Ceftriaxone 1g Powder For Solution For Injection
CefTRIAXone 1g Powder for Solution for Injection CefTRIAXone 2g Powder for Solution for Injection or Infusion
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 or pharmacist.
- 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 or pharmacist. This includes any possible side effects not listed in this leaflet.
- The full name of this medicine is Ceftriaxone 1g Powder for Solution for Injection or Ceftriaxone 2g Powder for Solution for Injection or Infusion but within the leaflet they will be referred to as Ceftriaxone powder.
What is in this leaflet:
1. What Ceftriaxone powder is and what it is used for
2. What you need to know before you use
3. How to use
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. What Ceftriaxone powder is and what it is used for
Ceftriaxone is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotic are similar to penicillin.
Ceftriaxone kills bacteria and it can be used against various sorts of infections.
Like all antibiotics, ceftriaxone is only effective against some types of bacteria. Thus it is only suitable for treating some types of infection.
Ceftriaxone can be used to treat:
- infection of the membranes surrounding the brain and spinal cord (meningitis)
- infections of the lungs and breathing airways
2. What you need to know before you use Do not use Ceftriaxone powder
- if you are allergic (hypersensitive) to ceftriaxone, any of the other ingredients of Ceftriaxone powder or other cephalosporin antibiotics
- if you are allergic to any penicillin antibiotics
- for premature babies
- for newborn baby (up to 28 days) with jaundice (yellowing of the skin or eyes) or with blood problems or about to be given another injection that contains calcium
- by intramuscular injection
o in infants under 2 years of age and o during pregnancy and breast-feeding.
- you are allergic to lidocaine. You must not be given ceftriaxone as an injection into a muscle If you feel uncertain, ask your doctor or pharmacist.
Warnings and precautions Before your treatment starts, tell your nurse or doctor if you;
- if you have ever had an allergic reaction to any antibiotic,
- suffer from asthma or any other allergies
- have problems with both your liver and kidneys
- have ever had inflammation of your bowel, called colitis, or any other severe disease affecting your gut.
During or after treatment, make sure to tell your doctor or nurse immediately if you:
- get diarrhoea expecially if it is severe and contains blood
- get pain in the stomach area or chest (this may be a sign of inflammation of the gall bladder or pancreas)
- feel tired or look pale (this may be a sign of anaemia)
- think you have another infection started.
- you receive or are about to receive intravenous calcium. Please inform your doctor or nurse.
Ceftriaxone powder may also cause some laboratory tests to have an unusual result such as:
- the Coombs' test (a test done before a blood transfusion)
- tests for sugar in your urine (these may be done to test for diabetes).
Other medicines and Ceftriaxone powder Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are using:
- other antibiotics for treating infections like aminoglycosides
- the birth control pill (oral contraceptive). The “pill” may not work so you will need to take extra precautions such as condom or diaphragm during treatment with Ceftriaxone powder and in the month after treatment finalisation
- other medicines like probenecid used to treat gout.
- other antibiotics like chloramphenicol
- an anti-cancer medicine called amsacrine
- an anti-fungal medicine called fluconazole
- other antibiotic called vancomycin.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
- Are you pregnant, or do you think you might be pregnant? Although this medicine is not known to harm the unborn child, it should only be given to a pregnant woman if it is really necessary.
- Are you breast-feeding? This medicine should not be given to women who are breast-feeding. This is because a small amounts of it enter the milk and thus the breast-fed infant.
Driving and using machines
You may get dizzy when taking this medicine. This may affect your ability to drive or operate machinery. If this happens, do not drive or use machines.
Important information about some of the ingredients of Ceftriaxone powder
This medicinal product contains 3.6mmol (or 82.8mg) sodium per 1g vial or 7.2mmol sodium (165.6mg) sodium per 2g vial.
This should be taken into consideration for patients on controlled sodium diet.
3. How to use
Ceftriaxone is normally given by a doctor or nurse 1g vial
- It is given as an injection.
- The injection is given as a slow injection into a vein or a deep injection into a large muscle.
2g vial
- It is given as an injection or infusion.
