Gentamicin 80 mg. 2 ml. 5 ampules

SANDOZ
Gentamicin 80 mg. 2 ml. 5 ampules
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Active substance:
Each ampoule contains Gentamicin Sulphate in the form of Gentamicin 40 mg / 2 ml or 80mg / 2rnl.Lekarstvena form: 1,6,10,50,100 ampoules i.tn. / iv
Pharmacotherapeutic group:
antibacterial
Indications: For the treatment of infections caused by organisms susceptible to Gentamicin.
In pleuropulmonary forms: bronchitis manifest bronhopneumoniya pulmonary pneumoniya, pleurisy, empyema; acute and chronic urinary tract infections, cystitis, pyelitis, cystopyelitis, pyelonephritis, infective lithiasis (pelvis, ureter, bladder), urethritis, prostatitis, vesiculitis; under septic conditions: bacteremia, septicemia, septic pyaemia, neonatal sepsis; infections of the nervous system, meningitis, meningoencephalitis, etc .; in surgical infections: abscesses, phlegmon. osteomyelitis, traumatic infections; in otorinolaringologicheski infections: suppurative otitis media, sinusitis, mastoiditis, tonzilitis, faringotonzilitis; in gynecological infections, septic abortion, metritis, parametritis, sappingitis, salpingo-ovaritis, pelvic peritonitis, mastitis, etc .; burns, infections caused by burns and skin transplants together with formulations for topical use.
In infections caused by suspected or proven gram-negative microorganisms, Gentamicin can be regarded as the drug of choice. In severe infections, life-threatening patient, Gentamicin may be administered in combination with beta-lactam antibiotics (carbenicillin or similar agents in infections caused by Pseudomonas aeruginosa, and antibiotics of the penicillin type in endocarditis caused by streptococci of group D).
 
Contraindications:
Hypersensitivity to Gentamicin and other components. The toxic effects of aminoglycosides using antibiotic can be considered as a contraindication. Significant renal failure and decreased function of the hearing (also contraindications). Gentamicin is usually contraindicated during pregnancy and lactation.
Precautions:
During treatment, patients should drink plenty of fluids. The test of renal function is particularly important during treatment with Gentamicin and other aminoglycosides, especially in elderly patients, this function can be reduced. In these patients it is advisable to control the creatinine clearance. Similar precautions are recommended for severe infections associated with the use of a special high-dose treatment period longer than recommended. In elderly patients and children, who experience a syndrome Fanconi, is accompanied by metabolic and aminoaciduria acidosis.Po during treatment with aminoglycosides is advisable to determine the serum levels in order to avoid a reduction or exceeding of the doses. In the case where there is a peak at a concentration of gentamicin above 12 mcg / ml, lasts longer and a minimum level before the next injection (over 2 mcg / ml), if necessary, can be avoided by diluting the acceptance or reducing the dose.
In case of renal failure, the dose and the injection interval has to be selected according to the creatininemia, which depends on the degree of renal impairment. It should be taken in the case of combination with flucytosine, diuretics, and methoxyflurane. As with all antibiotics, Gentamicin treatment could lead to overdevelopment of sensitive organisms. In such cases, treatment should be discontinued and appropriate therapy initiated.
Interactions with other medications and forms of interaction
Among the aminoglycoside observed cross-allergic reactions. Increasing the potential renal toxicity of Gentamicin is observed following co-administration or - which should be avoided - other potential neurotoxic agents such as: cisplatin, polymyxin B, colistin, viomycin, streptomycin, vancomycin, aminoglycosides and certain other cephalosporins (such as cephaloridine) or potent diuretics such as ethacrynic acid and furosemide.Ednovremennoto acceptance (even local) other potentially nephrotoxic and ototoxic antibiotics could increase the risk of these efekti.Vapreki that, in clinical practice is not reported blockade when using Gentamicin or other aminoglycosides, this reaction is likely to occur especially when taken with Gentamicin succinylchline or tubocurarin either during massive transfusions of citrated blood. In this case, the blockage may be removed by adopting the calcium salt. In-vitro combination of aminoglycosides with beta-lactam antibiotic (penicillin or cephalosporin) could cause mutual and significant inefficiencies. Even when an aminoglycoside antibiotic and penicillin-like antibiotic was adopted by two different routes, a reduction in half-life and plasma levels of aminoglycosides occurs in patients with renal insufficiency, and in some patients with normal renal activity. Reducing the half-life of Gentamicin plasma was observed in patients with severe renal insufficiency treated concomitantly with carbenicillin. Typically, inactivation of the aminoglycoside antibiotic is important only in patients with severe renal insufficiency.
warnings:
Gentamicin Injection and other aminoglycosides, is potentially nefrotoksik: nephrotoxicity usually occurs as ototoxicity, as a violation of the vestibular and auditory functions. The risk of nephrotoxicity is greater in patients with impaired renal function and in those taking large doses or late lechenieto.Produktat contains sodium bisulphite, which could cause allergic-type reactions or asthma pristap.Upotreba and dosages: Gentamicin may is administered intramuscularly or intravenously. Doses were ednakvi.Intravenozniyat manner recommended in cases where intramuscular administration is impossible (the patients in a state of shock, when bleeding in haematological disorders, severe burns or reduced muscle mass in myeloproliferative forms). Intravenous administration should be carried out preferably by infusion over 1-2 h. At the same doses and to identify and separate prilozhenie.Vsyaka intramuscular dose should be dissolved in 100-200 ml of saline or 5% distroza; for children the amount of the solvent may be reduced. In some cases, the concentration of Gentamicin need not exceed 1 mg / ml (0.1%). Gentamicin can also be injected intravenously undiluted (this method, however, could be used in exceptional cases). Other routes of administration are carried out clinical trials on the use of Gentamicin as intrarahidalno and intraventricular administration (adults 4-8 mg daily for children 1 -2 mg daily).
 
