VANCOMYCIN MYLAN 500 MG

देश: इसराइल

भाषा: अंग्रेज़ी

स्रोत: Ministry of Health

सक्रिय संघटक:

VANCOMYCIN AS HYDROCHLORIDE

थमां उपलब्ध:

GENMEDIX , ISRAEL

ए.टी.सी कोड:

A07AA09

फार्मास्यूटिकल फॉर्म:

LYOPHILIZED POWDER FOR CONCENTRATED SOLUTION

रचना:

VANCOMYCIN AS HYDROCHLORIDE 500 MG/VIAL

प्रशासन का मार्ग:

I.V, ORAL

प्रिस्क्रिप्शन प्रकार:

Required

द्वारा बनाया गया:

MYLAN S.A.S., FRANCE

चिकित्सीय समूह:

VANCOMYCIN

चिकित्सीय क्षेत्र:

VANCOMYCIN

चिकित्सीय संकेत:

Vancomycin hydrochloride is indicated for the treatment of severe or serious infections due to susceptible strains of methicillin - resistant (beta-Iactam-resistant) staphylococci. It is also indicated for administration to penicillin-allergic patients as well patients who have failed to respond to or who cannot receive other drugs including cephalosporins or penicillins and for infections due to vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride is indicated for first-line therapy when methicillin-resistant staphylococci are suspected but when susceptibility data become available appropriate therapy should be instituted. Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis as well as in other infections due to staphylococci including lower respiratory tract infections septicemia skin and skin - stucture infection and bone infections. Antibiotic therapy is as an adjunct to appropriate surgical measures when sta

प्राधिकरण की तारीख:

2011-10-31

सूचना पत्रक

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה ךיראת
/2017
3
/
8
םושירה רפסמו תילגנאב רישכתה םש
30297
-
63
-
123
–
VANCOMYCIN MYLAN 500 MG
30298
-
64
-
123
–
VANCOMYCIN MYLAN 1 G
םושירה לעב םש :
GENMEDIX
! דבלב תורמחהה טורפל דעוימ הז ספוט
ה
תושקובמה תורמחה
ןולעב קרפ טסקט
שדח טסקט
יחכונ
4.1
THERAPEUTIC
INDICATIONS
…
Oral THERAPY administration:
Vancomycin hydrochloride injection may be given orally for the
treatment of antibiotic- associated Pseudomembrannous colitis due
to Staphylococcus enterocolitis and Clostridium difficile.
Vancomycin hydrochloride is not effective orally when
administered for other types of infection.
Vancomycin is ineffective in these diseases if given parenterally
…
Oral Therapy Vancomycin hydrochloride injection may be given orally
for the treatment of antibiotic-associated Pseudomembrannous colitis
due to Staphylococcus enterocolitis and Clostridium difficile.
Vancomycin hydrochloride is not effective orally when administered
for other types of infection.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.4 SPECIAL
WARNINGS
AND
PRECAUTIONS
FOR USE
...
Nephrotoxicity:Some patients with inflammatory disorders of the
intestinal mucosa may have significant systemic absorption of oral
vancomycin must be used with cautionand, therefore, may be at
risk for the development of adverse reactions associated with the
parenteral administration of vancomycin. The risk is greater in
patients with renal failure asimpairment. It should be noted that the
possibilitytotal systemic and renal clearances of developing toxic
effects is much highervancomycin are reduced in the
…
Nephrotoxicity: vancomycin must be used with caution in patients with
renal failure as the possibility of developing toxic effects is much
higher in the presence of prolonged high blood concentrations. In the
treatment of these patients and in t

उत्पाद विशेषताएं

Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vancomycin Viatris 500 mg
Vancomycin Viatris 1000 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vancomycin 500 mg lyophilized powder for concentrated solution.
Each vial contains 500 mg vancomycin (as hydrochloride), equivalent to
500,000 IU.
When reconstituted with 10 ml of water for injections, the solution
contains 50mg/ml vancomycin.
Vancomycin 1000 mg lyophilized powder for concentrated solution.
Each vial contains 1 g vancomycin (as hydrochloride), equivalent to
1,000,000 IU.
When reconstituted with 20 ml of water for injections, the solution
contains 50mg/ml vancomycin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilized powder for concentrated solution for intravenous infusion
or for oral solution.
White or almost white freeze dried powder.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
INTRAVENOUS INFUSION
Vancomycin hydrochloride is indicated for the treatment of severe or
serious infections due to
susceptible strains of methicillin - resistant (beta-Iactam-resistant)
staphylococci.
It is also indicated for administration to penicillin-allergic
patients as well patients who have failed to
respond to or who cannot receive other drugs including cephalosporins
or penicillins and for infections
due to vancomycin-susceptible organisms that are resistant to other
antimicrobial drugs.
Vancomycin hydrochloride is indicated for first-line therapy when
methicillin-resistant staphylococci are
suspected but when susceptibility data become available appropriate
therapy should be instituted.
Vancomycin hydrochloride is effective in the treatment of
staphylococcal endocarditis as well as in
other infections due to staphylococci including lower respiratory
tract infections septicemia skin and
skin - structure infection and bone infections.
Antibiotic therapy is as an adjunct to appropriate surgical measures
when staphylococcal infections
are purulent and localized.
Page 2 of 15
For endocarditis due to