- The injection is given as a slow injection into a vein or a deep injection into a large muscle.
- The infusion is given as a slow infusion into a vein.
The dose your doctor gives depends on the type of infection and how bad the infection is. It also depends on your weight and how your kidneys are working. Your doctor will explain this to you. The usual doses are:
Adults, older people and children 12 years and over who weigh more than 50kg
- 1 to 2g once a day
- In serious infections, this can be increased to 4g a day, injected into a vein.
Newborn babies (up to 14 days old)
- 20 to 50mg for each kg of body weight once a day, injected into a vein
- More than 50mg per kg must not be given, even in severe infections.
Children between 15 days and 12 years old
- 20 to 80mg for each kg of body weight once a day, injected into a vein
- More than 80mg per kg must not be given, even in severe infections - except in meningitis (infection
of the membranes surrounding the brain and spinal cord).
Special dose information:
- For infection of the membranes surrounding the brain and spinal cord (meningitis) at first 100mg per kg is given once a day (but no more than 4g a day). In newborn babies, no more than 50mg/kg must be given.
- For people with kidney problems, the dose does not need to be reduced, if liver function is normal. If the condition of the kidney is very poor (creatinine clearance of <10ml/min), the daily dose of ceftriaxone should not exceed 2g in adult patients.
- People with liver problems do not need the dose reducing unless they have kidney problems as well.
- If both kidney and liver function is severly impaired the blood ceftriaxone concentrations should be monitored regularly and the dosage adjusted appropriately for children and adults.
- If you are on dialysis, the doctor will do tests to make sure you are on the right dose.
Ceftriaxone is usually given once a day.
- The length of treatment is usually at least 2 days beyond the normalisation of body temperature
- It may continue for a total of 7 to 14 days.
If the patient is a child under 2 years old or a pregnant or breast-feeding woman, ceftriaxone should only be given by slow injection into a vein.
If you receive more Ceftriaxone powder than you should
A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.
If you forget to take Ceftriaxone powder
A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.
If you stop receiving Ceftriaxone powder
It is important to finish the course of treatment your doctor has prescribed, even if you start to feel better. If the treatment course is stopped too early the infection may start up again.
If you do not feel well at the end of the prescribed treatment course or even feel worse during treatment you should talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects happen, stop taking this medicine and tell your doctor immediately or go to your nearest hospital accident and emergency department.
Following side effects are rare (affect less than 1 in 1,000 people):
- allergic reactions such as sudden wheeziness and tightness of the chest, swelling of the eyelids, face or lips, severe skin rashes that can blister and may involve the eyes, mouth and throat and genitals, loss of consciousness (fainting).
Following side effects are very rare (affect less than 1 out of 10,000 people):
- diarrhoea that is serious, lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation (called “pseudomembranous colitis”) that can happen after taking antibiotics.
Very common side effects (affects more than 1 user in 10):
• gall stones in children
Common side effects (affects 1 to 10 users in 100):
• drops in the numbers of white blood cells (sometimes severe with increased risk of severe infection)
• a type of anaemia that can be severe and is caused by red blood cells breaking up. If you are having a blood test for any reason, tell the person who is taking your blood sample that you are taking this medicine as it may affect your result.
• reduced number of blood platelets (increase chance of bleeding and bruising)
• nausea, vomiting, diarrhoea, sores, inflammation of the tongue
• allergic reactions (skin rash, itching, nettle rash, swellings of the skin and joints)
• changes in blood tests that check how your liver is working
• pain and hardness when injected into a muscle
• pain and redness when injected into a vein
Uncommon side effects (affects 1 to 10 users in 1,000):
• • stomach pain, loss of appetite
• headache, dizziness
• infections: Having a course of ceftriaxone can temporarily increase the chance that you can get infections caused by other bacteria (germs). For example, thrush may occur
• the passage of very little urine or other kidney problems
Rare side effects (affects 1 to 10 users in 10,000):
• severe cramps in the belly (caused by inflammation of the pancreas)
• gall stones in adults
• • kidney stones in children
• blood or sugar in your urine.
