COLOMYCIN INJECTION 2 MILLION INTERNATIONAL UNITS. POWDER FOR SOLN FOR INJ INFUSION OR INHALATION
Active substance: COLISTIMETHATE SODIUM
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PACKAGE LEAFLET: INFORMATION FOR THE USER COLOMYCIN INJECTION 1 million or 2 million International Units Powder for solution for injection, infusion or inhalation Colistimethate Sodium
treat serious infections due to certain types of bacteria. These infections include some pneumonias and some infections of the bladder and kidneys. Colomycin is not often used to treat these types of infections but may be used when other antibiotics are not suitable for some reason. For example, if the person who is infected is allergic to the other types of antibiotics or if the bacteria are resistant to these other antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLOMYCIN
or are planning to have a baby ask your doctor for advice before taking this medicine. Are you breast-feeding? Small amounts of Colomycin enter the milk. If you cannot stop breast-feeding while you take Colomycin, you should watch your baby carefully for any signs of illness and tell your doctor if you notice anything wrong. Driving and using machines When Colomycin is given into a vein there may be side effects such as dizziness, confusion or problems with vision. If these occur, you should not drive or operate machinery.
3. HOW TO USE COLOMYCIN
Do not use Colomycin: If you are allergic to Colomycin (also known as colistin or colistimethate sodium) or to another antibiotic called polymyxin B. If you have myasthenia gravis (a disease causing weakened muscles and excessive tiredness) Warnings and precautions Talk to your doctor before using Colomycin if you have porphyria (a rare, often inherited disorder), Talk to your doctor before using Colomycin if you have kidney problems. Some people may experience a feeling of tightness in the chest due to narrowing of the airways when inhaling Colomycin. Your doctor may prescribe other medicines for inhalation directly before or after using Colomycin; in order to prevent or treat this. Other medicines and Colomycin Tell your doctor if you are taking, have recently taken or might take any other medicines. If you are taking any of the following medicines, you may or may not be able to take Colomycin. Sometimes the other medicines must be stopped (if only for a while) or you may need a lower dose of Colomycin or you may need to be monitored while you are taking Colomycin. In some cases, the level of Colomycin in your blood may have to be measured from time to time to make sure that you are having the right dose. Are you taking other antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin and netilmicin)? Having Colomycin at the same time as an aminoglycoside antibiotic can increase the risk of kidney problems or cause side effects in the ears and other parts of the nervous system (see section 4 of this leaflet). Are you taking other antibiotics called cephalosporins? Taking cephalosporin antibiotics at the same time as Colomycin can increase the risk of kidney problems. Are you receiving muscle relaxant medicines? These are most usually used during a general anaesthetic so you should make sure that you tell the anaesthetist that you are having Colomycin before you have an operation. Having a muscle relaxing drug and Colomycin together can increase and prolong the muscle relaxing effects. If you are likely to be given ether (a substance sometimes used as an anaesthetic) for any reason, please tell your doctor that you are also being treated with Colomycin. Pregnancy and breast-feeding Colomycin is not known to harm the unborn child but, like all medicines, it will only be given to a pregnant woman if it is really needed. If you are pregnant, think you may be pregnant
times a day with doses about 8 hours apart. The maximum dose is 6 million units in one day. Lower doses are usually needed for people with kidney problems. This is because the usual recommended dose can lead to high levels of Colomycin in their blood which increases the risk of some side effects. Your doctor may take some blood samples and do some tests to make sure your Colomycin dose is correct. Sometimes it may also be necessary to measure blood levels of Colomycin in newborn babies and in people with cystic fibrosis. Method of administration Colomycin is given by injection mainly in hospitals. If you are to treat yourself at home, your doctor or nurse will show you how to dissolve the powder and inject the right dose of solution. Duration of treatment Your doctor will decide how long your treatment should last. For use by infusion or injection, a minimum of 5 days treatment is recommended. For treatment by infusion or injection of infections in patients with cystic fibrosis, treatment should be continued for up to 12 days. For nebulised use your doctor will advise on the course of the treatment. When treating bacterial infections it is important to complete the full course of treatment so as to prevent worsening of the existing infection. If you use more Colomycin than you should If you think that you have given yourself too much Colomycin, you should contact your doctor or nurse immediately for advice or, if they are not available, contact or go to your nearest hospital accident and emergency department. If too much Colomycin is accidentally given, the side effects can be serious and can include kidney problems, muscle weakness and difficulty (or even stopping) breathing. If you are being treated in hospital or at home by a doctor or nurse and think that you may have missed a dose or been given too much Colomycin, please ask your doctor, nurse or pharmacist about this. If you forget to use Colomycin If you are treating yourself and have missed any doses, you should give the missed dose as soon as you remember and then give the next dose 8 hours later if using Colomycin three times a day, or 12 hours later if using Colomycin twice a day. Carry on from there as instructed. Do not take a double dose to make up forgotten dose. If you stop using Colomycin Do not stop your treatment early unless your doctor says you can. Your doctor will decide how long your treatment should last. If you have any further questions on the use of this medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
