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Sivextro 200 mg powder for concentrate for solution for infusion
Sivextro® 200 mg powder for concentrate for solution for infusion
1. What Sivextro is and what it is used for
2. What you need to know before you are given Sivextro
3. How you will be given Sivextro
4. Possible side effects
5. How to store Sivextro
6. Contents of the pack and other information
Sivextro is an antibiotic that contains the active substance tedizolid phosphate. It belongs to a group of medicines called “oxazolidinones.”
It is used to treat adults and adolescents 12 years of age and older with infections of the skin and tissues below the skin.
It works by stopping the growth of certain bacteria which can cause serious infections.
Your doctor will have decided if Sivextro is suitable to treat your infection.
Talk to your doctor or nurse before being given Sivextro if any of the following apply to you:
Ask your doctor or pharmacist if you are not sure whether you are taking any of these medicines.
Contact your doctor straight away if you suffer from diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Resistance to antibiotics
Bacteria can become resistant to treatment with antibiotics over time. This is when antibiotics cannot stop the growth of bacteria and treat your infection. Your doctor will decide if you should be given Sivextro to treat your infection.
Possible side effects
Certain side effects have been observed with Sivextro or another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro. Tell your doctor straight away if you suffer from any of the following while taking Sivextro:
This medicine should not be used in children under 12 years of age as it has not been studied enough in this population.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are also taking:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.
It is not known if Sivextro passes into breast milk in humans. Ask your doctor for advice before breast-feeding your baby.
Do not drive or use machines if you feel dizzy or tired after taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
Sivextro will be given to you by a nurse or doctor.
It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
You will be given one 200 mg infusion of Sivextro once a day for 6 days.
Talk to a doctor if you do not feel better, or if you feel worse after 6 days.
Tell your doctor or nurse immediately if you are concerned that you may have been given too much Sivextro.
Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor straight away if you suffer from diarrhoea during or after your treatment.
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Frequency not known (frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor 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 vial label after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any particles or the solution is cloudy.
Once opened this medicine must be used immediately. If not, the reconstituted and diluted solution should be stored at room temperature or in a refrigerator at 2°C to 8°C, and administered within 24 hours after reconstitution.
Any unused medicine or waste material, including materials used for reconstitution, dilution and administration, should be disposed of in accordance with local requirements.
Sivextro is a white to off-white powder for concentrate for solution for infusion in a glass vial. The powder will be reconstituted in the vial with 4 mL of water for injections. The reconstituted solution will be withdrawn from the vial and added to an infusion bag of 0.9% sodium chloride in the hospital.
It is available in packs containing 1 or 6 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
For any information about this medicine, please contact:
This leaflet was last revised in June 2022.
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.