Cefotaxime 2g Powder For Solution For Injection Or Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cefotaxime 500 mg Powder for solution for injection Cefotaxime 1g Powder for solution for injection Cefotaxime 2g Powder for solution for injection/infusion
Cefotaxime
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or healthcare professional.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.
In this leaflet:
1. What Cefotaxime is and what it is used for
2. Before you use Cefotaxime
3. How to use Cefotaxime
4. Possible side effects
5. How to store Cefotaxime
6. Further information
1. WHAT CEFOTAXIME IS AND WHAT IT IS USED FOR
Cefotaxime powder for solution for injection or infusion is an antibiotic belonging to a group called “cephalosporins”. It is generally effective to fight a range of micro-organism. It is used for the treatment of a range of serious bacterial infections of
• the lungs (pneumonia)
• the kidneys
• the blood stream (septicaemia)
• the membranes covering the brain (meningitis)
• the abdomen
• the skin and soft tissue
• the genitals with gonococci.
• preoperative prophylaxis in colorectal surgery
2. BEFORE YOU USE CEFOTAXIME Do not use Cefotaxime
- if you are allergic (hypersensitive) to cefotaxime, any other cephalosporins or any of the other ingredients of Cefotaxime
- if you previously had an allergic reaction to penicillin or any other beta-lactam antibiotic.
Take special care with Cefotaxime
Tell your doctor or healthcare professional if:
• you have ever had an allergic reaction to penicillin or other medicines from the penicillin family (beta-lactam-antibiotics),
• you suffer from severe allergies or asthma,
• you develop severe persistent (bloody) diarrhoea. You may have an inflammation of the large intestine caused by the use of cefotaxime. In that case, the use of Cefotaxime
must be stopped immediately. Do not take medicines that reduce bowel movements.
• you have kidney problems
• you are on a low-sodium (low salt) diet.
If any of these apply to you, your doctor may want to change your treatment or give you special advice.
If given as an injection into the muscle:
Your doctor may consider it necessary to inject this medicine into a muscle. In this case, the doctor will add lidocaine to the injection to make it less painful. However, this method of administering the injection will not be suitable for everyone and should not be given:
• to infants under 30 months,
• if you are allergic (hypersensitive) to lidocaine,
• if you have irregular heart beat,
• if you have heart problems which can cause shortness of breath or ankle swelling.
Please inform your doctor if one of these applies to you so that your doctor can decide on the form of application.
This medicine can alter the results of some blood and urine tests If you are having blood tests (such as Coombs' test) or urinary sugar tests (the Fehling's type which test for reducing sugars) tell your doctor you are taking this medicine as this medicine may cause false positive results.
Your doctor may decide to do tests on your blood if you are given Cefotaxime for longer than 7 days.
Using other medicines
Please tell your doctor or healthcare professional if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Concomitant intake of
- other antibiotics (such as penicillins, aminoglycosides, tetracyclines, erythromycin and chloramphenicol)
- diuretics (e. g. furosemide)
- probenecid (for the treatment of gout and arthritis)
may increase or decrease the effect of Cefotaxime. Inform your doctor if you are in treatment with these medicines.
The efficacy of oral contraceptives may be decreased by concomitant use of cefotaxime. Therefore during treatment with Cefotaxime additional contraceptive methods should be used.
As with other cephalosporins a positive Coombs' test, which means a false positive reaction for glucose in urine, may occur.
Using Cefotaxime with food and drink
Cefotaxime can be used with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or are planning to become pregnant, your doctor has to determine if a treatment with Cefotaxime is suitable for you.
Cefotaxime excretes in breast milk in low concentrations. Therefore it should not be used during breast-feeding.
Driving and using machines
Cefotaxime has minor or negligible influence on the ability to drive and use machines. Side effects like dizziness may affect your ability to drive and use machines.
Important information about some of the ingredients of Cefotaxime
This medicinal product contains 2.09 mmol/g mmol (or 48 mg) sodium per single dose. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE CEFOTAXIME
Cefotaxime is normally given by a doctor or nurse.
You should check with your doctor or healthcare professional if you are not sure.
Cefotaxime should always be administered intravenously (in a vein) or intra muscular (in a muscle). The injection will always be administered by a doctor.
Dose, method of application and intervals between injections depend on the sensitivity of the microorganism, the severity of your infection and your condition.
If you use more Cefotaxime than you should
This is not likely, as the injection is given to you by a doctor.