narrowing of the airways and loss of consciousness. If you experience signs of an allergic reaction you should seek urgent medical attention. Less severe allergic reactions include skin rashes that appear later during treatment. Side effects associated with injecting Colomycin into a vein Side effects that affect the nervous system are more likely to occur when the dose of Colomycin is too high, in people who have poor kidneys or in those who are also taking muscle relaxants or other medicines with a similar effect on how the nerves work. The most serious of these possible side effects in the nervous system is inability to breathe because of paralysis of the chest muscles. If you experience any difficulty breathing you should seek urgent medical attention. Other possible side effects include numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including faintness and flushing), slurred speech, problems with vision, confusion and mental problems (including loss of sense of reality). There can be reactions at the site of the injection, such as irritation. Kidney problems may also occur. These are especially likely in people who already have poor kidneys, or who are given Colomycin at the same time as other medicines that can cause side effects in the kidneys or who are given a dose that is too high. These problems will normally get better if treatment is stopped or the dose of Colomycin is reduced. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Side effects associated with inhaling Colomycin (nebulisation) The risk of side effects is usually much less when it is given by inhalation because very little Colomycin usually reaches the bloodstream when it is given this way. Possible side effects include coughing, a feeling of tightness in the chest due to narrowing of the airways, sore mouth or throat and thrush (Candida) infections of the mouth or throat. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE COLOMYCIN
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. 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. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Colomycin is and what it is used for 2. What you need to know before you use Colomycin 3. How to use Colomycin 4. Possible side effects 5. How to store Colomycin 6. Contents of the pack and other information
1. WHAT COLOMYCIN IS AND WHAT IT IS USED FOR
Depending on the reason it is being given (see section 1 of this leaflet) Colomycin may be given by fast injection (over 5 minutes into a special kind of tube in a vein) or slow injection (infusion over about 30 minutes) into a vein. Colomycin can also be breathed into the lungs as a fine spray made using a machine called a nebuliser. The droplets of the spray produced by the nebuliser are small enough to enter the lungs so that Colomycin can reach the site of the bacterial infection. Always use Colomycin exactly as your doctor has told you. Check with your doctor if you are not sure. For use in a nebuliser: Dose When Colomycin is to be given by inhalation using a nebuliser, the usual dose for children under two years of age is 500,000 to one million units given twice a day. In most older children and adults, the dose is one or two million units twice a day, with a maximum of two million units three times a day. Method of administration If you are treating yourself at home, your doctor or nurse will show you how to use Colomycin in your nebuliser when you first start the treatment. The following are general instructions. The plastic cap is flipped open and the foil seal carefully ripped from around the top of the vial to remove it completely. The rubber bung is taken out carefully and sterile water or sterile salt water (saline) is added to each vial to dissolve the powder as follows: 1 million unit vial: 2ml sterile water / saline 2 million unit vial: 4ml sterile water / saline The solution is then poured into the nebuliser. IMPORTANT: Do not mix Colomycin with any other product for nebulisation at the same time. For use by infusion or injection: Dose When Colomycin is being given into a vein to treat serious infections (see section 1 of this leaflet), the dose is chosen according to the age of the person to be treated, their body weight, how well their kidneys are working and the type of infection that is being treated. The usual dose in children and adults weighing up to 60 kg is 50,000 to 75,000 units for each kilogram of their body weight each day. This dose is divided into three doses given about 8 hours apart. The usual dose in people who weigh more than 60 kg is 1 to 2 million units given three
