FUCIDIN IV
Active substance: SODIUM FUSIDATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fucidin IV
sodium fusidate
Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet: 1. 2. 3. 4. 5. 6. What Fucidin IV is and what it is used for Before you have Fucidin IV How to use Fucidin IV Possible side effects How to store Fucidin IV Further information
1. WHAT FUCIDIN IV IS AND WHAT IT IS USED FOR
This medicine contains sodium fusidate. It is a type of antibiotic. Fucidin IV works by killing germs (bacteria) that cause infections. Fucidin IV is used to treat infections such as: Infections of the skin and wounds Infections of the blood such as septicaemia Infections of the bone and heart tissue Infections of the lungs such as pneumonia Infections connected with the condition cystic fibrosis.
2. BEFORE YOU HAVE FUCIDIN IV
Do not have Fucidin IV If you are allergic (hypersensitive) to fusidic acid or its salts. If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. Take special care with Fucidin IV Before you have Fucidin IV, tell your doctor: If you are taking statins (medicines to lower blood cholesterol) If you have problems with your liver If you have recently been jaundiced.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
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When you are having Fucidin IV your doctor may take regular blood tests in patients on high doses, with liver or bile problems, taking the medicine for a long time or taking other medicines that affect the liver. If you are concerned that your treatment is not as effective as it should be, tell your doctor. As with any antibiotic treatment, long term or repeated use may increase the risk of developing antibiotic resistance. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. Do not take statins (medicines to lower blood cholesterol) while using this medicine.
You must tell your doctor or pharmacist if you are taking any of the following medicines: Other antibiotics, such as lincomycin and rifampicin. Oral anti-coagulants (medicines to thin your blood). You may be likely to bleed more easily. Your doctor may need to change your dose. Medicines to lower blood cholesterol, such as statins. This may lead to muscle weakness, tenderness or pain. Also see section 4 of this leaflet. Ritonavir or saquinavir, medicines used to treat HIV. Ciclosporin. This medicine is used to reduce the body's immune reactions. Pregnancy and breast-feeding Please ask your doctor or pharmacist for advice before having Fucidin IV: If you are pregnant, or think you are pregnant If you are breast-feeding. Tell your doctor if you become pregnant while having this medicine. Driving and using machines Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines. Important information about some of the ingredients of Fucidin IV Fucidin IV contains: Sodium. Each reconstituted vial contains 73 milligrams (mg) sodium. You should take this into consideration if you are on a controlled sodium diet. Please ask your doctor if you are worried about any of the ingredients in this medicine.
3. HOW TO USE FUCIDIN IV
Fucidin IV will be given to you into your vein by a doctor or nurse. How much Fucidin IV to have Your doctor will prescribe the right dose for you. If you have received more Fucidin IV than you should Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your doctor or nurse straight away. If you have missed a dose of Fucidin IV
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
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Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your doctor or nurse. If you have any further questions about using this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucidin IV can cause side effects, although not everybody gets them. Approximately 3 out of 10 people may experience side effects with Fucidin IV, but many of these are where the medicine is given into the vein. Serious side effects: Rare (affects less than 1 in 1,000 people): allergic reaction. You must get urgent medical help if you have any of the following symptoms: You have difficulty breathing Your face or throat swell Your skin develops a severe rash. Number of people affected not known: You must get urgent medical help if you have any of the following symptoms. You may be experiencing a condition called rhabdomyolysis: You develop muscle weakness You develop muscle pain You develop muscle tenderness. Common (affects less than 1 in 10 people): problems with your liver. You should tell your doctor straight away if you have the following symptoms: Your skin or the whites of your eyes appear yellow. Number of people affected not known: problems with your kidneys. You should tell your doctor straight away if you have the following symptoms: You are not passing water. Number of people affected not known: the level of some cells in your blood may change. You should tell your doctor straight away if you have any of the following symptoms: You develop any unexplained bruising or bleeding You develop persistent or repeated mouth ulcers, sore throats or other infections. Other possible side effects: Common (affect less than 1 in 10 people): Pain or inflammation of the vein where Fucidin IV is given, dizziness, drowsiness. Uncommon (affect less than 1 in 100 people): Headache, rash, itchy rash, itching, loss of appetite, feeling tired, weak or unwell. Number of people affected not known: Pale stools, dark urine, upper right hand side stomach pain. If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE FUCIDIN IV
Keep out of the reach and the sight of children.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
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Do not use Fucidin IV after the expiry date on the carton. The expiry date is the last day of that month.
