Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
amikacin, Quantity: 500 mg
Pfizer Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium citrate dihydrate; water for injections; sodium metabisulfite
Intravenous, Intramuscular
5 x 2mL vials
(S4) Prescription Only Medicine
DBL Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria, (see section 5.1 Pharmacodynamic properties).,Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin.,The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of staphylococcus who have failed to respond or are allergic to other available antibiotics.,DBL Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.,In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in-vitro mixing of the two drugs causes inactivation of amikacin.,Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intraabdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.
Visual Identification: A clear colourless to pale yellow solution free from visible particulate matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1994-09-01
DBL™ AMIKACIN INJECTION _amikacin_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DBL Amikacin Injection. 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 Amikacin Injection against the benefits they expect it will have for you. 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 DBL AMIKACIN INJECTION IS USED FOR Amikacin 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. Amikacin works by killing bacteria or preventing their growth. Your doctor may have prescribed amikacin for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AMIKACIN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN DBL AMIKACIN INJECTION _WHEN YOU MUST NOT BE GIVEN_ _IT_ YOU MUST NOT BE GIVEN DBL AMIKACIN INJECTION IF YOU HAVE AN ALLERGY TO AMIKACIN OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: • shortness of breath, wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN DBL AMIKACIN INJECTION IF YOU HAVE EXPERIENCED SERIOUS REACTIONS (SUCH AS HEARING LOSS OR KIDNEY PROBLEMS) TO AMIKACIN, STREPTOMYCIN, GENTAMICIN, TOBRAMYCIN, KANAMYCIN, POLYMYXIN B, COLISTIN, CEFALORADINE, VIOMYCIN, OR NEOMYCIN IN THE PAST. YOU MUST NOT BE GIVEN DBL AMIKACIN INJECTION IF YOU HAVE MYASTHENIA GRAVIS, A CONDITION IN WHICH THE MUSCLES BECOME WEAK AND TIRE EASILY. YOU MUST NOT BE GIVEN AMIKACIN IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT. Amikacin may affect your developing baby Lue koko asiakirja
Version pfpamiki10522 Superscedes: pfpamiki11121 Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION – DBL ™ AMIKACIN INJECTION (AMIKACIN) 1. NAME OF THE MEDICINE Amikacin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Amikacin Injection is available in 500 mg/2 mL strength. Each 2 mL contains amikacin sulfate equivalent to amikacin activity 500 mg (500,000 IU). EXCIPIENT WITH KNOWN EFFECT • Sulfites For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. DBL Amikacin Injection is a sterile clear, colourless to pale yellow solution free from visible particulate matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria, (see section 5.1 Pharmacodynamic properties). _Staphylococcus aureus,_ including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin. The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics. DBL Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used. In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because _in-vitro_ Version pfpamiki10522 Superscedes: pfpamiki11121 Page 2 of 17 mixing of the two drugs causes inactivation of amikacin. Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal se Lue koko asiakirja