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 date of that month. Do not store the vials above 25C. Keep the vials in the outer carton in order to protect from light. Colomycin solutions for injection should be used immediately after preparation. Colomycin solutions for inhalation should preferably be given immediately. If this is not possible, solutions should not be stored for longer than 24 hours in a refrigerator. Any remaining solution should 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Colomycin contains Each vial contains the active substance colistimethate sodium (also called colistin) as an amount of powder equivalent to one million or two million units. There are no other ingredients. This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e. essentially sodium free. What Colomycin looks like and contents of the pack Colomycin, a powder for solution for injection, infusion or inhalation, is supplied as a creamy white powder in single dose vials of either: 1 million units of colistimethate sodium per vial: red cap (1.0 MIU) 2 million units of colistimethate sodium per vial: lilac cap (2.0 MIU) Each box contains ten vials. Marketing Authorisation Holder Forest Laboratories UK Limited Riverbridge House Anchor Boulevard Crossways Business Park Dartford Kent DA2 6SL UK Manufacturer and site of batch release Penn Pharmaceutical Services Tredegar Gwent NP22 3AA UK This leaflet was last revised in Month
Colomycin contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins. Colomycin works by killing some types of bacteria that can cause various sorts of infections in people. Like all antibiotics, Colomycin is only able to kill some types of bacteria so it is only suitable for treating some types of infection. Colomycin can be used to treat chest infections in adults and children who have cystic fibrosis when these infections are due to a bacterium called Pseudomonas aeruginosa. Colomycin is usually given to these patients by inhalation (nebulisation). That is, they breathe in droplets of Colomycin solution as a fine spray and the droplets enter the lungs to reach the places where the bacteria are causing infection. Colomycin is sometimes given to adults and children as a solution into a vein in order to
Keep this medicine out of the sight and reach of children.
10/2012
Other sources of information: Other formats: To listen to or to request a copy of this leaet in Braille, large print or audio please call free of charge: 0800 198 5000 (UK only) Please be ready to give the following information:
Product Name Reference Number 0108/5006
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions Whether Colomycin is given into a vein or by inhalation, an allergic reaction is possible. Serious allergic reactions can happen even with the very first dose and can include rapid development of rashes, swelling of the face, tongue and neck, inability to breathe due to
Colomycin Injection 1 million International Units
Colomycin Injection 2 million International Units 0108/0122 This is a service provided by the Royal National Institute of Blind People. Patients in Ireland should telephone Forest Laboratories UK Ltd. on +44 (0) 1322 421800
0000
treat serious infections due to certain types of bacteria. These infections include some pneumonias and some infections of the bladder and kidneys. Colomycin is not often used to treat these types of infections but may be used when other antibiotics are not suitable for some reason. For example, if the person who is infected is allergic to the other types of antibiotics or if the bacteria are resistant to these other antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE COLOMYCIN
or are planning to have a baby ask your doctor for advice before taking this medicine. Are you breast-feeding? Small amounts of Colomycin enter the milk. If you cannot stop breast-feeding while you take Colomycin, you should watch your baby carefully for any signs of illness and tell your doctor if you notice anything wrong. Driving and using machines When Colomycin is given into a vein there may be side effects such as dizziness, confusion or problems with vision. If these occur, you should not drive or operate machinery.
3. HOW TO USE COLOMYCIN
Do not use Colomycin: If you are allergic to Colomycin (also known as colistin or colistimethate sodium) or to another antibiotic called polymyxin B. If you have myasthenia gravis (a disease causing weakened muscles and excessive tiredness) Warnings and precautions Talk to your doctor before using Colomycin if you have porphyria (a rare, often inherited disorder), Talk to your doctor before using Colomycin if you have kidney problems. Some people may experience a feeling of tightness in the chest due to narrowing of the airways when inhaling Colomycin. Your doctor may prescribe other medicines for inhalation directly before or after using Colomycin; in order to prevent or treat this. Other medicines and Colomycin Tell your doctor if you are taking, have recently taken or might take any other medicines. If you are taking any of the following medicines, you may or may not be able to take Colomycin. Sometimes the other medicines must be stopped (if only for a while) or you may need a lower dose of Colomycin or you may need to be monitored while you are taking Colomycin. In some cases, the level of Colomycin in your blood may have to be measured from time to time to make sure that you are having the right dose. Are you taking other antibiotics called aminoglycosides (which include gentamicin, tobramycin, amikacin and netilmicin)? Having Colomycin at the same time as an aminoglycoside antibiotic can increase the risk of kidney problems or cause side effects in the ears and other parts of the nervous system (see section 4 of this leaflet). Are you taking other antibiotics called cephalosporins? Taking cephalosporin antibiotics at the same time as Colomycin can increase the risk of kidney problems. Are you receiving muscle relaxant medicines? These are most usually used during a general anaesthetic so you should make sure that you tell the anaesthetist that you are having Colomycin before you have an operation. Having a muscle relaxing drug and Colomycin together can increase and prolong the muscle relaxing effects. If you are likely to be given ether (a substance sometimes used as an anaesthetic) for any reason, please tell your doctor that you are also being treated with Colomycin. Pregnancy and breast-feeding Colomycin is not known to harm the unborn child but, like all medicines, it will only be given to a pregnant woman if it is really needed. If you are pregnant, think you may be pregnant