6. FURTHER INFORMATION
What Fucidin IV contains The active ingredient is sodium fusidate. A vial of powder contains 500 mg of sodium fusidate.
The other ingredients are citric acid, disodium edetate, disodium hydrogen phosphate and water for injections.
You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Fucidin IV looks like and contents of the pack Fucidin IV comes in packs of 2 vials. One vial contains sodium fusidate (powder) and the other vial the solution for the infusion. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Princes Risborough, Bucks., HP27 9RR, UK. Manufacturer: LEO Pharma A/S, DK 2750, Ballerup, Denmark. This leaflet was last revised in June 2012
PLEASE TEAR ALONG THE PERFORATIONS AND RETAIN THIS PORTION BEFORE GIVING THE REMAINING LEAFLET TO THE PATIENT.
FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY
Fucidin IV
Sodium Fusidate Ph.Eur. 500mg (equivalent to 480mg fusidic acid) contained in one vial. (The second vial contains buffer solution). Powder for reconstitution and use as an intravenous infusion. The vial of 10 ml sterile phosphate-citrate buffer solution (pH 7.4 - 7.6) contains disodium hydrogen phosphate, citric acid, disodium edetate and water for injections. (When reconstituted with powder vial contains 3.1 mMol sodium and 1.1 mMol phosphate). Shelf-life and storage conditions: The sodium fusidate dry powder is stable for 3 years when stored at room temperature (below 25C) and protected from light. After the sodium fusidate dry powder is dissolved in the buffer solution provided and added to 500ml of infusion fluid , the shelf-life of this solution is 24 hours. When the buffer solution is transferred to the powder vial, this vial should be regarded as a unit dose. The required amount of solution should be used once only and any unused portion discarded.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
Page 4 of 5
Recommended procedure for reconstitution and administration: To reconstitute, dissolve the contents of one vial containing 500 mg sodium fusidate powder (equivalent to 480 mg of fusidic acid) in the 10 ml buffer provided. For adults weighing more than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid. For children and adults weighing less than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid. Each dose corresponds to 6-7 ml of the resulting solution per kg bodyweight. The diluted fluid should be infused via a central venous line over 2 hours. If a superficial vein is employed a more prolonged period of at least 6 hours is advisable. This product should be administered intravenously into a wide bore vein with a good blood flow. Excessive doses may cause venospasm, thrombophlebitis and haemolysis of erythrocytes. Both oral and intravenous presentations have been given concurrently with other antibiotics, e.g. cloxacillin, flucloxacillin, ampicillin, methicillin and erythromycin. If additional antibacterial therapy is to be employed, it is recommended that for parenteral administration, separate infusion fluids be used. This product should not be infused with amino acid solutions or in whole blood. In vitro compatibility studies of Fucidin IV with commonly used infusion solutions have been carried out. The results showed that sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically and chemically compatible for at least 24 hours at room temperature with the following infusion solutions (the figure in parenthesis shows the concentration of sodium fusidate in the final admixture): Sodium Chloride Intravenous Infusion BP 0.9% (1-2 mg/ml) Dextrose Intravenous Infusion BP 5% (1-2 mg/ml) Compound Sodium Lactate Intravenous Infusion (Ringer-Lactate Solution) (1 mg/ml) Sodium Lactate Intravenous Infusion BP (1 mg/ml) Sodium Chloride (0.18%) and Dextrose (4%) Intravenous Infusion BP (1 mg/ml) Potassium Chloride (0.3%) and Dextrose (5%) Intravenous Infusion BP (1 mg/ml). Sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically incompatible with infusion fluids containing 20% or more of dextrose, lipid infusions and peritoneal dialysis fluids. Precipitation may occur at dilutions which result in a pH of less than 7.4.
Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Longwick Road, Princes Risborough, Buckinghamshire, HP27 9RR.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
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Fucidin IV
sodium fusidate
Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet: 1. 2. 3. 4. 5. 6. What Fucidin IV is and what it is used for Before you have Fucidin IV How to use Fucidin IV Possible side effects How to store Fucidin IV Further information
1. WHAT FUCIDIN IV IS AND WHAT IT IS USED FOR
This medicine contains sodium fusidate. It is a type of antibiotic. Fucidin IV works by killing germs (bacteria) that cause infections. Fucidin IV is used to treat infections such as: Infections of the skin and wounds Infections of the blood such as septicaemia Infections of the bone and heart tissue Infections of the lungs such as pneumonia Infections connected with the condition cystic fibrosis.
2. BEFORE YOU HAVE FUCIDIN IV
Do not have Fucidin IV If you are allergic (hypersensitive) to fusidic acid or its salts. If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet. Take special care with Fucidin IV Before you have Fucidin IV, tell your doctor: If you are taking statins (medicines to lower blood cholesterol) If you have problems with your liver If you have recently been jaundiced.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
Page 1 of 5
When you are having Fucidin IV your doctor may take regular blood tests in patients on high doses, with liver or bile problems, taking the medicine for a long time or taking other medicines that affect the liver. If you are concerned that your treatment is not as effective as it should be, tell your doctor. As with any antibiotic treatment, long term or repeated use may increase the risk of developing antibiotic resistance. Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. Do not take statins (medicines to lower blood cholesterol) while using this medicine.
You must tell your doctor or pharmacist if you are taking any of the following medicines: Other antibiotics, such as lincomycin and rifampicin. Oral anti-coagulants (medicines to thin your blood). You may be likely to bleed more easily. Your doctor may need to change your dose. Medicines to lower blood cholesterol, such as statins. This may lead to muscle weakness, tenderness or pain. Also see section 4 of this leaflet. Ritonavir or saquinavir, medicines used to treat HIV. Ciclosporin. This medicine is used to reduce the body's immune reactions. Pregnancy and breast-feeding Please ask your doctor or pharmacist for advice before having Fucidin IV: If you are pregnant, or think you are pregnant If you are breast-feeding. Tell your doctor if you become pregnant while having this medicine. Driving and using machines Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines. Important information about some of the ingredients of Fucidin IV Fucidin IV contains: Sodium. Each reconstituted vial contains 73 milligrams (mg) sodium. You should take this into consideration if you are on a controlled sodium diet. Please ask your doctor if you are worried about any of the ingredients in this medicine.
3. HOW TO USE FUCIDIN IV
Fucidin IV will be given to you into your vein by a doctor or nurse. How much Fucidin IV to have Your doctor will prescribe the right dose for you. If you have received more Fucidin IV than you should Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your doctor or nurse straight away. If you have missed a dose of Fucidin IV
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
Page 2 of 5
Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your doctor or nurse. If you have any further questions about using this medicine, please ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fucidin IV can cause side effects, although not everybody gets them. Approximately 3 out of 10 people may experience side effects with Fucidin IV, but many of these are where the medicine is given into the vein. Serious side effects: Rare (affects less than 1 in 1,000 people): allergic reaction. You must get urgent medical help if you have any of the following symptoms: You have difficulty breathing Your face or throat swell Your skin develops a severe rash. Number of people affected not known: You must get urgent medical help if you have any of the following symptoms. You may be experiencing a condition called rhabdomyolysis: You develop muscle weakness You develop muscle pain You develop muscle tenderness. Common (affects less than 1 in 10 people): problems with your liver. You should tell your doctor straight away if you have the following symptoms: Your skin or the whites of your eyes appear yellow. Number of people affected not known: problems with your kidneys. You should tell your doctor straight away if you have the following symptoms: You are not passing water. Number of people affected not known: the level of some cells in your blood may change. You should tell your doctor straight away if you have any of the following symptoms: You develop any unexplained bruising or bleeding You develop persistent or repeated mouth ulcers, sore throats or other infections. Other possible side effects: Common (affect less than 1 in 10 people): Pain or inflammation of the vein where Fucidin IV is given, dizziness, drowsiness. Uncommon (affect less than 1 in 100 people): Headache, rash, itchy rash, itching, loss of appetite, feeling tired, weak or unwell. Number of people affected not known: Pale stools, dark urine, upper right hand side stomach pain. If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE FUCIDIN IV
Keep out of the reach and the sight of children.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
Page 3 of 5
Do not use Fucidin IV after the expiry date on the carton. The expiry date is the last day of that month.
