TOBRAMYCIN 1 MG/ML SOLUTION FOR INFUSION
Active substance: TOBRAMYCIN
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PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG 34209 Melsungen, Germany
Tobramycin 1 mg/ml
solution for infusion solution for infusion Tobramycin
Read all of this leaflet carefully before you start taking this medicine.
eep this leaflet. You may need to read it again. K f you have any further questions, ask your doctor or pharmacist. I his 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. T f any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. I
Tobramycin 3 mg/ml
In this leaflet:
1. hat Tobramycin 1 mg/ml or Tobramycin 3 mg/ml is and what it is W used for 2. Before you use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml 3. How to use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml 4. Possible side effects 5 How to store Tobramycin 1 mg/ml or Tobramycin 3 mg/ml 6. Further information
1.WHAT TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML IS AND WHAT IT IS USED FOR
Tobramycin 1 mg/ml or Tobramycin 3 mg/ml belong to a group of medicines called antibiotics, that is, they are used to treat severe infections with bacteria that can be killed by the active substance tobramycin. You may receive tobramycin to treat the following diseases: nfections of lungs and the lower airways occurring during in-patient I treatment nfections of lungs and the lower airways in-patients with cystic I fibrosis omplicated and recurrent infections of kidneys, urinary ducts and C bladder nfections within the belly I kin and soft tissue infections, including severe burns S If necessary, other antibiotics may also be included in your therapy.
Other medicines that may also cause damage to kidneys and ear nerve The damaging effect of tobramycin on kidneys and ear nerve may be increased by: ther substances used to treat infections like amphotericin B, polymyxin o B, colistin, cefalotin, aminoglycosides isplatin (an anticancer drug; here a kidney damage can occur even c three or four weeks after administration of these medicines.) iclosporin, tacrolimus (substances suppressing undesirable immune c reactions) apid acting medicines increasing urine flow: furosemide or ethacrynic r acid So administration of these together with or after tobramycin will be avoided as far as possible. Other antibiotics Combination therapy with suitable antibiotics (e.g. with beta-lactams) may markedly strengthen the effect of the treatment. However, the effect of tobramycin will be weakened by penicillin-like antibiotics if your kidney function is severely impaired.
Pregnancy and breast-feeding
Pregnancy If you are pregnant your doctor will give you this medicine only if he/she considers it absolutely necessary. Breast-feeding Although it is rather unlikely that tobramycin is taken up through the gut by suckling babies, your doctor will carefully consider whether nursing or tobramycin therapy should be discontinued.
2.BEFORE YOU USE TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML
Do not use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml
f you are allergic (hypersensitive) to tobramycin, other aminoglycosides i or any of the other ingredients of Tobramycin 1 mg/ml or Tobramycin 3 mg/ml. f you have Myasthenia gravis. i
Driving and using machines
Caution is advised when driving and using machines in view of the possible undesired effects such as dizziness.
Important information about some of the ingredients of Tobramycin 1 mg/ml or Tobramycin 3 mg/ml
Tobramycin 1 mg/ml contains 12.3 mmol (or 283 mg) of sodium in 80 ml. To be taken into consideration by patients on a controlled sodium diet. Tobramycin 3 mg/ml contains 12.3 mmol (or 283 mg) of sodium in 80 ml and 18.5 mmol (or 425 mg) of sodium in 120 ml. To be taken into consideration by patients on a controlled sodium diet.