• fever and shivering
Very rare side effects (affects less than 1 user in 10,000):
• reduced white blood cells (increased chance of infection)
• anemia
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions.
Keep the vial(s) in the outer carton in order to protect from light.
Opened and after reconstitution:
Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and 24 hours at 2 to 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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, unless reconstitution has taken place in controlled and validated aseptic conditions.
The reconstituted solution is light yellow to amber coloured, clear solution.
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.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
6. Contents of the pack and other information What Ceftriaxone powder contains
- The active substance is ceftriaxone sodium equivalent to either 1g or 2g ceftriaxone.
- There are no other ingredients.
What Ceftriaxone powder looks like and contents of the pack
Almost white or yellowish, slightly hygroscopic crystalline powder.
1g powder for solution for injection:
20ml vials of clear type I glass closed with grey siliconated, bromobutyl rubber stopper with blue coloured flip-off seal.
2g powder for solution for injection or infusion
20ml and 100ml vials of clear type I glass closed with grey siliconated, bromobutyl rubber stopper with white coloured flip-off seal.
Pack sizes: Packs of 20ml and 100ml vials: 1, 2, 4 and 5 vials Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78 IS-220 Hafnarfjordur Iceland
Manufacturers
Actavis Nordic A/S 0rnegardsvej 16 2820 Gentofte Denmark
Actavis Group PTC ehf. Reykjavikuvegi 76-78 IS-220 Hafnarfjordur Iceland
This leaflet was last revised in July 2013
The following information is intended for healthcare professionals only: CefTRIAXone 1g Powder for Solution for Injection CefTRIAXone 2g Powder for Solution for Injection or Infusion
Instructions for use and handling
When reconstituted for intramuscular or intravenous injection (1g or 2g) or infusion (2g only), the almost white or yellowish, slightly hygroscopic crystalline powder gives a clear, pale yellow to amber solution.
Reconstituted solutions should be inspected visually. Only clear solutions free of visible particles should be used. The reconstituted product is for single use only and any unused solution must be discarded.
Ceftriaxone should not be mixed in the same syringe with any medicinal product other than 1% lidocaine hydrochloride solution (for intramuscular injection only).
Intravenous injection
Ceftriaxone 1g powder for solution for injection should be dissolved in 10ml water for injections.
Ceftriaxone 2g powder for solution for injection/infusion should be dissolved in 20ml of water for injections. The injection should be administered over at least 2 to 4 minutes directly into the vein.
Intravenous infusion
Ceftriaxone 2g powder for solution for injection/infusion should be dissolved in 40ml of one of the following calcium-free infusion solutions: Sodium chloride 0.9%, sodium chloride 0.45% and glucose 2.5%, glucose 5% or 10%, dextran 6% in glucose 5%, hydroxyethyl starch 6-10% infusions. See also section Incompatibilities below.
The infusion should be administered immediately as a short time infusion over at least 30 minutes. Intramuscular injection
Ceftriaxone 1g powder for solution for injection should be dissolved in 3.5ml of 1% lidocaine hydrochloride injection solution.
Ceftriaxone 2g powder for solution for injection/infusion should be dissolved in 7.2ml of 1% lidocaine hydrochloride injection solution.
The solution should be administered by deep intramuscular injection. Doses greater than 1g ceftriaxone should be divided and injected on more than one site.
Solutions in lidocaine should not be administered intravenously.
Incompatibilites
Ceftriaxone must never be mixed with any of the following solutions:
- solutions containing calcium such as Hartmann's and Ringer's solutions because percipitation can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions.
- aminoglycosides (when given concurrently, these preparations must be administered separately)
- Ceftriaxone must not be administered in the same syringe as other antibiotics or other bactericidal agents.
- A chemical intolerance of ceftriaxone has also been reported with amsacrine (antitumour agent), vancomycin (antibiotic) and fluconazole (fungicide).
Dosage
Dosage and mode of administration should be determined by the severity and site of infection, susceptibility of the causative micro-organism and the patient’s age and condition. Information on normal dosage is in the Summary of Product Characteristics.
Shelf-life - Opened and after reconstitution
Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and 24 hours at 2 to 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
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