Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
vancomycin hydrochloride, Quantity: 268 mg (Equivalent: vancomycin, Qty 250 mg)
Boucher & Muir Pty Ltd
Capsule, hard
Excipient Ingredients: macrogol 6000; titanium dioxide; brilliant blue FCF; maize starch; purified water; purified talc; iron oxide yellow; Gelatin; sodium lauryl sulfate; ethanol; Shellac; Carnauba Wax; 1-butanol; glyceryl monooleate
Oral
20
(S4) Prescription Only Medicine
Vancomycin BNM capsules may be administered orally for the treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis produced by C. difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore Vancomycin BNM must be given orally. Vancomycin BNM is not effective by the oral route for other types of infection.
Visual Identification: Hard gelatin capsules size 0, with blue cap and dark-yellow body, imprinted with OP65 on the cap and the body in white ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 15 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2022-08-31
Vancomycin BNM 1 VANCOMYCIN BNM 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 TAKING VANCOMYCIN BNM? Vancomycin BNM contains the active ingredient vancomycin hydrochloride. Vancomycin BNM is used to treat infections involving the bowel. For more information, see Section 1. Why am I taking Vancomycin BNM? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE VANCOMYCIN BNM? Do not take if you have ever had an allergic reaction to Vancomycin or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS SUCH AS PRE-EXISTING HEARING LOSS OR A SPECIAL SENSORY IMPAIRMENT (E.G. BLINDNESS), KIDNEY OR LIVER DISEASE, 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 take Vancomycin BNM? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Vancomycin BNM 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 TAKE VANCOMYCIN BNM? • Follow the instructions provided when Vancomycin BNM was prescribed, including the number of days it should be taken. More instructions can be found in Section 4. How do I take Vancomycin BNM? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING VANCOMYCIN BNM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking Vancomycin BNM. • Tell your doctor if the symptoms of your infection do not improve within a few days or if they become worse. • Tell your doctor if you become pregnant while taking Vancomycin BNM capsules. THINGS YOU SHOULD NOT DO • Do not stop taking this medicine suddenly. • Do not take Vancomycin BNM capsules to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if read_full_document
VANCOMYCIN BNM 1 AUSTRALIAN PRODUCT INFORMATION VANCOMYCIN BNM (VANCOMYCIN HYDROCHLORIDE) CAPSULES This preparation for the treatment of colitis is for oral use only. Vancomycin BNM must be given orally for treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis produced by _Clostridioides difficile_ . If parenteral vancomycin therapy is desired, use suitable sterile vancomycin products available from other brands, and consult accompanying Product Information document. Parenteral administration of vancomycin is not effective for treatment of staphylococcal enterocolitis and antibiotic- associated pseudomembranous colitis produced by _Clostridioides _ _difficile_ ; therefore, vancomycin hydrochloride must be given orally for these indications. Orally administered Vancomycin BNM is not effective for other types of infections. 1 NAME OF THE MEDICINE Vancomycin hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vancomycin BNM capsules contain either 125 mg or 250 mg of vancomycin (as hydrochloride) as the active ingredient. Excipient(s) with known effect: tartrazine (125 mg capsules only). It may contain sulfites. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Vancomycin BNM 125 mg capsules are size 2, hard gelatin capsules, with blue cap and yellow body, imprinted with “OP64” on the cap and the body in white ink. Vancomycin BNM 250 mg capsules are size 0, hard gelatin capsules, with blue cap and dark-yellow body, imprinted with “OP65” on the cap and the body in white ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vancomycin BNM capsules may be administered orally for the treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis produced by _C. difficile_ . Parenteral administration of vancomycin is not effective for the above indications; therefore, VANCOMYCIN BNM 2 Vancomycin BNM must be given orally. Vancomycin BNM is not effective by the oral route for other types of infection read_full_document