Take special care with Tobramycin 1 mg/ml or Tobramycin 3 mg/ml
Your doctor will exercise particular caution if you have kidney disease, a mpaired hearing or any abnormalities in your inner ear, i arkinsons disease. P So your doctor should know if any of these applies. As tobramycin may have a damaging effect on your kidneys and your ear nerve, you will be kept under close observation for any signs that may indicate such damage during your therapy. Monitoring of your kidney function, hearing and equilibrium is especially important if you already have or might have a kidney function disorder or if you kidney function seems to worsen during therapy. A combination of tobramycin with rapid acting medicines that increase your urine flow or other medicines that could also cause damage to your kidneys and your ear nerve will be avoided. Monitoring will include idney function, especially if you are elderly or have kidney impairment, k earing, h lood levels of tobramycin as often as possible. b Daily doses will be reduced and/or the time between doses lengthened if signs of kidney impairment appear or if kidney impairment worsens. If kidney impairment gets severe, therapy will be stopped. Tobramycin therapy will also be stopped if any damage to your ear nerve, presenting as ear noise or hearing loss, develops. You should inform your doctor immediately if you experience severe diarrhoea. If a blockade of your muscle function occurs, this can be treated with calcium salts. It will be made sure during treatment that your fluid and electrolyte levels are normal. If you suffer from extended burn wounds, your blood tobramycin level will be especially carefully controlled. If you undergo any rinsing procedures with solutions containing tobramycin or another aminoglycoside on wounds during surgery, this will be taken into account for your tobramycin dose. Your doctor will also exercise particular caution if you are elderly. Paediatric patients Tobramycin will be administered to pre-term and term new-born infants with particular caution. Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following should be paid attention to: Drugs suppressing muscle function (muscle relaxants), ether, blood conserves containing citrate: These may increase the risk that a blockade of nerve and muscle functions occurs. Combination will therefore be avoided if possible. Methoxyflurane anaesthesia The anaesthetist should know before performing anaesthesia with methoxyflurane (an anaesthetic gas) if you have received or are receiving aminoglycosides and avoid to use methoxyflurane if ever possible, because of an increased risk of kidney damage.
3. HOW TO USE TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML
Tobramycin 1 mg/ml or Tobramycin 3 mg/ml is administered by a drip directly into a vein (intravenous infusion). The content of one bottle is preferably administered over a period of 30 minutes. The time period may be up to 60 minutes. Your doctor will determine the appropriate dose for you. The following are commonly used doses:
Dosage in patients with normal kidney function
Adults and adolescents Severe infections 3 mg of tobramycin per kg body weight (BW) per 24 hours, as a single daily dose or divided in equal doses of 1 mg per kg BW every 8 hours. Life-threatening infections Up to 5 mg of tobramycin per kg body weight (BW) per 24 hours, as a single daily dose or divided in equal doses of 1.66 mg per kg BW every 8 hours (or 1.25 mg per kg BW every 6 hours). The dosage should be reduced as soon as clinically indicated. Cystic fibrosis Up to 8 10 mg of tobramycin per kg BW per day Infants, toddlers and children older than one week: 6 7.5 mg of tobramycin per kg BW as a single daily dose or 2 2.5 mg per kg BW every 8 hours or 1.5 1.9 mg per kg BW every 6 hours. Tobramycin can be given as one single daily dose This, however, does not apply to patients with weakened immunity, kidney failure, cystic fibrosis, water in the belly, extensive burns (more than 20 per cent of the skin), and in pregnancy.
Dosage in patients with kidney function impairment
If you have kidney function impairment the tobramycin level in your blood and your kidney function will be monitored carefully and frequently in order to adequately adjust your tobramycin dose. Your doctor knows how to calculate and to adjust the doses you are going to receive. If you are undergoing haemodialysis or peritoneal dialysis your dose is carefully adjusted according to the tobramycin level in your blood.
Severely overweight patients
In these patients the dose is calculated according to the ideal body weight plus 40 percent of weight excess.
Time of treatment
The usual duration of treatment is 7 to 10 days. Longer treatment may be necessary in cases of severe and complicated infections. Your kidney function, hearing and equilibrium will be monitored.
B|BRAUN
15.03.11 07:42
770+771/12608360/0311
If you use more Tobramycin 1 mg/ml or Tobramycin 3 mg/ml than you should
Overdosing may cause damage to kidneys and the ear nerves or a blockage of muscle function (paralysis). In such a case the infusion of tobramycin has to be stopped. The excretion of tobramycin can be forced by dialysis procedures. Blockage of muscle function can be treated by administration of calcium salts. Mechanical ventilation may be necessary in breathing paralysis. In the case of an acute allergic reaction established emergency measures are applied. If you have any further questions on the use of this product, ask your doctor.
