Amikacin 10. Ampoules 250 mg. Ml. 2 ml
Amikacin 10. Ampoules 250 mg. / Ml. 2 ml
WHAT amikacin SOPHARMA AND WHAT IT IS USED
Amikacin belongs to the group of aminoglycoside antibiotics. Possesses pronounced antimicrobial action against gram-negative and a small portion of the gram-positive bacteria.
Sopharma amikacin injection / infusion is used for short-term treatment of serious infections, such as:
• Bacterial Septicemia (severe disease in which the causative agent is propagated in the blood and lymphatic system), including sepsis in neonates and endocarditis (inflammation of the endocardium of the heart caused by the bacteria).
• Infections of the central nervous system (including brain inflammation of skin).
• infections: respiratory system; bones and joints; skin and soft tissue; postoperative infections and after burning; infections in the abdominal cavity (including peritonitis); heavy, complicated and recurrent infections of the genitourinary system (originated in and uncomplicated infections from urinary amikacin applies only if the agent is not sensitive to antibiotics with low toxicity).
2. BEFORE YOU USE amikacin SOPHARMA
Do not use Amikacin Sopharma
• if you are allergic (hypersensitive) to the active substance amikacin or any of the other ingredients of the product.
• in case of hypersensitivity to other aminoglycosides.
Take special care with Amikacin Sopharma
Sopharma amikacin should be used with caution in the following cases:
• In patients with myasthenia (muscle weakness) or parkinsonism in hearing impaired and the equilibrium center, renal failure.
• In children due to immature renal function. Amikacin Sopharma not apply:
• When the microbial cause does not show sensitivity to it made in microbiology;
• In botulism.
Using 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. This is important because Amikacin Sofarma can alter the activity of certain drugs, or certain drugs may alter its effects. To avoid simultaneous administration of amikacin with other aminoglycoside antibiotics (gentamicin, kanamycin, streptomycin, tobramycin); antibiotics such as cephalosporins (cefazolin, cephalothin, cefaclor, cefoxitin, cefuroxime, cefotaxime, cefoperazone, etc..) polymyxins (colistin) and lincosamides (lincomycin), bacitracin; funds for drainage such as furosemide and ethacrynic acid; the anticancer drug cisplatin; amphotericin B (antifungal); peripheral muscle relaxants (means loosening the muscles); antibiotics such as tetracyclines, chloramphenicol; Botulinum toxin.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
During pregnancy, the use of Amikacin Sofarma should be avoided. During lactation is not recommended for use or only after careful consideration by the physician.
Driving and using machines
Testimony in which the Amikacin Sopharma exclude the possibility to drive and use machines.
Important information about some of the ingredients of Amikacin Sopharma
Contained as an excipient sodium metabisulphite may rarely cause severe hypersensitivity reactions and bronchospasm.
3. HOW TO USE amikacin SOPHARMA
Always use Sopharma Amikacin exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Sopharma amikacin administered only by persons with medical education.
Method of administration - intramuscular and intravenous.
Individual daily doses Amikacin Sopharma are the same for intramuscular and intravenous administration. Determine the weight of the patient. Before treatment with amikacin is necessary to evaluate renal function. Its performance was monitored periodically during treatment.
If you forget to use Amikacin Sopharma
Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amikacin Sopharma can cause side effects, although not everybody gets them. All aminoglycoside antibiotics can cause irreversible hearing impairment (these injuries occur initially with hearing loss only treble, dizziness and balance disorders); can have a toxic effect on the kidneys or cause neuromuscular block.
These conditions occur more frequently in patients with impaired renal function, concomitant treatment with other drugs that have a toxic effect on the kidneys and hearing; prolonged treatment with amikacin and / or administration of higher than recommended doses.
Other side effects - headache, change in sensitivity; inflammations of the mouth, nausea and vomiting, diarrhea; rash; changes in blood parameters: reducing the number of these cells: granulocytes, platelets, leukocytes; anemia (decreased numbers of red blood cells which can lead to pallor, weakness or dyspnea); occurrence of eosinophils in the blood, increased liver function tests such as bilirubin, transaminases and alkaline phosphatase; low blood pressure; swelling.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE amikacin SOPHARMA
Keep in the original container at a temperature below 25 ° C.
Do not freeze.
Keep out of reach of children.
Amikacin Sopharma not use after the expiry date stated on the carton. 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 does Amikacin Sopharma
• The active substance is amikatsinov sulfate equivalent to 250 mg of amikacin, or 500 mg in 2 ml of solution for injection / infusion, or 1, 000 mg in 4 ml of injection / infusion.
