VANCOMYCIN BNM vancomycin (as hydrochloride) 125 mg capsule blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

vancomycin hydrochloride, Quantity: 134 mg (Equivalent: vancomycin, Qty 125 mg)

MAH:

Boucher & Muir Pty Ltd

pharmaceutical_form:

Capsule, hard

composition:

Excipient Ingredients: macrogol 6000; titanium dioxide; ethanol; Shellac; Carnauba Wax; 1-butanol; glyceryl monooleate; brilliant blue FCF; maize starch; purified water; purified talc; Gelatin; sodium lauryl sulfate; tartrazine

administration_route:

Oral

units_in_package:

20

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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.

leaflet_short:

Visual Identification: Hard gelatin capsules size 2, with blue cap and yellow body, imprinted with OP64 on the cap and the body in white ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 12 Months; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Registered

authorization_date:

2022-08-31

PIL

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

SPC

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