6.FURTHER INFORMATION
What Tobramycin 1 mg/ml or Tobramycin 3 mg/ml contain
he active substance is tobramycin. T ml of Tobramycin 1 mg/ml solution for infusion contains 1 mg of 1 tobramycin polyethylene bottle of 80 ml contains 80 mg of tobramycin. 1 ml of Tobramycin 3 mg/ml solution for infusion contains 3 mg of 1 tobramycin 1 polyethylene bottle of 80 ml contains 240 mg of tobramycin. 1 polyethylene bottle of 120 ml contains 360 mg of tobramycin. he other ingredients are: T Tobramycin 1 mg/ml: Sodium chloride Water for injections Sulphuric acid (for pH adjustment) Tobramycin 3 mg/ml Sodium chloride Water for injections Hydrochloric acid (for pH adjustment)
4.POSSIBLE SIDE EFFECTS
Like all medicines, Tobramycin 1 mg/ml or Tobramycin 3 mg/ml can cause side effects, although not everybody gets them. In this leaflet, frequencies of side effects are defined as: Very common: affects more than 1 treated patient in 10 Common: affects 1 to 10 treated patients in 100 Uncommon: affects 1 to 10 treated patients in 1,000 Rare: affects 1 to 10 treated patients in 10,000 Very rare: affects less than 1 treated patient in 10,000 Not known: frequency cannot be estimated from the available data. Tobramycin shows damaging effects on ear nerve and kidneys. Kidney impairment is uncommonly observed in patients treated with tobramycin and will usually resolve after withdrawal of the drug. In most cases damaging effects associated with an excessively high dosage or longlasting treatment, already existing kidney abnormalities or is associated with other substances also having a damaging effect on kidneys. Damaging effects are more likely to occur in the elderly and in patients with fluid deficit. Adverse reactions can largely be avoided by strictly obeying the precautions and careful dosing according to instructions.
What Tobramycin 1 mg/ml or Tobramycin 3 mg/ml look like and contents of the pack
Tobramycin 1 mg/ml or Tobramycin 3 mg/ml is a solution for infusion; i.e. it is administered as a drip through a small tube or cannula placed in a vein. It is a clear colourless solution. Tobramycin 1 mg/ml comes in polyethylene bottles of 80 ml. It is supplied in packs of 10 or 20 bottles. Tobramycin 3 mg/ml comes in polyethylene bottles of 80 ml or 120 ml. It is supplied in packs of 10 or 20 bottles.
Marketing Authorisation Holder
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany Phone: +49/566/71-0 Fax: +49/566/71-4567 Postal address 34209 Melsungen, Germany
The following adverse reactions, which may occur only rarely, may be serious and demand immediate treatment:
evere acute hypersensitivity (allergic) reactions with shock, s earing impairment that may proceed to deafness, h cute kidney failure. a The adverse reactions that might be due to treatment are listed hereafter by frequency Common side effects ncreased count of a certain type of white blood cells (eosinophils) I amage of the inner ear in patients with impaired kidney function, D presenting as giddiness, dizziness, hissing and whistling sounds in the ear, and an impairment of hearing. lood clots and inflammation of veins B ncreased blood levels of some enzymes located in the liver (aspartate I aminotransferase, alanine aminotransferase) idney damage in patients with impaired kidney function K ain and local reactions at the infusion site P Uncommon side effects ow counts of total white blood cells (leukopenia) L eadache H amage of the inner ear in patients with normal kidney function (same D signs as above) eeling sick, sickness F ncreased blood levels of bilirubin and some enzymes located in the liver I (alkaline phosphatase, lactate dehydrogenase) llergic skin rash, itching A idney damage in patients with normal kidney function K Rare side effects ow counts of red blood cells, a certain class of white blood cells L (granulocytes) and blood platelets; increased counts of total white blood cells (leukocytosis) ypersensitivity reactions (skin rash, itching, hives) H ental confusion, loss of orientation M