If you feel bad after administration of the injection, please contact your doctor immediately.
If you forget to use Cefotaxime
Not relevant, as the injection is given to you by a doctor.
If you stop using Cefotaxime
The doctor will continue treatment with Cefotaxime until the infection treated is relieved.
If you have any further questions on the use of this product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Cefotaxime can cause side effects, although not everybody gets them.
Very common: Common: Uncommon: Rare:
Very rare:
Not known:
affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less then 1 user in 10,000
frequency cannot be estimated from the available data
Very common side effects: Transient pain at the injection site.
Common side effects:
Fungal infection, low platelet count, inflammation of your veins (thrombophlebitis), diarrhoea (watery or bloody), allergic reactions including skin reactions such as skin rash, hives and itching, drug fever, changes in liver values.
Uncommon side effects:
Changes in the amount of white blood cells (which may cause frequent infections, fever, severe chills, sore throat, or mouth ulcers), positive Coombs'test (false positive reaction for glucose in urine), feeling sick, vomiting, stomach pain, loss of appetite, reversible inflammation of the kidneys.
Rare side effects:
Long-term use of Cefotaxime may result in a resistance towards the active substance Cefotaxime; reduced number of red blood cells and certain white blood cells (granulocytopenia); reactions called “Jarisch-Herxhemier” which includes fever, shivering, headache and joint pain; a
brain disease (encephalopathy) may occur in patients with impaired kidney function. This disease may include symptoms like dizziness, convulsions, abnormal movements and tiredness,
Severe allergic reactions as swelling of the face, throat, and lips (angiooedema), bronchial spasms, nausea - possibly cumulating to allergic shock.
Irregular heartbeat, a severe inflammation in areas of the large intestine, severe skin reactions with large blisters that coalesce, impaired kidney function.
Very rare side effects:
Agranulocytosis (serious condition in which white blood cells decrease in number or disappear altogether).
Unknown frequency:
Headache.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.
5. HOW TO STORE CEFOTAXIME
Keep out of the reach and sight of children.
Do not store at temperatures above 25°C. Store in the original package in order to protect from light.
Do not use Cefotaxime after the expiry date which is stated on the cartonafter “EXP”. The expiry date refers to the last day of that month.
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.
6. FURTHER INFORMATION What Cefotaxime contains
1 vial Cefotaxime, 500 mg contains 0.524 g cefotaxime sodium, corresponding to 500 mg cefotaxime.
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1 vial Cefotaxime, 1 g contains 1.048 g cefotaxime sodium, corresponding to 1 g | |
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cefotaxime. | |
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1 vial Cefotaxime, 2 g contains 2.096 g cefotaxime sodium, corresponding to 2 g | |
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cefotaxime. | |
What Cefotaxime looks like and contents of the pack
Appearance of the powder: White to slightly yellow powder.
Pack sizes:
500 mg: 10 vials
1 g: 10 vials
2 g: 10 vials
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer
Agila Specialties Polska Sp.Z.o.o.
10, Daniszewska Str 03-230 Warsaw Poland
This medicinal product is authorised in the Member States of the EEA under the following names:
Cefotaxime 500 mg Powder for solution for injection
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Name |
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The |
Cefotaxime FarmaPlus 500 mg Poeder voor oplossing voor injectie |
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Netherlands | |
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Poland |
Cefotaxime FarmaPlus |
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United |
Cefotaxime 500 mg Powder for solution for injection |
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Kingdom |
Cefotaxime 1g Powder for solution for injection
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Country |
Name |
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Denmark |
Cefotaxime Farmaplus 1 g Pulvertil injektionsv^ske, opl0sning |
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Finland |
Cefotaxime FarmaPlus 1 g Injektiokuiva-aine,liuostavarten |
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The |
Cefotaxime FarmaPlus 1 g Poeder voor oplossing voor injectie |
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Netherlands | |
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Norway |
Cefotaxime FarmaPlus 1 g Pulvertil injeksjonsv^ske, oppl0sning |
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Poland |
Cefotaxime FarmaPlus |
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Sweden |
Cefotaxime FarmaPlus 1 g Pulver till injektionsvatska, losning |
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United |
Cefotaxime1g Powder for solution for injection |
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Kingdom |
Cefotaxime 2g Powder for solution for injection/infusion
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Country |
Name |
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Denmark |
Cefotaxime Farmaplus 2 g Pulvertil injektions-/infusionsvsske, opl0sning |
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Finland |
Cefotaxime FarmaPlus 2 g Injektio-tai infuusiokuiva-aine liuosta varten |
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The |
Cefotaxime FarmaPlus 2 g Poeder voor oplossing voor injectie of infusie |
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Netherlands | |
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Norway |
Cefotaxime FarmaPlus 2 g Pulvertil injeksjons-/infusjonsvsske, oppl0sning |
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Poland |
Cefotaxime FarmaPlus |
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Sweden |
Cefotaxime FarmaPlus 2 g Pulver till injektions-/infusionsvatska, losning |
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United |
Cefotaxime 2g Powder for solution for injection/infusion |
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Kingdom |
This leaflet was last revised in 02/2015
The following information is intended for medical or healthcare professionals only:
Cefotaxime may be administered by intravenous bolus injection, by intravenous infusion, or by intramuscular injection, after reconstitution of the solution according to the directions given below. Dosage, route and frequency of administration should be based on the severity of the infection, susceptibility of the causative organism and the patient's condition. Therapy may be started before the results of sensitivity tests are known.
