INNOFIX 400 Hard Gelatin Capsules 400 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Cefixime Trihydrate Equivalent to Cefixime

Available from:

INNOVA CAPTAB LIMITED, INDIA

ATC code:

Third-generation Cephalosporins

INN (International Name):

Cefixime Trihydrate Equivalent to Cefixime

Dosage:

400 mg

Pharmaceutical form:

Hard Gelatin Capsules

Manufactured by:

INNOVA CAPTAB LIMITED, INDIA

Product summary:

Physical description: Purple/White colored "O" size telescopic cap and body hard gelatin capsule containing white to off white powder.; Local technical representative: GLOBAL DAR ES SALAAM PHARMACY LTD (5768)

Authorization status:

Registered/Compliant

Authorization date:

2022-01-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT
Cefixime Capsules 400mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains:
Cefixime USP (As Trihydrate)
Eq. to Cefixime anhydrous 400 mg
3. PHARMACEUTICAL FORM
Solid oral dosage form, Hard Gelatin Capsules
Purple / White coloured “0” size telescopic cap and body hard
gelatin capsule
containing white to off white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefixime is indicated in the treatment of the following infections
caused by
susceptible strains of the designated microorganisms:
UPPER RESPIRATORY TRACT:
Pharyngitis and tonsillitis caused by S. pyogenes.
MIDDLE EAR:
Otitis
media
caused
by
S.
pneumoniae,
H.
influenzae
(beta-lactamase
positive and negative strains), M. catarrhalis(former B. catarrhalis)
(beta-
lactamase positive and negative strains) and S. pyogenes.
PARANASAL SINUSES:
Sinusitis caused by S. pneumoniae, H. Influenza (beta-lactamase
positive
and
negative
strains),
and
M.
Catarrhalis
(former
B.
catarrhalis)
(beta-
lactamase positive and negative strains).
LOWER RESPIRATORY TRACT:
Acute
bronchitis
caused
by
S.
pneumoniae,
M.
Catarrhalis
(former
B.
catarrhalis) (beta lactamase positive and negative strains) and H.
influenzae (beta-
lactamase positive and negative strains).
URINARY TRACT:
Acute uncomplicated cystitis and urethritis caused by E. coli, P.
mirabilis, and
Klebsiella species.
UNCOMPLICATED GONORRHEA:
Uncomplicated gonorrhea (cervical/urethral and rectal) caused by
Neisseria
gonorrhoeae,
including
penicillinase
(beta-lactamase-positive)
and
non
penicillinase (beta- lactamasenegative) producing strains.
Appropriate cultures should be taken for susceptibility testing before
initiating
treatment with
Cefixime.
If
warranted,
therapy
may
be
instituted
before
susceptibility results are known; however, once these are obtained,
therapy
may need to be adjusted. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: the recommended dose of INNOFIX is 400 mg daily. This