Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
linezolid, Quantity: 600 mg
Cipla Australia Pty Ltd
Linezolid
Tablet, film coated
Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; hyprolose; microcrystalline cellulose; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000
Oral
10, 30
(S4) Prescription Only Medicine
LINEZOLID CA is indicated for the treatment of suspected or proven infections due to Gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant Staphylococcus species and vancomycin resistant Enterococcus species.,LINEZOLID CA is active against Gram-positive bacteria only. ,LINEZOLID CA has no clinical activity against Gram-negative pathogens. Specific Gram-negative therapy is required if a concomitant Gram- negative pathogen is documented or suspected.
Visual Identification: White to off-white, oval shaped, biconvex, film-coated tablets, debossed on one side "CL".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-01-24
LINEZOLID CA* 1 LINEZOLID CA* CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING LINEZOLID CA? LINEZOLID CA contains the active ingredient linezolid. LINEZOLID CA is used to treat bacterial infections such as pneumonia, skin infections or blood infections. For more information, see Section 1. Why am I using LINEZOLID CA? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE LINEZOLID CA? Do not use if you have ever had an allergic reaction to linezolid or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use LINEZOLID CA? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LINEZOLID CA and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE LINEZOLID CA? • The recommended dose for adults and adolescents 12 years and older is one 600 mg tablet twice daily (every 12 hours). More instructions can be found in Section 4. How do I use LINEZOLID CA? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING LINEZOLID CA? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist that you are taking LINEZOLID CA. • It is important to tell the doctor if you develop diarrhea, sore white mouth or tongue during or after treatment with LINEZOLID CA. • Tell the doctor if you or your child get vaginal itching or discharge. THINGS YOU SHOULD NOT DO • Do not start taking any other medicines, prescription or not, without first telling your doctor or pharmacist. • Do not give your child any other medicines, prescription or purchased from a health food shop, pharmacy or supermarket without first telling your doctor or pharmacist. DRIVING OR USING MACHI Lees het volledige document
AUST R 272902 AUST R 272901 Page 1 of 23 Cipla Australia PRODUCT INFORMATION LINEZOLID CA 600MG FILM-COATED TABLETS NAME OF THE MEDICINE Non-proprietary name: Linezolid Chemical name: (5 _S)-N_ -[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5- oxazolidinyl]methyl]-acetamide The empirical formula of linezolid is C 16 H 20 FN 3 O 4 and its chemical structure is represented below: CAS Number: CAS-165800-03-3 DESCRIPTION LINEZOLID CA tablets contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class with a molecular weight of 337.35. Linezolid is biologically active and is metabolised to form inactive derivatives. The aqueous solubility of linezolid is approximately 3 mg/mL, independent of pH between pH 3 to 9 and is sparingly soluble in methanol and soluble in chloroform. The partition coefficient (Log P) is 0.61 and pKa is 1.8. LINEZOLID CA exhibits polymorphism (form II). LINEZOLID CA 600 mg tablets for oral administration are white to off-white, oval shaped, biconvex, film-coated tablets, debossed on one side “CL”. In addition to linezolid, the tablets contain, in the core, cellulose-microcrystalline, starch-pregelatinised maize, sodium starch glycollate type A, hyprolose, magnesium stearate and, in the film coating, Opadry II complete film coating system 85F28751 White (Proprietary Ingredient # 10277). AUST R 272902 AUST R 272901 Page 2 of 23 Cipla Australia PHARMACOLOGY PHARMACODYNAMICS _GENERAL PROPERTIES_ Linezolid is a synthetic, antibacterial agent belonging to a new class of antibiotics, the oxazolidinones, with _in vitro _ activity against Gram positive aerobic bacteria, some Gram positive anaerobic bacteria and certain Gram negative bacteria. It selectively inhibits bacterial protein synthesis via a mechanism of action different from that of other antibacterial agents. Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome and prevents the formation of a functional 70S initiation complex which is an essential component of the bacterial transla Lees het volledige document