• The other ingredients are: sodium metabisulphite; sodium citrate; Sulphuric acid solution, 1 mol / l of water for injection.
Looks like Amikacin Sopharma and contents of the pack
Clear, colorless to pale yellow solution in 2 ml colorless glass ampoules, marked the opening of the ampoule colored dot or ring; 10 ampoules in blister PVC foil, 1 or 10 blisters in a carton with leaflet.
Clear, colorless to pale yellow solution in 4 ml colorless glass ampoules, marked the opening of the ampoule colored dot or ring; 10 ampoules in blister PVC film 1 or 5 blisters in a carton with leaflet.
Marketing Authorisation Holder and Manufacturer: Bulgaria
Method of administration - intramuscular and intravenous (spray or drip)
The individual daily dosages for amikacin are similar for intramuscular and intravenous administration. Before initiation of therapy with amikacin is necessary to assess the status of renal function to determine the endogenous creatinine clearance and serum concentrations. These indicators are monitored periodically during treatment.
Patients with normal renal function
Adults and children over 12 years
Adult and adolescent patients with normal renal function (creatinine clearance ? 50 ml / min) is recommended intramuscular or intravenous administration at a dose of 15 mg / kg per day, which can be administered as a single daily dose or divided into 2 equal doses, i.e. . 7.5 mg / kg every 12 hours.
The maximum daily dose should not exceed 1,5 g of patients with endocarditis and neutropenia with fever dosing should be twice a day, as there are insufficient data to support a single dose. Children 4 weeks to 12 years old.
In children aged 4 to 12 weeks of age with normal renal function is recommended intramuscular or intravenous (slow intravenous infusion) administration at a dose of 15-20 mg / kg per day, which can be administered once daily or 7.5 mg / kg every 12 hours.
In patients with endocarditis and neutropenia with fever dosing should be twice a day, as there are insufficient data to support a single dose.
Initially a loading dose of 10 mg / kg once daily, then continue treatment with a dose of 7.5 mg / kg every 12 hours (see sections 4.4 and 5.2).
7.5 mg / kg every 12 hours (see sections 4.4 and 5.2).
Specific recommendations for intravenous administration
Amikacin is not to be injected intravenously undiluted.
The infusion solution is prepared by 500 mg of the product was diluted with 200 ml of sterile 0.9% saline, or other compatible diluent (5% glucose, mannitol, Ringer's, or 6% dextran). Dose of 1, 000 mg is administered for 1 hour; dose of 500 mg - for 30 minutes or 1 hour.
Infusion for children and adults respectively continues 30-60 in infants - 1 to 2 hours.
In pediatric patients, the amount of solvent used is dependent on patient tolerance to amikacin.
Obese patients - the daily dose should not exceed 1.5 gr
Patients over 65 years of age
Initially assess kidney function. In dysfunction see Dosage in impaired renal function. Single daily dose is recommended for patients older than 65 years; in renal function; if the duration of the treatment for more than 10 days; for neutropenia; for infections caused by C (+)-microorganisms; infections caused by Pseudomonas and Serratia.
Uncomplicated urinary tract infections (except for those caused by Pseudomonas)
The product can be administered intramuscularly, or by intravenous infusion at a dose of 250 mg per 12 hours.
In infections caused by Pseudomonas - 500 mg or 750 mg every 8 hours. The course of the adult dose should not be higher than 15 g
Average duration of treatment - 7-10 days for intramuscular and intravenous 5-7 days.
Therapeutic effect in susceptible microorganisms is obtained 24 to 48 hours of application. In the event that, within 3 to 5 days no therapeutic efficacy, it is necessary to terminate treatment. In the presence of septic foci requiring surgical drainage or in a resistance to microorganisms as possible the infection is not affected.
If necessary, treatment can last more than 10 days (difficult to affect or complicated infections), assessing benefit / risk. Treatment after 10 days continues with monitoring of serum concentrations of amikacin, renal function, and auditory and vestibular apparatus.
Patient compliance with renal funkiiya (creatinine clearance <50 mL / min)
• It is not recommended once daily dosing.
• It is renal function be monitored and administered appropriate dose depending on her condition
• Dosage is determined in accordance with the values of creatinine clearance and serum creatinine level. Normal dose extended intervals of dosing
At steady state of the patient and unknown values of creatinine clearance interval between doses are calculated by multiplying the serum creatinine by 9 (t is the value of serum creatinine is 2 mg/100 mL, the recommended dose of 7.5 mg / kg should be administered at an interval of 18 hours).
Reduced dose of regular intervals between doses
Treatment was initiated at a dose of 7.5 mg / kg.