MEDAXONE 1 g. 10 vials
MEDAXONE 1 g. 10 vials
MEDAXONE WHAT IS AND WHAT IT IS USED FOR?
The name of your medicine is MEDAXONE. Ceftriaxone belongs to the group of medicines known as cephalosporin antibiotics. It is indicated for the treatment of bacterial infections caused by susceptible microorganisms by destroying or inhibiting the growth of bacteria. Treat many kinds of infections of the skin and soft tissues, bones, joints, blood (septicemia), respiratory tract infection (pneumonia). Ceftriaxone also treats some sexually transmitted diseases (gonorrhea). It can also be used to treat other infections such as meningitis. It can also be used to helps prevent the occurrence of infections occurring in high risk patients. MEDAXONE may be made prior to surgery to reduce the incidence of postoperative infections. Your doctor will tell you what kind of infection you are being treated and will tell more.
2 BEFORE YOU TAKE MEDAXONE
Do not take MEDAXONE
- If you are allergic (hypersensitive) to ceftriaxone or other medicines containing antibiotics such as penicillins or cephalosporins.
Ceftriaxone is contraindicated in:
• Premature adjusted under the age of 41 weeks (gestational age + weeks of life);
• Infants (up to 28 days after birth) with:
- Or jaundice which have hiloalbuminemiya or acidosis, as these are the conditions under which it is likely to be impaired binding of bilirubin.
If they need to (or is expected to need) by intravenous treatment with calcium or calcium-containing fluids due to the risk of ceftriaxone-calcium precipitates.
Take special care with MEDAXONE
• If you have had a severe allergic reaction to cephalosporin antibiotics or any other medicines, especially penicillins
• If you have kidney problems
• If you are pregnant, trying to become pregnant or breast-feeding
• If you have liver problems or those with biliary tract
• If you have a history of gastrointestinal disease (especially colitis)
• If you have diabetes.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is important to tell your doctor if you use:
• Aminoglycoside antibiotics
• Diuretics (used to enhance urination)
• Hormonal contraceptives
If you make certain laboratory tests (Coombs test, urinalysis), please inform your doctor that you are taking MEDAXONE.
In some cases, your doctor will order additional monitoring, but it is routine and should not worry you.
You should tell your doctor or pharmacist if you have recently received or get calcium.
Taking MEDAXONE with food and drink
During treatment with MEDAXONE should avoid the use of alcohol. Pregnancy and lactation
If you are pregnant or trying to become pregnant, ask your doctor or pharmacist before taking any medicine, including MEDAXONE. Not recommended for use during pregnancy.
Since ceftriaxone is found in breast milk is not recommended for use during breastfeeding.
Driving and using machines
Before driving or operating machinery should check how your therapy affects MEDAXONE.
Important information about some of the ingredients of MEDAXONE
Each gram of ceftriaxone contains approximately 3,6 mmol sodium. This must be taken into account when high-dose treatment of patients who have a restricted diet of sodium.
3 HOW TO APPLY MEDAXONE?
Always use MEDAXONE exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. If possible, always read the patient information before starting treatment.
This medicine will always be done by a doctor or nurse. This is because it must be done in the form of an injection. This medicine will be made or as an injection into a vein (intravenously) or into a muscle (intramuscular). Your doctor, nurse or pharmacist will have to mix the powder with water for injection or other compatible solution, and to prepare it for injection into a muscle or vein. The product should not be added to a solution containing calcium. Your doctor will decide how much you need per day and how often you need to do the injection. Usually depends on the severity of the disease.
Adults and children over 12 years:
The usual dose for the treatment of infections in adults is 1 g, administered as a single daily dose intramuscularly. In severe infections, the dosage can be increased to typically 2 to 4 g, administered as a single dose every 24 hours. Treatment usually lasts for two days after symptoms disappear or temperature.
• Gonorrhea (acute uncomplicated): Intramuscular administration of a single dose of 250 mg.
• Perioperative prophylaxis: It is usually given as a single 1 g of intramuscular injection or by slow intravenous route.
• Prevention of meningococcal meningitis: Intramuscular administration of a single dose of 250 mg.
Not require dose adjustment in the elderly, unless available hepatic and renal failure.