iarrhoea D kin reddening S ever, listlessness F ow blood levels of calcium, magnesium, sodium and potassium L Very rare side effects evere acute general hypersensitivity (allergic) reaction up to shock S evere allergic reaction of the skin and mucous membranes accompanied S by blistering and reddening of the skin (erythema multiforme), which might in very severe cases affect inner organs and might be lifethreatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), hair loss cute kidney failure A Side effects of unknown frequency arge bowel inflammation (may usually be due to other antibiotics), L infection with germs resistant to tobramycin umbness, skin tingling, muscle twitching, convulsion, drowsiness N lockage of muscle function B If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Manufacturer
B. Braun Medical S.A. Carretera de Terrassa 121 08191 Rub (Barcelona), Spain
This medicinal product is authorised in the member states of the EEA under the following names:
Austria Tobramycin B. Braun 1 mg/ml Infusionslsung Tobramycin B. Braun 3 mg/ml Infusionslsung Belgium Tobramycine B. Braun 1 mg/ml Solution pour perfusion / Infusionslsung / Oplossing voor infusie Tobramycine B. Braun 3 mg/ml Solution pour perfusion / Infusionslsung / Oplossing voor infusie Czech Republic Tobramycin B. Braun 1 mg/ml Tobramycin B. Braun 3 mg/ml Germany Tobramycin B. Braun 1 mg/ml Infusionslsung Tobramycin B. Braun 3 mg/ml Infusionslsung Greece Tobramycin B. Braun 1 mg/ml Tobramycin B. Braun 3 mg/ml Finland Tobramycin B. Braun 1 mg/ml infuusioneste, liuos Tobramycin B. Braun 3 mg/ml infuusioneste, liuos France Tobramycine B. Braun 1 mg/ml, solution pour perfusion Tobramycine B. Braun 3 mg/ml, solution pour perfusion Italy Tobramicina B. Braun 1 mg/ml soluzione per infusione Tobramicina B. Braun 3 mg/ml soluzione per infusione Luxembourg Tobramycin B. Braun 1 mg/ml Infusionslsung Tobramycin B. Braun 3 mg/ml Infusionslsung Norway Tobramycin B. Braun 1 mg/ml Infusjonsvske, opplsning Tobramycin B. Braun 3 mg/ml Infusjonsvske, opplsning Poland Tobramycin B. Braun Portugal Tobramicina B. Braun 1 mg/ml soluo para perfuso Tobramicina B. Braun 3 mg/ml soluo para perfuso Slovakia Tobramycin B. Braun 1 mg/ml infzny roztok Tobramycin B. Braun 3 mg/ml infzny roztok United Kingdom Tobramycin 1 mg/ml solution for infusion Tobramycin 3 mg/ml solution for infusion
This leaflet was last approved in 03/2011.
The following information is intended for medical or healthcare professionals only: Tobramycin 1 mg/ml solution for infusion or Tobramycin 3 mg/ml solution for infusion is a ready-to-use formulation. On no account may aminoglycosides be mixed in an infusion solution with beta-lactam antibiotics (e.g. penicillins, cephalosporins), as this may cause chemical-physical inactivation of the combination partner. When tobramycin is administered together with a penicillin or cephalosporin both substances must be administered separately and the recommended dose must be used for each medicinal product. Tobramycin is incompatible with heparin. For intravenous use only. For single use only. Unused solution should be discarded. Only clear solutions free from particles should be used. From the 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 to 8 C. The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system. Refer to section 4.2 of the SPC for information on dosage.
5.HOW TO STORE TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML
Keep out of the reach and sight of children. Do not use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml after the expiry date which is stated on the bottle and the outer carton The expiry date refers to the last day of that month. The abbreviation EXP refers to the expiry date. Only clear solutions free from particles should be used. This medicinal product does not require any special storage conditions. This medicinal product is for single use only. Any unused solution should be discarded. 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.
