected effect. Therefore, you should inform your doctor about all the medicines you are taking or have taken, in particular:
You should not take Zedbac with antacids (used for indigestion).
Please contact your doctor or pharmacist before taking any medicine.
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.
Side effects could occur which may influence your ability to drive or use machines (see section 4). You are advised not to drive or use machines whilst taking Zedbac.
This medicine contains 114mg (4.96mmol) sodium (main component of cooking/table salt) in each 500mg vial. This is equivalent to 5.7% of the recommended maximum daily dietary intake of sodium for an adult.
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the dose and treatment duration which are suitable for you.
The following information describes the doses most commonly used in adults for the treatment of pneumonia (lung infection) and pelvic infections.
500mg administered as a single intravenous daily dose for at least two days, followed by oral administration of azithromycin. The appropriate timing of the switch to oral therapy should be done at the discretion of your doctor.
500mg administered as a single intravenous daily dose for one or two days, followed by oral administration of azithromycin. The appropriate timing of the switch to oral therapy should be done at the discretion of your doctor.
Zedbac is intended to be administered by intravenous infusion.
This medicine should be reconstituted and diluted according to the instructions, and should be administered as an intravenous infusion over at least 60 minutes.
The duration of your treatment will depend on the severity of your infection. Your doctor will inform you about it.
Zedbac is not recommended for use in children and growing adolescents.
Patients with kidney or liver problems:
No dose adjustment is needed for elderly patients.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical attention immediately.
Other side effects that may occur when taking Zedbac are listed below. These may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you.
Very common (may affect more than 1 in 10 people) side effects are:
Common (may affect up to 1 in 10 people) side effects are:
Uncommon (may affect up to 1 in 100 people) side effects are:
Rare (may affect up to 1 in 1,000 people) side effects are:
Not known (frequency cannot be estimated from the available data) side effects are:
Local injection site reactions (inflammation/pain) have been reported with the intravenous administration of azithromycin.
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 the Google Play or Apple App store). By reporting side effects you can help provide more information on the safety of this medicine.
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 and the vial after EXP. The expiry date refers to the last day of that month.
Concentrated solution after reconstitution (according to the instructions): azithromycin as powder for solution for infusion is chemically and physically stable during 24 hours, when stored below 25°C.
Diluted solutions, prepared according to the instructions, are chemically and physically stable for 24 hours at or below 25°C, or for 72 hours if stored at 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Do not use this medicine if you notice that the visual appearance has changed (e.g. the solution is not free from visible particles).
Any unused medicine must be discarded.
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 protect the environment.
Zedbac is a free white powder, for solution for infusion. It comes in a 12ml glass single dose vial, colourless with rubber stopper and sealed with aluminium/plastic flip-off cap.
The appearance of the product after reconstitution is a colourless and clear solution and leaves no visible undissolved matter.
Zedbac is available in the following pack sizes:
Pack with 1 vial.
Marketing Authorisation Holder
This leaflet was last revised in 12/2021