The recommended daily dose is between 20 and 50 mg / kg MEDAXONE. The maximum dose should not exceed 50 mg / kg. If used by the intravenous route, the dose should be given time over 60 minutes.
Children aged 6 weeks to 12 years:
The recommended daily dose MEDAXONE is 25-50 mg / kg / day, given as a single daily dose. In severe infections may be administered dose up to 80 mg / kg / day as a single daily dose. Doses of 50mg / kg or higher should be administered by slow intravenous infusion lasting at least 30 minutes.
Prevention of meningococcal meningitis: Intramuscular administration of a single dose of 125 mg.
No dose adjustment is required if it is not available and renal impairment
Not require dose adjustment in mild to moderate renal insufficiency, if not available, and liver failure. In the case of severe renal impairment, creatinine clearance less than 10 ml / min, the daily dose should be limited to 2 g or less.
Liver failure with renal insufficiency:
At regular intervals should be determined plasma concentrations of ceftriaxone and, if necessary, the dose can be adjusted.
Following dialysis, no additional dose. Since the rate of elimination can be varied in these patients should be monitored in plasma concentrations in order to determine if any dose adjustments
If you take more than you should MEDAXONE
It is unlikely that you will be given more medicine nurse or doctor. Your doctor and nurse will monitor your recovery and check the drug, which will be applied. If you are not sure why you are being given a dose of medication, always consult with them.
If you forget to use MEDAXONE
Your doctor or nurse will have instructions on when you apply the medicine. Less likely to not be given this medicine in the way appointed. If you think you may have missed a dose, then talk to your nurse or doctor.
Do not take two doses at the same time to make up the missed dose.
If you stop applications MEDAXONE
It is important to complete assignments by your doctor course. It is possible to feel better, but it is important not to stop this medicine unless your doctor advises otherwise your condition may get worse again.
If you have any further questions relating to use of this medicine, ask your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, MEDAXONE can sometimes cause side effects, although not everybody gets them. The most common side effects were diarrhea, nausea and vomiting. Other reported side effects include allergic skin and anaphylactic reactions, fungal infections or changes in blood counts.
Common side effects (more than 1 out of 100, but less than 1 out of 10):
• Loose stools or diarrhea
Uncommon side effects (more than 1 out of 1000, but less than 1 in 100):
• Allergic skin reactions: maculopapular rash, exanthema, urticaria, dermatitis, itching, swelling
Rare side effects (more than 1 in 10,000 but less than 1 in 1000):
• Sponges genital tract
• Neutropenia, leukopenia, eozinopeniya, thrombocytopenia, anemia (low blood count)
• Bronchospasm (tightening of the airways)
• Headache, dizziness
• Stomatitis (inflammation of the mouth), glossitis (inflammation of the tongue)
• oliguria (reduced amount of urine), hematuria (blood in urine), glucosuria (sugar in urine)
• Phlebitis (inflammation of the vein), and pain at the injection site
Very rare (less than 1 in 10,000 patients) side effects include:
• Abnormal blood clotting
• colitis (inflammatory bowel disease), pancreatitis (inflammation of the pancreas)
• Toxic epidermal necrolysis.
Rare, severe and sometimes fatal side effects in premature infants and infants (less than 28 days) who were treated with ceftriaxone and calcium intravenously. At autopsy, the lungs and the kidneys were observed precipitates of calcium salts of ceftriaxone. The increased risk of precipitation in the newborn due to their low blood volume and the extended life of ceftriaxone, compared with that in adults
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
Do not worry about these possible effects. Many people have no side effect of ceftriaxone.
5 HOW TO STORE MEDAXONE?
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Keep the vials in the outer carton to protect from light.
6 FURTHER INFORMATION:
- The active substance is ceftriaxone (iceftriaxone) as ceftriaxone sodium (ceftriaxone sodium).
MEDAXONE 1 g powder for solution for injection contains 1 g of ceftriaxone as ceftriaxone sodium.
- Excipients: contains.
MEDAXONE looks like and contents of the pack?
Supplied in colorless glass vial type I, with a nominal volume of 10 ml, closed with a rubber stopper with a diameter of 20 mm and an aluminum seal. Packs with 1,10,50 or 100 vials.
Not all pack sizes may be marketed.