DO NOT MIX WITH OTHER PRODUCT drugs in the same syringe.
A) Patients with normal renal function c:
Adults: the dose for treating systemic infections is 3 mg / kg per day (1 mg / kg every 8 h. Or 1.5 mg / kg every 12 hours.) In infections, life-threatening patient, it is recommended that the dose is 5 mg / kg daily, administered 3-4 doses for the first 2-3 days of treatment and then be reduced to 3 mg / kg dnevno.Za urinary and extra-urinary infections moderate, 2m / kg daily, of 2 separate doses would be dostatachno.Obichaynata dose for patients weighing more than 50 kg shall be determined as follows: 1 ampoule Gentamicin 80 mg / ml 2 - 3 times a day at systemic infektsii1 ampoule Gentamicin80 mg / 2 ml - 2 times a day for urinary and extra -urinarni infections vumerena degree
 
Practical: Newborn (3.5-5 kg): 0.5 ml of Gentamicin 40mg / 2ml every 12 hours. Children 5-10 kg:% amp. of Gentamicin 40 mg / 2 ml every 8-12 hours. Children 11 to 20 kg: 1 amp. of Gentamicin 40 mg / 2 ml every 8-12 ch.Dozisnoto adjustment must be in accordance with the age of the patient, type and severity of infektsiyata.Pri obese patients the dosage should be calculated on the basis of their theoretical weight. The duration of treatment typically lasts for 7 to 10 days. In the case of more severe infections requires a longer treatment period. It is recommended to continue the treatment over a no-no less than 48 hours after the normalizing temperature. B) Patients with reduced renal function.
 
 
 
 
 
 
Frequency of approximately acceptance could be calculated as follows: mg / 100 ml of serum creatinine x 8 = interval between two successive received (hours) .HemodializaPri adult patients with renal failure undergoing hemodialysis, the amount of Gentamicin, purified from blood plasma depends on various factors, among which the dialysis method. 6-hour hemodialysis may reduce the level of Gentamicin in the plasma of 50%. Recommended doses after sessions ranged from 1 to 1.7 mg / kg, depending on the severity of the infection. For children, doses of 2 to 2.5 mg / kg.
Aminoglycoside antibiotics were purified from the blood plasma in the peritoneal dialysis, but to a lesser degree than hemodializata.Predozirane: If predozirane.v consequence of wrong dosage, if necessary, the peritoneal dialysis and hemodialysis are useful methods for removal of Gentamicin kravta.Nezhelatelni efektiPri patient with decreased renal activity or treated with doses of Gentamicin, no-larger than prescribed, kidney disorders with protenuria and changes in tests of renal function.
Side effects were seen in vestibular and auditory system VIII pair of cranial nerves, mainly in patients with renal impairment and in patients undergoing long-term treatment and / or higher doses. Symptoms include tinnitus, vertigo and reduced hearing sensitivity. The reduction in hearing sensitivity may be a first indication to reduce the severity of the hearing loss and can be irreversible tip.Podobno other aminoglycosides, vestibular changes may be irreversible. Other factors that could increase the risk of ototoxicity include: dehydration, concomitant diuretics such as ethacrynic acid and furosemide or prior acceptance of other ototoxic compounds. Symptoms are the following: apathy, paresthesias, fasciculations, seizures syndrome similar to myasthenia gravis. Other side effects can be identified: a decrease in respiratory function, visual disturbances, anorexia, weight loss, fluctuations in blood pressure, skin rashes of various types, anaphylactic manifestations, fever, headache, vomiting, stomatitis, temporary hepatomegaly. There have also been changes in laboratory parameters, which include: increased levels of transaminases (AST, ALT) and lactic dehydrogenase (LDH), alkaline phosphatase and bilirubin, reducing the level of calcium, magnesium, potassium and sodium, anemia, leukopeniya, granulocytopenia, transient agranulocytosis, eosinophilia, increase or decrease in reticulocytes, тромбоцитопения.Обикновено injection is well tolerated. Sometimes, however, injection site pain is felt and there is a subcutaneous atrophy or signs of local irritation.
Storage
Keep in places with a temperature of not higher than 25 C.
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