País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
gentamicin sulfate, Quantity: 4.17 mg/mL (Equivalent: gentamicin, Qty 3 mg/mL)
B Braun Australia Pty Ltd
Injection, intravenous infusion
Excipient Ingredients: sodium chloride; water for injections; disodium edetate
Intravenous Infusion
20 bottles, 10 bottles
(S4) Prescription Only Medicine
For the treatment of infections due to one or more susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics). Gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. Aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. In suspected or documented Gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.
Visual Identification: A clear colourless aqueous solution, practically free from particles; Container Type: Bottle; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2019-05-17
B. BRAUN GENTAMICIN CMI- Version 2.0 Page 1 of 5 B. BRAUN GENTAMICIN INJECTION, INTRAVENOUS INFUSION Gentamicin _(jen-tah-mi-sin)_ CONSUMER MEDICINE INFORMATION _Date of Dispensing _ _Consumer Name _ _Pharmacist Name _ _Consumer Address _ _Pharmacist Address _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about B. BRAUN GENTAMICIN injection, intravenous infusion (gentamicin). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits . Your doctor has weighed the risks of you being given B. BRAUN GENTAMICIN injection, intravenous infusion against the benefits they expect it will have for you. This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE. You may need to read it again. WHAT B. BRAUN GENTAMICIN INJECTION, INTRAVENOUS INFUSION IS USED FOR Gentamicin is an antibiotic that belongs to a group of medicines called aminoglycosides (pronounced a-my-noe-GLY-koe-sides). It is used to treat serious bacterial infections. This medicine works by killing bacteria or preventing their growth. It is used for the treatment of serious infections, including: • septicaemia (infection of the blood) • respiratory tract infections • infected wounds • bone or tissue infections • infected burns • urinary tract infections. Your doctor may have prescribed gentamicin for another reason. Ask your doctor if you have any questions about why gentamicin has been prescribed for you. This medicine is available only with a doctor’s prescription. B. BRAUN GENTAMICIN CMI- Version 2.0 Page 2 of 5 BEFORE YOU ARE GIVEN B. BRAUN GENTAMICIN INJECTION, INTRAVENOUS INFUSION _WHEN YOU MUST NOT BE GIVEN IT _ YOU M Leer el documento completo
B. BRAUN GENTAMICIN PI – Version 2.0 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION – B. BRAUN GENTAMICIN (GENTAMICIN SULFATE) INJECTION 1. NAME OF THE MEDICINE Gentamicin Sulfate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION B. BRAUN GENTAMICIN 1 mg/mL injection, intravenous infusion Gentamicin (as sulfate) 1 mg/mL Sodium chloride 9 mg/mL Water for injections q.s. to 1 mL B. BRAUN GENTAMICIN 3 mg/mL injection, intravenous infusion Gentamicin (as sulfate) 3 mg/mL Disodium edetate 10 µg/mL Sodium chloride 9 mg/mL Water for injections q.s. to 1 Ml 3. PHARMACEUTICAL FORM Injection, intravenous infusion 4. CLINICAL PARTICULARS_ _ _4.1 _ THERAPEUTIC INDICATIONS_ _ For the treatment of infections due to one or more susceptible strains of bacteria, including _Pseudomonas aeruginosa_, Proteus species (indole positive and indole negative), _Escherichia _ _coli_, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics). Gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. Aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics. In suspected or documented Gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk of toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered. B. BRAUN GENTAMICIN PI – Version 2.0 Page 2 of 16 _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ For single use only. B Leer el documento completo