times a day with doses about 8 hours apart. The maximum dose is 6 million units in one day. Lower doses are usually needed for people with kidney problems. This is because the usual recommended dose can lead to high levels of Colomycin in their blood which increases the risk of some side effects. Your doctor may take some blood samples and do some tests to make sure your Colomycin dose is correct. Sometimes it may also be necessary to measure blood levels of Colomycin in newborn babies and in people with cystic fibrosis. Method of administration Colomycin is given by injection mainly in hospitals. If you are to treat yourself at home, your doctor or nurse will show you how to dissolve the powder and inject the right dose of solution. Duration of treatment Your doctor will decide how long your treatment should last. For use by infusion or injection, a minimum of 5 days treatment is recommended. For treatment by infusion or injection of infections in patients with cystic fibrosis, treatment should be continued for up to 12 days. For nebulised use your doctor will advise on the course of the treatment. When treating bacterial infections it is important to complete the full course of treatment so as to prevent worsening of the existing infection. If you use more Colomycin than you should If you think that you have given yourself too much Colomycin, you should contact your doctor or nurse immediately for advice or, if they are not available, contact or go to your nearest hospital accident and emergency department. If too much Colomycin is accidentally given, the side effects can be serious and can include kidney problems, muscle weakness and difficulty (or even stopping) breathing. If you are being treated in hospital or at home by a doctor or nurse and think that you may have missed a dose or been given too much Colomycin, please ask your doctor, nurse or pharmacist about this. If you forget to use Colomycin If you are treating yourself and have missed any doses, you should give the missed dose as soon as you remember and then give the next dose 8 hours later if using Colomycin three times a day, or 12 hours later if using Colomycin twice a day. Carry on from there as instructed. Do not take a double dose to make up forgotten dose. If you stop using Colomycin Do not stop your treatment early unless your doctor says you can. Your doctor will decide how long your treatment should last. If you have any further questions on the use of this medicine, ask your doctor.
4. POSSIBLE SIDE EFFECTS
narrowing of the airways and loss of consciousness. If you experience signs of an allergic reaction you should seek urgent medical attention. Less severe allergic reactions include skin rashes that appear later during treatment. Side effects associated with injecting Colomycin into a vein Side effects that affect the nervous system are more likely to occur when the dose of Colomycin is too high, in people who have poor kidneys or in those who are also taking muscle relaxants or other medicines with a similar effect on how the nerves work. The most serious of these possible side effects in the nervous system is inability to breathe because of paralysis of the chest muscles. If you experience any difficulty breathing you should seek urgent medical attention. Other possible side effects include numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including faintness and flushing), slurred speech, problems with vision, confusion and mental problems (including loss of sense of reality). There can be reactions at the site of the injection, such as irritation. Kidney problems may also occur. These are especially likely in people who already have poor kidneys, or who are given Colomycin at the same time as other medicines that can cause side effects in the kidneys or who are given a dose that is too high. These problems will normally get better if treatment is stopped or the dose of Colomycin is reduced. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Side effects associated with inhaling Colomycin (nebulisation) The risk of side effects is usually much less when it is given by inhalation because very little Colomycin usually reaches the bloodstream when it is given this way. Possible side effects include coughing, a feeling of tightness in the chest due to narrowing of the airways, sore mouth or throat and thrush (Candida) infections of the mouth or throat. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE COLOMYCIN
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. 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. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. What is in this leaflet 1. What Colomycin is and what it is used for 2. What you need to know before you use Colomycin 3. How to use Colomycin 4. Possible side effects 5. How to store Colomycin 6. Contents of the pack and other information