6. FURTHER INFORMATION
What Fucidin IV contains The active ingredient is sodium fusidate. A vial of powder contains 500 mg of sodium fusidate.
The other ingredients are citric acid, disodium edetate, disodium hydrogen phosphate and water for injections.
You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Fucidin IV looks like and contents of the pack Fucidin IV comes in packs of 2 vials. One vial contains sodium fusidate (powder) and the other vial the solution for the infusion. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Princes Risborough, Bucks., HP27 9RR, UK. Manufacturer: LEO Pharma A/S, DK 2750, Ballerup, Denmark. This leaflet was last revised in June 2012
PLEASE TEAR ALONG THE PERFORATIONS AND RETAIN THIS PORTION BEFORE GIVING THE REMAINING LEAFLET TO THE PATIENT.
FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY
Fucidin IV
Sodium Fusidate Ph.Eur. 500mg (equivalent to 480mg fusidic acid) contained in one vial. (The second vial contains buffer solution). Powder for reconstitution and use as an intravenous infusion. The vial of 10 ml sterile phosphate-citrate buffer solution (pH 7.4 - 7.6) contains disodium hydrogen phosphate, citric acid, disodium edetate and water for injections. (When reconstituted with powder vial contains 3.1 mMol sodium and 1.1 mMol phosphate). Shelf-life and storage conditions: The sodium fusidate dry powder is stable for 3 years when stored at room temperature (below 25C) and protected from light. After the sodium fusidate dry powder is dissolved in the buffer solution provided and added to 500ml of infusion fluid , the shelf-life of this solution is 24 hours. When the buffer solution is transferred to the powder vial, this vial should be regarded as a unit dose. The required amount of solution should be used once only and any unused portion discarded.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
Page 4 of 5
Recommended procedure for reconstitution and administration: To reconstitute, dissolve the contents of one vial containing 500 mg sodium fusidate powder (equivalent to 480 mg of fusidic acid) in the 10 ml buffer provided. For adults weighing more than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid. For children and adults weighing less than 50 kg: Add the 10 ml fusidate/buffer solution to 500 ml of infusion fluid. Each dose corresponds to 6-7 ml of the resulting solution per kg bodyweight. The diluted fluid should be infused via a central venous line over 2 hours. If a superficial vein is employed a more prolonged period of at least 6 hours is advisable. This product should be administered intravenously into a wide bore vein with a good blood flow. Excessive doses may cause venospasm, thrombophlebitis and haemolysis of erythrocytes. Both oral and intravenous presentations have been given concurrently with other antibiotics, e.g. cloxacillin, flucloxacillin, ampicillin, methicillin and erythromycin. If additional antibacterial therapy is to be employed, it is recommended that for parenteral administration, separate infusion fluids be used. This product should not be infused with amino acid solutions or in whole blood. In vitro compatibility studies of Fucidin IV with commonly used infusion solutions have been carried out. The results showed that sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically and chemically compatible for at least 24 hours at room temperature with the following infusion solutions (the figure in parenthesis shows the concentration of sodium fusidate in the final admixture): Sodium Chloride Intravenous Infusion BP 0.9% (1-2 mg/ml) Dextrose Intravenous Infusion BP 5% (1-2 mg/ml) Compound Sodium Lactate Intravenous Infusion (Ringer-Lactate Solution) (1 mg/ml) Sodium Lactate Intravenous Infusion BP (1 mg/ml) Sodium Chloride (0.18%) and Dextrose (4%) Intravenous Infusion BP (1 mg/ml) Potassium Chloride (0.3%) and Dextrose (5%) Intravenous Infusion BP (1 mg/ml). Sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically incompatible with infusion fluids containing 20% or more of dextrose, lipid infusions and peritoneal dialysis fluids. Precipitation may occur at dilutions which result in a pH of less than 7.4.
Further information can be found in the Summary of Product Characteristics or from: LEO Pharma, Longwick Road, Princes Risborough, Buckinghamshire, HP27 9RR.
Fucidin IV-Section 4.8 Update-Cholestasis-Clean PIL 25.06.12
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
