LINEZOD Film Coated Tablet 600mg

দেশ: তাঞ্জানিয়া

ভাষা: ইংরেজি

সূত্র: Tanzania Medicinces & Medical Devices Authority

সক্রিয় উপাদান:

Linezolid Tablets 600 mg

থেকে পাওয়া:

Lincoln Pharmaceuticals Limited, INDIA

এটিসি কোড:

Other antibacterial drugs

INN (আন্তর্জাতিক নাম):

Linezolid Tablets 600 mg

ডোজ:

600mg

ফার্মাসিউটিকাল ফর্ম:

Film Coated Tablet

Manufactured by:

Lincoln Pharmaceuticals Limited, INDIA

পণ্য সারাংশ:

Physical description: White to off white coloured, capsule shaped, biconvex, plain on both sides of film coated tablet; Local technical representative: Heko Pharmacy Limited (7718)

অনুমোদন অবস্থা:

Registered/Compliant

অনুমোদন তারিখ:

2022-09-21

পণ্য বৈশিষ্ট্য

SUMMARY OF THE PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
Linezolid Tablets 600 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE DECLARATION
Linezolid USP QUANTITATIVE DECLARATION For full list of Excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Dosage Form, Tablets
White to off-white coloured, capsule shaped, biconvex, plain on both
sides of film coated
tablets.
Distribution Category: POM
4.
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Nosocomial pneumonia, Community acquired pneumonia: It is indicated in
adults for the
treatment of community acquired pneumonia and nosocomial pneumonia
when known or
suspected to be caused by susceptible Gram positive bacteria. In
determining whether
Linezolid is an appropriate treatment, the results of microbiological
tests or information on
the prevalence of resistance to antibacterial agents among Gram
positive bacteria should
be taken into consideration. It is not active against infections
caused by gram negative
pathogens.
Specific
therapy
against
Gram
negative
organisms
must
be
initiated
concomitantly if a gram negative pathogen is documented or suspected.
complicated skin
and soft tissue infections.
Linezolid is indicated in adults for the treatment of complicated skin
and soft tissue infections
only when microbiological testing has established that the infection
is known to be caused
by susceptible gram positive bacteria.
It is not active against infections caused by gram negative pathogens.
Linezolid should only
be used in patients with complicated skin and soft tissue infections
with known or possible
co-infection with Gram negative organisms if there are no alternative
treatment options
available in these circumstances treatment against gram negative
organisms must be
initiated concomitantly.
Linezolid should only be initiated in a hospital environment and after
consultation with a
relevant specialist such as a microbiologist or infectious diseases
specialist.
Consideration should be given to official guidance on the appropria