B|BRAUN
B. Braun Melsungen AG 34209 Melsungen, Germany
15.03.11 07:42
B. Braun Melsungen AG 34209 Melsungen, Germany
Tobramycin 1 mg/ml
solution for infusion solution for infusion Tobramycin
Read all of this leaflet carefully before you start taking this medicine.
eep this leaflet. You may need to read it again. K f you have any further questions, ask your doctor or pharmacist. I his 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. T f any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. I
Tobramycin 3 mg/ml
In this leaflet:
1. hat Tobramycin 1 mg/ml or Tobramycin 3 mg/ml is and what it is W used for 2. Before you use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml 3. How to use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml 4. Possible side effects 5 How to store Tobramycin 1 mg/ml or Tobramycin 3 mg/ml 6. Further information
1.WHAT TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML IS AND WHAT IT IS USED FOR
Tobramycin 1 mg/ml or Tobramycin 3 mg/ml belong to a group of medicines called antibiotics, that is, they are used to treat severe infections with bacteria that can be killed by the active substance tobramycin. You may receive tobramycin to treat the following diseases: nfections of lungs and the lower airways occurring during in-patient I treatment nfections of lungs and the lower airways in-patients with cystic I fibrosis omplicated and recurrent infections of kidneys, urinary ducts and C bladder nfections within the belly I kin and soft tissue infections, including severe burns S If necessary, other antibiotics may also be included in your therapy.
Other medicines that may also cause damage to kidneys and ear nerve The damaging effect of tobramycin on kidneys and ear nerve may be increased by: ther substances used to treat infections like amphotericin B, polymyxin o B, colistin, cefalotin, aminoglycosides isplatin (an anticancer drug; here a kidney damage can occur even c three or four weeks after administration of these medicines.) iclosporin, tacrolimus (substances suppressing undesirable immune c reactions) apid acting medicines increasing urine flow: furosemide or ethacrynic r acid So administration of these together with or after tobramycin will be avoided as far as possible. Other antibiotics Combination therapy with suitable antibiotics (e.g. with beta-lactams) may markedly strengthen the effect of the treatment. However, the effect of tobramycin will be weakened by penicillin-like antibiotics if your kidney function is severely impaired.
Pregnancy and breast-feeding
Pregnancy If you are pregnant your doctor will give you this medicine only if he/she considers it absolutely necessary. Breast-feeding Although it is rather unlikely that tobramycin is taken up through the gut by suckling babies, your doctor will carefully consider whether nursing or tobramycin therapy should be discontinued.
2.BEFORE YOU USE TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML
Do not use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml
f you are allergic (hypersensitive) to tobramycin, other aminoglycosides i or any of the other ingredients of Tobramycin 1 mg/ml or Tobramycin 3 mg/ml. f you have Myasthenia gravis. i
Driving and using machines
Caution is advised when driving and using machines in view of the possible undesired effects such as dizziness.
Important information about some of the ingredients of Tobramycin 1 mg/ml or Tobramycin 3 mg/ml
Tobramycin 1 mg/ml contains 12.3 mmol (or 283 mg) of sodium in 80 ml. To be taken into consideration by patients on a controlled sodium diet. Tobramycin 3 mg/ml contains 12.3 mmol (or 283 mg) of sodium in 80 ml and 18.5 mmol (or 425 mg) of sodium in 120 ml. To be taken into consideration by patients on a controlled sodium diet.