Cefotaxime has synergistic effects with aminoglycosides.
Dose recommendations:
Adults and adolescents over 12 years:
The usual dose in adults and adolescents is 1 g every 12 hours. However, dosage may be varied according to the severity of the infection, sensitivity of causative organisms and condition of the
patient.
Common infections in presence (or suspicion) of a sensitive pathogen: 1 g every 12 hours corresponding to a total daily dosage of 2 g
Infections in presence (or suspicion) of several sensitive or moderately sensitive pathogens: 1-2 g every 12 hours corresponding to a total daily dosage of 2-4 g.
Severe infection by unidentified pathogens or for infections that cannot be localised: 2-3 g as a single dose every 6 to 8 hours up to a maximum daily dosage of 12 g.
Infants and children (from 1 month up to 12 years of age):
The usual dosage for infants and children < 50 kg is 50-150 mg/kg/day divided into 2 to 4 doses.
In very severe infections up to 200 mg/kg/day divided into 2-4 doses may be required.
Neonates (0 to 27 days):
The recommended dosage is 50 mg/kg/day divided into 2 to 4 doses (every 12 to 6 hours).
In case of life-threatening situations it may be necessary to increase the daily dose to 150200 mg/kg/day taking the differences in maturation of the kidneys and renal function into account (please see also special dose recommendations for meningitis).
Premature infants:
The recommended dosage is 50 mg/kg/day divided into 2 to 4 doses (every 12 to 6 hours).
This maximum dose should not be exceeded due to the not yet fully matured kidneys and renal function.
Elderly:
No dosage adjustment is required, provided that the renal and hepatic functions are normal.
Other recommendations: gonorrhoea:
For gonorrhoea, a single injection Cefotaxime 0.5 g is administered (intramuscularly or intravenously). For complicated infections consideration should be given to available official guidelines. Syphilis should be excluded before initiating the treatment.
Acute meningitis:
Adults and adolescents over 12 years:
In adults daily doses of 6 to 12 g divided into equal doses every 6 to 8 hours are recommended.
In acute meningitis, the dose may be increased to 150-200 mg/kg bw/day, but rarely more than 3 g three times daily.
Infants and children (from 1 month up to 12 years of age):
150 to 200 mg/kg divided into equal doses every 6 to 8 hours.
Neonates:
In neonates 0-7 days old 50 mg/kg cefotaxime may be administered every 12 hours and in infants 8 -28 days old every 8 hours.
Intra-abdominal infections:
Cefotaxime should be used in combination with an antibiotic that is active against anaerobes in the treatment of intra-abdominal infections (please refer to section 5.1).
Duration of therapy:
The duration of therapy with Cefotaxime depends on the clinical condition of the patient and varies according to the cause of the disease. Administration of Cefotaxime should be continued until symptoms have subsided or evidence of bacterial eradication has been obtained. Treatment over at least 10 days is necessary in infections caused by Streptococcus pyogenes (parenteral therapy may be switched to an adequate oral therapy before the end of the 10 day period).
Impaired renal function:
In adult patients with a creatinine clearance of < 20 ml/min, the initial dose is similar to the recommended usual dose but the maintenance dose should be reduced by half without change in the frequency of dosing.
Dialysis or peritoneal dialysis:
In patients on haemodialysis and peritoneal dialysis an i.v. injection of 0.5-2 g, administered at the end of each dialysis session and repeated every 24 hours, is sufficient to treat most infections effectively.
