Gentamicin 40 mg. 1 ml. 10 ampoules
Gentamicin Sofarma injection contains active substance gentamicin, which relates to antimicrobial drugs aminoglycoside. Possesses antimicrobial activity against a large number of agents of different infections. Gentamicin Sofarma injection is used to treat serious infections such as bacterial sepsis (a disease in which the bacteria multiply in the blood and lymphatic system), endocarditis; infections of the central nervous system infection in patients with suppressed immune system or in tumors; infections in burn; kidney infections and / or urinary tract infections, ear-nose-throat infections, infections of the respiratory system; of the sexual organs of the abdominal cavity (incl. gall and bile duct); infections of skin and soft tissues, bones and joints; brucellosis felinoza (cat scratch disease), inguinal granuloma, listeriosis, salmonellosis, shigellosis.
Apply for prevention of endocarditis, surgical infections in patients with compromised immune protection and intensive care patients.
2. What you need to know before you start treatment with Gentamicin Sopharma?
Do not use Gentamicin Sopharma
If you are allergic to gentamicin, aminoglycosides (there is cross-hypersensitivity to antibiotics of this class) or any of the other ingredients of this medicine (listed in section 6).
- If you have severe renal insufficiency;
- If you have disorders of the auditory nerve;
- When botulism
- If you are pregnant.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before using Gentamicin Sopharma.
Tell your doctor if you have any chronic disease, hypersensitivity to drugs or food, or taking other medicines you are surgery.
It is gentamicin be used with caution in the following cases:
- In patients suffering from myasthenia (muscle weakness) or parkinsonism in hearing disorders and equilibrium center, in patients with impaired renal function in elderly patients (over 65 years), dehydration, cystic fibrosis, obesity.
In order to avoid the occurrence of adverse events is recommended continuous monitoring of renal function (before, during and after treatment with gentamicin) by testing of urine (creatinine clearance and serum concentration of creatine), to control the functions of the auditory and vestibular system ( connected with the balance) and study of liver and laboratory parameters.
Children and adolescents
In neonates and premature infants and in infants after the first month, have strict and careful dosing.
Other medicines and Gentamicin Sopharma
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
Before starting the introduction of gentamicin, tell the doctor if you are taking the following medications: other aminoglycoside antibiotics (amikacin, kanamycin, streptomycin, tobramycin; polymyxins (colistin) and lincosamides (lincomycin), bacitracin, agents used for drainage as furosemide and ethacrynic acid; antitumor drug cisplatin, amphotericin B - antifungal agents, curare-like drugs, antibiotics, such as tetracycline, chloramphenicol, antibiotic cephalosporin such as cephalexin, cefazolin, cephalothin, cefaclor, etc .; anti-inflammatory drug indomethacin, due to an increased risk of renal impairment.
Gentamicin enhances the effect of botulinum toxin, and therefore should avoid using it in botulism.
If you are taking narcotic drugs and / or analgesics, tell your doctor due to the risk of respiratory depression when taken together with gentamicin.
Gentamicin Sopharma with food, drinks and alcohol
During treatment with gentamicin was necessary to take a sufficient amount of liquid.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
If you are pregnant, you should not apply Gentamicin Sopharma due to the risk of hearing damage in the fetus, in some cases to complete irreversible deafness.
In the period of lactation is not recommended the use of gentamicin or given only after careful consideration by the doctor. The occurrence of adverse reactions in nursing infants, the mother should stop breastfeeding.
Driving and using machines
During treatment with Gentamicin Sopharma is necessary to avoid driving or operating machinery, and activities requiring caution because of the risk of experiencing dizziness, tinnitus, loss of balance.
Gentamicin Sopharma contains sodium sulphite, which in rare cases can cause severe hypersensitivity reactions and bronchospasm. Increased sensitivity to sulphites is observed more frequently in asthmatics.
Gentamitsnn Sopharma contain parahydroxybenzoates, which can cause allergic reactions (possibly delayed) and exceptionally, bronchospasm. Gentamicin Sofarma containing sodium, less than 1 mmol (23 mg) per dose, ie contains virtually no sodium.
3. How to use Gentamicin Sopharma?
The dose and duration of treatment is determined by the physician according to the age, weight of the patient, the severity of the infection and the functional condition of the organism. Gentamicin administered only by persons with medical education.
Individual daily doses of gentamicin are the same for intramuscular and intravenous administration. Before starting treatment with gentamicin is necessary to assess renal function. Its performance monitored periodically during treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you use more than the amount of Gentamicin Sopharma
If the dose you have been given, was more than the amount of Gentamicin Sopharma can be seen none effects of overdose.
Immediately tell your doctor if during the treatment experience nausea, vomiting, dizziness, impaired neuromuscular impaired breathing.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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 to treble, dizziness and impaired balance); can have a toxic effect on the kidneys or cause neuromuscular block. These disorders occur more frequently in patients with impaired renal function; concomitant treatment with other drugs that have toxic effects on hearing and kidneys; prolonged treatment with gentamicin and / or administration of higher than recommended doses.
Very common (affects more than 1 in 10 patients): hearing loss, vertigo, tinnitus, impaired renal function (usually reversible). Common (affects less than 1 in 10 patients): swelling.
Not honor (affects less than 1 in 100 patients): inflammation of the mouth, nausea and vomiting, diarrhea; transient increases in liver function tests such as bilirubin, transaminases, alkaline phosphatase.
Rare (affects less than 1 in 1000 patients): changes in blood parameters - reducing the number of these blood cells, granulocytes, platelets, leukocytes, anemia; occurrence of eosinophils in the blood; decreases in potassium, calcium, magnesium.
Very rare (affects less than 1 in 10,000 patients): hypersensitivity reactions with hives, skin rash, itching; hypersensitivity reactions in asthmatics because of the presence of sulphite in the product; hypersensitivity reactions because of hydroxybenzoates in the product; kidney failure.
Not known (from the available data can not be estimated). After administration of gentamicin may occur neurotoxicity with peripheral nerve damage and manifestation of symptoms of central nervous system such as confusion, lethargy (apathy and lethargy), hallucinations, convulsions, depression, headache, change in sensation (tingling); low blood pressure; edema; violations of breathing and muscle blockade; atrophy and necrosis at the site of application. It is possible that the development of disseminated infections due to microorganisms resistant to gentamicin and fungi - more frequently during long term treatment.
If you get any side effects, tell your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet.
5. How to store Gentamicin Sopharma?
Store in the original package in order to protect from light. Do not store above 25 ° C. Do not freeze!
Keep out of the reach and sight of children.
Sopharma gentamicin should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
The active substance is gentamicin sulfate, eq. 40 mg of gentamicin in 1 ml solution for injection or 80 mg in 2 ml of solution for injection.
The other ingredients are: methyl parahidroksibsnzoat (E218); propylparahydroxybenzoate (E216); edetate disodium; sodium sulfite anhydrous (E221); sulfuric acid solution (1 mol / l); water for injections.
Looks like Gentamicin Sopharma and contents of the pack?
Colorless to pale yellow solution.
Colorless glass ampoules first hydrolytic class, with a capacity of I nil or 2 ml, to mark the opening of the vial - colored dot / ring.
10 ampoules in PVC foil, 1 or 10 blisters in a cardboard box together with a leaflet. IIc all pack sizes may be marketed.