Take special care with Tobramycin 1 mg/ml or Tobramycin 3 mg/ml
Your doctor will exercise particular caution if you have kidney disease, a mpaired hearing or any abnormalities in your inner ear, i arkinsons disease. P So your doctor should know if any of these applies. As tobramycin may have a damaging effect on your kidneys and your ear nerve, you will be kept under close observation for any signs that may indicate such damage during your therapy. Monitoring of your kidney function, hearing and equilibrium is especially important if you already have or might have a kidney function disorder or if you kidney function seems to worsen during therapy. A combination of tobramycin with rapid acting medicines that increase your urine flow or other medicines that could also cause damage to your kidneys and your ear nerve will be avoided. Monitoring will include idney function, especially if you are elderly or have kidney impairment, k earing, h lood levels of tobramycin as often as possible. b Daily doses will be reduced and/or the time between doses lengthened if signs of kidney impairment appear or if kidney impairment worsens. If kidney impairment gets severe, therapy will be stopped. Tobramycin therapy will also be stopped if any damage to your ear nerve, presenting as ear noise or hearing loss, develops. You should inform your doctor immediately if you experience severe diarrhoea. If a blockade of your muscle function occurs, this can be treated with calcium salts. It will be made sure during treatment that your fluid and electrolyte levels are normal. If you suffer from extended burn wounds, your blood tobramycin level will be especially carefully controlled. If you undergo any rinsing procedures with solutions containing tobramycin or another aminoglycoside on wounds during surgery, this will be taken into account for your tobramycin dose. Your doctor will also exercise particular caution if you are elderly. Paediatric patients Tobramycin will be administered to pre-term and term new-born infants with particular caution. Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following should be paid attention to: Drugs suppressing muscle function (muscle relaxants), ether, blood conserves containing citrate: These may increase the risk that a blockade of nerve and muscle functions occurs. Combination will therefore be avoided if possible. Methoxyflurane anaesthesia The anaesthetist should know before performing anaesthesia with methoxyflurane (an anaesthetic gas) if you have received or are receiving aminoglycosides and avoid to use methoxyflurane if ever possible, because of an increased risk of kidney damage.
3. HOW TO USE TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML
Tobramycin 1 mg/ml or Tobramycin 3 mg/ml is administered by a drip directly into a vein (intravenous infusion). The content of one bottle is preferably administered over a period of 30 minutes. The time period may be up to 60 minutes. Your doctor will determine the appropriate dose for you. The following are commonly used doses:
Dosage in patients with normal kidney function
Adults and adolescents Severe infections 3 mg of tobramycin per kg body weight (BW) per 24 hours, as a single daily dose or divided in equal doses of 1 mg per kg BW every 8 hours. Life-threatening infections Up to 5 mg of tobramycin per kg body weight (BW) per 24 hours, as a single daily dose or divided in equal doses of 1.66 mg per kg BW every 8 hours (or 1.25 mg per kg BW every 6 hours). The dosage should be reduced as soon as clinically indicated. Cystic fibrosis Up to 8 10 mg of tobramycin per kg BW per day Infants, toddlers and children older than one week: 6 7.5 mg of tobramycin per kg BW as a single daily dose or 2 2.5 mg per kg BW every 8 hours or 1.5 1.9 mg per kg BW every 6 hours. Tobramycin can be given as one single daily dose This, however, does not apply to patients with weakened immunity, kidney failure, cystic fibrosis, water in the belly, extensive burns (more than 20 per cent of the skin), and in pregnancy.
Dosage in patients with kidney function impairment
If you have kidney function impairment the tobramycin level in your blood and your kidney function will be monitored carefully and frequently in order to adequately adjust your tobramycin dose. Your doctor knows how to calculate and to adjust the doses you are going to receive. If you are undergoing haemodialysis or peritoneal dialysis your dose is carefully adjusted according to the tobramycin level in your blood.
Severely overweight patients
In these patients the dose is calculated according to the ideal body weight plus 40 percent of weight excess.
Time of treatment
The usual duration of treatment is 7 to 10 days. Longer treatment may be necessary in cases of severe and complicated infections. Your kidney function, hearing and equilibrium will be monitored.
B|BRAUN
15.03.11 07:42
770+771/12608360/0311
If you use more Tobramycin 1 mg/ml or Tobramycin 3 mg/ml than you should
Overdosing may cause damage to kidneys and the ear nerves or a blockage of muscle function (paralysis). In such a case the infusion of tobramycin has to be stopped. The excretion of tobramycin can be forced by dialysis procedures. Blockage of muscle function can be treated by administration of calcium salts. Mechanical ventilation may be necessary in breathing paralysis. In the case of an acute allergic reaction established emergency measures are applied. If you have any further questions on the use of this product, ask your doctor.
