KLACID IV FOR INJECTION 500 mgvial

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

CLARITHROMYCIN

Saadav alates:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC kood:

J01FA09

Annus:

500 mg/vial

Ravimvorm:

INJECTION, POWDER, FOR SOLUTION

Koostis:

CLARITHROMYCIN 500 mg/vial

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

Prescription Only

Valmistatud:

DELPHARM SAINT REMY

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

1997-01-06

Infovoldik

I.V.

1. NAME OF THE MEDICINAL PRODUCT 
Clarithromycin 500 mg, Powder
for Intravenous Solution for Injection (IV) 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
One vial contains 500 mg of clarithromycin. 

For the full list
of excipients, see PHARMACEUTICAL PARTICULARS, LIST OF
EXCIPIENTS. 

3. PHARMACEUTICAL FORM 
FORMULATION PHARMACEUTICAL 
FORM 
Clarithromycin 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:  
1.  Upper respiratory tract infections 
2.  Lower respiratory tract infections 
3.  Skin and soft tissue infections 
4.  Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium 
intracellulare. Localized infections due to Mycobacterium
chelonae, Mycobacterium fortuitum, or 
Mycobacterium kansasii. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
DOSAGE AND ADMINISTRATION 
Intravenous therapy may be given for 2 to 5 days and should
be changed to oral clarithromycin therapy when 
appropriate.  Klacid IV
should be administered into one of the larger proximal
veins as an IV infusion over 60 
minutes using a solution concentration of about
2 mg/ml. Clarithromycin should be given as a bolus or an 
intramuscular injection. 

ADULTS: The recommended dosage of Klacid IV in adults 18 years
of age or older is 1.0 g daily divided into two 
500 mg doses, appropriately diluted as described below. 
PEDIATRIC: There are insufficient data to recommend a
dosage regimen for use of the Klacid IV formulation in 
patients less than 18 years of age (see Pediatric Suspension). 
ELDERLY: As for adults. 

_RENAL IMPAIRMENT  _
In patients with re

Toote omadused

I.V.
1. NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500 mg, Powder for Intravenous Solution for Injection
(IV)*
* This product may be supplied with Water for Injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 500 mg of clarithromycin.
For the full list of excipients, see PHARMACEUTICAL PARTICULARS, List
of excipients.
3. PHARMACEUTICAL FORM
Formulation
Pharmaceutical Form
Clarithromycin 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
adults 18 years and older in the following conditions:
1.
Upper respiratory tract infections
2.
Lower respiratory tract infections (see section 4.4 and 5.1 regarding
Sensitivity Testing)
3.
Skin and soft tissue infections (see section 4.4 and 5.1 regarding
Sensitivity Testing)
4.
Disseminated or localized mycobacterial infections due to
Mycobacterium avium or Mycobacterium
intracellulare. Localized infections due to Mycobacterium chelonae,
Mycobacterium fortuitum, or
Mycobacterium kansasii.
Consideration should be given to national official guidance on the
appropriate use of antibacterial
agents.
4.2 Posology and method of administration
Dosage and Administration
Intravenous therapy may be given for 2 to 5 days and should be changed
to oral clarithromycin therapy when
appropriate. Klacid
®
IV should be administered into one of the larger proximal veins as an
IV infusion over 60
minutes using a solution concentration of about 2 mg/ml.
Clarithromycin should be given as a bolus or an
intramuscular injection.
Adults: The recommended dosage of Klacid
®
IV in adults 18 years of age or older is 1.0 g daily divided into two
500 mg doses, appropriately diluted as described below.
Pediatric: There are insufficient data to recommend a dosage regimen
for use of the Klacid
®
IV formulation in
patients less than 18 years of age (see Pediatric Suspension).
Elderly: As for adults.
Renal Impairment
In patients wi