Septicaemic infections:
In case of gram-negative pathogens a combination with another suitable antibiotic should be considered (please refer to section 5.1).
Method of administration:
Cefotaxime is administered by intravenous injection, intravenous infusion or intramuscular injection. The product is made into solution according to the instructions in the section 6.6.
The intramuscular method of administration is reserved to exceptional clinical situations and should undergo a risk-benefit assessment! It is recommended that no more than 4 ml is injected unilaterally. If the daily dose exceeds 2 g cefotaxime or if cefotaxime is injected more frequently than twice per day, the i.v. route is recommended. Intramuscular administration of cefotaxime reconstituted with lidocaine should not be administrated to children in the first year of age. The product information of the chosen lidocaine-containing medicinal product must be regarded.
In order to avoid any risk of infection, the reconstitution of the infusion should be done in close aseptic conditions. Do not postpone the infusion after the reconstitution of the solution.
Intravenous infusion:
For short intravenous infusion: Following reconstitution the solution should be administered as a 20 minute intravenous infusion.
For long lasting intravenous infusion: Following reconstitution, the solution should be administered as a 50-60 minutes intravenous infusion.
Intravenous injection:
For intravenous injection: Following reconstitution, the injection time should be 3-5 minutes. Intramuscular injection:
The solution should be administered by deep intramuscular injection. Solutions with lidocaine must not be administered intravenously. If the total daily dose is more than 2 g, the intravenous administration should be chosen. In case of severe infections, intramuscular injection is not recommended.
The following table shows the volume of dissolution for each vial size.
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Mode of ac |
ministration | |||
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Vial size |
Short intravenous infusion |
Long-lasting intravenous infusion |
Intravenous injection |
Intramuscular injection |
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500 mg |
- |
- |
2 ml |
2ml |
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1 g |
40-50 ml |
- |
4 ml |
4 ml |
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2 g |
40-50 ml |
100 ml |
10 ml |
- |
Preparation of solution for injection or infusion: Cefotaxime is compatible with:
Sodium chloride 0.9%; dextrose 5% or 10%, Ringer-lactate; lidocaine solution 1.0%.
- Aseptic techniques should be used to reconstitute the solution.
- The reconstituted solution should be administered immediately.
- Any unused solution should be discarded.
Intravenous infusion:
For short term intravenous infusion 1 g or 2 g Cefotaxime should be dissolved in 40-50 ml water for injections or in another compatible solution.
For long lasting intravenous infusion 2 g Cefotaxime should be dissolved in 100 ml of a suitable solution e.g. 0.9 % sodium chloride or isotonic glucose solution or other compatible solutions for infusions.
Preparation of an intravenous solution for infusion:
For the preparation of 2 g cefotaxime solution for infusion 1 vial of 50 ml Cefotaxime 2 g, a bottle of 100 ml sodium chloride 9 mg/ml (0.9%) solution for infusion and a sterile transfer device are needed. The transfer device will transfer or mix up of sterile liquids in closed system.
Step 1: Connect the transfer device with the bottle of sterile sodium chloride 9 mg/ml (0.9%) solution for infusion or other approved dilution system by spiking the device through the plastic cap of the bottle.
Step 2: Connect the other side of the device through the cap of the bottle with cefotaxime 2g powder for infusion.
Step 3: Mix up the isotonic solution with the powder of cefotaxime by shaking the vial system until all the powder is dissolved.
Step 4: Transfer all the solution into the 100 ml vial and disconnect the vial of cefotaxime from the transfer device.
Step 5: Connect a device for infusion to the spike on top of the 100 ml vial filled with dissolved cefotaxime and start infusion.
Intravenous injection:
Cefotaxime 0.5 g is dissolved in 2 ml water for injections or Cefotaxime 1 g is dissolved in 4 ml water for injections.
Intramuscular injection:
Cefotaxime 0.5 g is dissolved in 2 ml water for injections or Cefotaxime 1.0 g is dissolved in 4 ml water for injections.
In order to prevent pain caused by the injection, Cefotaxime 0.5 g may be dissolved in 2 ml 1% lidocaine hydrochloride or Cefotaxime 1 g may be dissolved in 4 ml 1% lidocaine hydrochloride (only for adults).
Following reconstitution the solution should be clear and pale yellow to brownish yellow. Do not use if any particulate matter is visible. For single use only.