Vansafe-CP 1000 Powder for solution for injection 1000 mg

Country: Tansanía

Tungumál: enska

Heimild: Tanzania Medicinces & Medical Devices Authority

Virkt innihaldsefni:

vancomycin Hydrochloride

Fáanlegur frá:

VHB MEDI SCIENCES LIMITED, INDIA

ATC númer:

Other antibacterial drugs

INN (Alþjóðlegt nafn):

vancomycin Hydrochloride

Skammtar:

1000 mg

Lyfjaform:

Powder for solution for injection

Framleitt af:

,

Vörulýsing:

Physical description: White almost white or tan to brown, free flowing powder; Local technical representative: GENERICS & SPECIALITIES LIMITED

Leyfisstaða:

Registered/Compliant

Leyfisdagur:

2021-10-09

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
VANSAFE-CP 1g (Vancomycin Hydrochloride for Injection USP)
ANATOMIC THERAPEUTIC CHEMICAL CLASSIFICATION AND DISTRIBUTION CATEGORY
ATC Classification: J01X01, Anti-bacterial Agent
Distribution category: Prescription only drug
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains:
Vancomycin Hydrochloride USP
Equivalent to Vancomycin……………….1g
3.
PHARMACEUTICAL FORM DOSAGE FORM: DRY Powder for Injection DESCRIPTION: White to almost white or tan to brown free flowing
powder
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vancomycin is indicated for the treatment of serious or severe
infections caused by susceptible
strains
of
methicillin-resistant
(beta-lactam-resistant)
staphylococci.
It
is
indicated
for
penicillinallergic patients, or in those who have failed to respond to
other medicines, including
the
penicillins
or
cephalosporins,
and
for
infections
caused
by
vancomycin
-susceptible
organisms that are resistant to other antimicrobial medicines.
Vancomycin is indicated as an
initial
therapy
when
methicillin-resistant
staphylococci
are
suspected.
However,
when
the
susceptibility data is available, therapy should be adjusted
accordingly.
Vancomycin is effective in the treatment of Staphylococcal
endocarditis. Effectiveness has also
been
documented
in
other
infections
due
to
staphylococci,
including
septicaemia,
bone
infections, lower respiratory tract infections, and skin and
skin-structure infections. When
staphylococcal infections are localized and purulent, is recommended
that the antibiotics be
used as adjuncts to appropriate surgical measures.
Vancomycin is reported to be effective alone or in combination with an
aminoglycoside for
endocarditis caused by S. viridans or S. bovis. For endocarditis
caused by enterococci (e.g.,
Enterococcus faecalis), vancomycin has been reported to be effective
only in combination with
an aminoglycoside.
Vancomycin has been reported to be effective for the treatment of
diphtheroid endocar