6.FURTHER INFORMATION
What Tobramycin 1 mg/ml or Tobramycin 3 mg/ml contain
he active substance is tobramycin. T ml of Tobramycin 1 mg/ml solution for infusion contains 1 mg of 1 tobramycin polyethylene bottle of 80 ml contains 80 mg of tobramycin. 1 ml of Tobramycin 3 mg/ml solution for infusion contains 3 mg of 1 tobramycin 1 polyethylene bottle of 80 ml contains 240 mg of tobramycin. 1 polyethylene bottle of 120 ml contains 360 mg of tobramycin. he other ingredients are: T Tobramycin 1 mg/ml: Sodium chloride Water for injections Sulphuric acid (for pH adjustment) Tobramycin 3 mg/ml Sodium chloride Water for injections Hydrochloric acid (for pH adjustment)
4.POSSIBLE SIDE EFFECTS
Like all medicines, Tobramycin 1 mg/ml or Tobramycin 3 mg/ml can cause side effects, although not everybody gets them. In this leaflet, frequencies of side effects are defined as: Very common: affects more than 1 treated patient in 10 Common: affects 1 to 10 treated patients in 100 Uncommon: affects 1 to 10 treated patients in 1,000 Rare: affects 1 to 10 treated patients in 10,000 Very rare: affects less than 1 treated patient in 10,000 Not known: frequency cannot be estimated from the available data. Tobramycin shows damaging effects on ear nerve and kidneys. Kidney impairment is uncommonly observed in patients treated with tobramycin and will usually resolve after withdrawal of the drug. In most cases damaging effects associated with an excessively high dosage or longlasting treatment, already existing kidney abnormalities or is associated with other substances also having a damaging effect on kidneys. Damaging effects are more likely to occur in the elderly and in patients with fluid deficit. Adverse reactions can largely be avoided by strictly obeying the precautions and careful dosing according to instructions.
What Tobramycin 1 mg/ml or Tobramycin 3 mg/ml look like and contents of the pack
Tobramycin 1 mg/ml or Tobramycin 3 mg/ml is a solution for infusion; i.e. it is administered as a drip through a small tube or cannula placed in a vein. It is a clear colourless solution. Tobramycin 1 mg/ml comes in polyethylene bottles of 80 ml. It is supplied in packs of 10 or 20 bottles. Tobramycin 3 mg/ml comes in polyethylene bottles of 80 ml or 120 ml. It is supplied in packs of 10 or 20 bottles.
Marketing Authorisation Holder
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany Phone: +49/566/71-0 Fax: +49/566/71-4567 Postal address 34209 Melsungen, Germany
The following adverse reactions, which may occur only rarely, may be serious and demand immediate treatment:
evere acute hypersensitivity (allergic) reactions with shock, s earing impairment that may proceed to deafness, h cute kidney failure. a The adverse reactions that might be due to treatment are listed hereafter by frequency Common side effects ncreased count of a certain type of white blood cells (eosinophils) I amage of the inner ear in patients with impaired kidney function, D presenting as giddiness, dizziness, hissing and whistling sounds in the ear, and an impairment of hearing. lood clots and inflammation of veins B ncreased blood levels of some enzymes located in the liver (aspartate I aminotransferase, alanine aminotransferase) idney damage in patients with impaired kidney function K ain and local reactions at the infusion site P Uncommon side effects ow counts of total white blood cells (leukopenia) L eadache H amage of the inner ear in patients with normal kidney function (same D signs as above) eeling sick, sickness F ncreased blood levels of bilirubin and some enzymes located in the liver I (alkaline phosphatase, lactate dehydrogenase) llergic skin rash, itching A idney damage in patients with normal kidney function K Rare side effects ow counts of red blood cells, a certain class of white blood cells L (granulocytes) and blood platelets; increased counts of total white blood cells (leukocytosis) ypersensitivity reactions (skin rash, itching, hives) H ental confusion, loss of orientation M iarrhoea D kin reddening S ever, listlessness F ow