1. WHAT COLOMYCIN IS AND WHAT IT IS USED FOR
Depending on the reason it is being given (see section 1 of this leaflet) Colomycin may be given by fast injection (over 5 minutes into a special kind of tube in a vein) or slow injection (infusion over about 30 minutes) into a vein. Colomycin can also be breathed into the lungs as a fine spray made using a machine called a nebuliser. The droplets of the spray produced by the nebuliser are small enough to enter the lungs so that Colomycin can reach the site of the bacterial infection. Always use Colomycin exactly as your doctor has told you. Check with your doctor if you are not sure. For use in a nebuliser: Dose When Colomycin is to be given by inhalation using a nebuliser, the usual dose for children under two years of age is 500,000 to one million units given twice a day. In most older children and adults, the dose is one or two million units twice a day, with a maximum of two million units three times a day. Method of administration If you are treating yourself at home, your doctor or nurse will show you how to use Colomycin in your nebuliser when you first start the treatment. The following are general instructions. The plastic cap is flipped open and the foil seal carefully ripped from around the top of the vial to remove it completely. The rubber bung is taken out carefully and sterile water or sterile salt water (saline) is added to each vial to dissolve the powder as follows: 1 million unit vial: 2ml sterile water / saline 2 million unit vial: 4ml sterile water / saline The solution is then poured into the nebuliser. IMPORTANT: Do not mix Colomycin with any other product for nebulisation at the same time. For use by infusion or injection: Dose When Colomycin is being given into a vein to treat serious infections (see section 1 of this leaflet), the dose is chosen according to the age of the person to be treated, their body weight, how well their kidneys are working and the type of infection that is being treated. The usual dose in children and adults weighing up to 60 kg is 50,000 to 75,000 units for each kilogram of their body weight each day. This dose is divided into three doses given about 8 hours apart. The usual dose in people who weigh more than 60 kg is 1 to 2 million units given three
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 date of that month. Do not store the vials above 25C. Keep the vials in the outer carton in order to protect from light. Colomycin solutions for injection should be used immediately after preparation. Colomycin solutions for inhalation should preferably be given immediately. If this is not possible, solutions should not be stored for longer than 24 hours in a refrigerator. Any remaining solution should 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Colomycin contains Each vial contains the active substance colistimethate sodium (also called colistin) as an amount of powder equivalent to one million or two million units. There are no other ingredients. This medicinal product contains less than 1mmol sodium (23mg) per vial, i.e. essentially sodium free. What Colomycin looks like and contents of the pack Colomycin, a powder for solution for injection, infusion or inhalation, is supplied as a creamy white powder in single dose vials of either: 1 million units of colistimethate sodium per vial: red cap (1.0 MIU) 2 million units of colistimethate sodium per vial: lilac cap (2.0 MIU) Each box contains ten vials. Marketing Authorisation Holder Forest Laboratories UK Limited Riverbridge House Anchor Boulevard Crossways Business Park Dartford Kent DA2 6SL UK Manufacturer and site of batch release Penn Pharmaceutical Services Tredegar Gwent NP22 3AA UK This leaflet was last revised in Month
Colomycin contains the active substance colistimethate sodium. Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins. Colomycin works by killing some types of bacteria that can cause various sorts of infections in people. Like all antibiotics, Colomycin is only able to kill some types of bacteria so it is only suitable for treating some types of infection. Colomycin can be used to treat chest infections in adults and children who have cystic fibrosis when these infections are due to a bacterium called Pseudomonas aeruginosa. Colomycin is usually given to these patients by inhalation (nebulisation). That is, they breathe in droplets of Colomycin solution as a fine spray and the droplets enter the lungs to reach the places where the bacteria are causing infection. Colomycin is sometimes given to adults and children as a solution into a vein in order to
Keep this medicine out of the sight and reach of children.
10/2012
Other sources of information: Other formats: To listen to or to request a copy of this leaet in Braille, large print or audio please call free of charge: 0800 198 5000 (UK only) Please be ready to give the following information:
Product Name Reference Number 0108/5006
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions Whether Colomycin is given into a vein or by inhalation, an allergic reaction is possible. Serious allergic reactions can happen even with the very first dose and can include rapid development of rashes, swelling of the face, tongue and neck, inability to breathe due to
Colomycin Injection 1 million International Units
Colomycin Injection 2 million International Units 0108/0122 This is a service provided by the Royal National Institute of Blind People. Patients in Ireland should telephone Forest Laboratories UK Ltd. on +44 (0) 1322 421800
0000
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.
