Klacid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clarithromycin 25 mg/mL;  ;  

Available from:

Viatris Limited

INN (International Name):

Clarithromycin 25 mg/mL

Dosage:

125 mg/5mL

Pharmaceutical form:

Granules for oral suspension

Composition:

Active: Clarithromycin 25 mg/mL     Excipient: Carbomer Castor oil Citric acid monohydrate Fruit mix flavour WL-18758 204264 Hydrated silica Hypromellose phthalate Maltodextrin Potassium sorbate Povidone Sucrose Titanium dioxide Xanthan gum

Units in package:

Bottle, plastic, 70 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Zhejiang Guobang Pharmaceutical Co., Ltd

Therapeutic indications:

Klacid Suspension is indicated for treatment of infections caused by susceptible organisms. Such infections include: ? Upper respiratory infections (e.g. streptococcal pharyngitis). ? Lower respiratory infections (e.g. bronchitis, pneumonia). ? Acute otitis media. ? Skin and skin structure infections (e.g. impetigo, folliculitis, cellulitis, abscesses). ? Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localised infections due to Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, - 70 mL - 60 months from date of manufacture stored at or below 30°C 14 days reconstituted stored at or below 30°C 36 months from date of manufacture stored at or below 25°C. product manufactured at AbbVie Srl - Bottle, plastic, - 100 mL - 60 months from date of manufacture stored at or below 30°C 14 days reconstituted stored at or below 30°C 36 months from date of manufacture stored at or below 25°C. product manufactured at AbbVie Srl

Authorization date:

1993-03-10

Summary of Product characteristics

Page 1 of 33
NEW ZEALAND DATA SHEET
KLACID
®
, KLACID
® IV
1. PRODUCT NAME
Klacid, 250 mg and 500 mg, film coated tablet.
Klacid, 125 mg/5 mL and 250 mg/5 mL, granules for oral suspension.
Klacid IV, 500 mg, powder for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Klacid 250 mg: Each film coated tablet contains 250 mg of
clarithromycin.
Klacid 500 mg: Each film coated tablet contains 500 mg of
clarithromycin.
Klacid 125 mg/5 ml: Each 5 ml of the granules for suspension contains
125 mg of clarithromycin.
Klacid 250 mg/5 ml: Each 5 ml of the granules for suspension contains
250 mg of clarithromycin.
Klacid IV: Each vial contains 739.5 mg clarithromycin lactobionate,
corresponding to 500 mg of
clarithromycin.
For the full list of excipients, see section 6.1.
Klacid Suspension: Contains sugars and sorbates.
Klacid Tablet: Contains sorbates
3. PHARMACEUTICAL FORM
Klacid 250 mg – yellow, ovaloid, film coated tablets.
Klacid 500 mg – pale yellow, ovaloid, film coated tablets.
Klacid 125 mg/5 ml: white to off-white granules.
Klacid 250 mg/5 ml: white to off-white granules.
Klacid IV: white to off-white caked, lyophilized powder.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Klacid
I.V.
is
indicated
whenever
parenteral
therapy
is
required
for
treatment
of
sensitive
microorganisms in the following conditions:
Page 2 of 33

Upper respiratory tract infections.

Lower respiratory tract infections (see section 4.4 and 5.1 regarding
Sensitivity testing).

Skin and soft tissue infections (see section 4.4 and 5.1 regarding
Sensitivity testing).
Klacid Suspension is indicated for treatment of infections caused by
susceptible organisms. Such
infections include:

Upper respiratory infections (e.g. streptococcal pharyngitis).

Lower respiratory infections (e.g. bronchitis, pneumonia) (see section
4.4 and 5.1 regarding
Sensitivity testing).

Acute otitis media.

Skin and skin structure infections (e.g. impetigo, folliculitis,
cellulitis, abscesses) (see section
4.4 and 5.1 regarding Sensi