blood levels of calcium, magnesium, sodium and potassium L Very rare side effects evere acute general hypersensitivity (allergic) reaction up to shock S evere allergic reaction of the skin and mucous membranes accompanied S by blistering and reddening of the skin (erythema multiforme), which might in very severe cases affect inner organs and might be lifethreatening (Stevens-Johnson syndrome, toxic epidermal necrolysis), hair loss cute kidney failure A Side effects of unknown frequency arge bowel inflammation (may usually be due to other antibiotics), L infection with germs resistant to tobramycin umbness, skin tingling, muscle twitching, convulsion, drowsiness N lockage of muscle function B If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Manufacturer
B. Braun Medical S.A. Carretera de Terrassa 121 08191 Rub (Barcelona), Spain
This medicinal product is authorised in the member states of the EEA under the following names:
Austria Tobramycin B. Braun 1 mg/ml Infusionslsung Tobramycin B. Braun 3 mg/ml Infusionslsung Belgium Tobramycine B. Braun 1 mg/ml Solution pour perfusion / Infusionslsung / Oplossing voor infusie Tobramycine B. Braun 3 mg/ml Solution pour perfusion / Infusionslsung / Oplossing voor infusie Czech Republic Tobramycin B. Braun 1 mg/ml Tobramycin B. Braun 3 mg/ml Germany Tobramycin B. Braun 1 mg/ml Infusionslsung Tobramycin B. Braun 3 mg/ml Infusionslsung Greece Tobramycin B. Braun 1 mg/ml Tobramycin B. Braun 3 mg/ml Finland Tobramycin B. Braun 1 mg/ml infuusioneste, liuos Tobramycin B. Braun 3 mg/ml infuusioneste, liuos France Tobramycine B. Braun 1 mg/ml, solution pour perfusion Tobramycine B. Braun 3 mg/ml, solution pour perfusion Italy Tobramicina B. Braun 1 mg/ml soluzione per infusione Tobramicina B. Braun 3 mg/ml soluzione per infusione Luxembourg Tobramycin B. Braun 1 mg/ml Infusionslsung Tobramycin B. Braun 3 mg/ml Infusionslsung Norway Tobramycin B. Braun 1 mg/ml Infusjonsvske, opplsning Tobramycin B. Braun 3 mg/ml Infusjonsvske, opplsning Poland Tobramycin B. Braun Portugal Tobramicina B. Braun 1 mg/ml soluo para perfuso Tobramicina B. Braun 3 mg/ml soluo para perfuso Slovakia Tobramycin B. Braun 1 mg/ml infzny roztok Tobramycin B. Braun 3 mg/ml infzny roztok United Kingdom Tobramycin 1 mg/ml solution for infusion Tobramycin 3 mg/ml solution for infusion
This leaflet was last approved in 03/2011.
The following information is intended for medical or healthcare professionals only: Tobramycin 1 mg/ml solution for infusion or Tobramycin 3 mg/ml solution for infusion is a ready-to-use formulation. On no account may aminoglycosides be mixed in an infusion solution with beta-lactam antibiotics (e.g. penicillins, cephalosporins), as this may cause chemical-physical inactivation of the combination partner. When tobramycin is administered together with a penicillin or cephalosporin both substances must be administered separately and the recommended dose must be used for each medicinal product. Tobramycin is incompatible with heparin. For intravenous use only. For single use only. Unused solution should be discarded. Only clear solutions free from particles should be used. From the 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 to 8 C. The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system. Refer to section 4.2 of the SPC for information on dosage.
5.HOW TO STORE TOBRAMYCIN 1 MG/ML OR TOBRAMYCIN 3 MG/ML
Keep out of the reach and sight of children. Do not use Tobramycin 1 mg/ml or Tobramycin 3 mg/ml after the expiry date which is stated on the bottle and the outer carton The expiry date refers to the last day of that month. The abbreviation EXP refers to the expiry date. Only clear solutions free from particles should be used. This medicinal product does not require any special storage conditions. This medicinal product is for single use only. Any unused solution should be discarded. 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.
B|BRAUN
B. Braun Melsungen AG 34209 Melsungen, Germany
15.03.11 07:42
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.
