ZITHROMAX IV POWDER FOR SOLUTION FOR INFUSION 500 mgvial

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

AZITHROMYCIN (as AZITHROMYCIN DIHYDRATE)

Tilgængelig fra:

PFIZER PRIVATE LIMITED

ATC-kode:

J01FA10

Dosering:

100 mg/ml

Lægemiddelform:

INJECTION, POWDER, FOR SOLUTION

Sammensætning:

AZITHROMYCIN (as AZITHROMYCIN DIHYDRATE) 100 mg/ml

Indgivelsesvej:

INTRAVENOUS

Recept type:

Prescription Only

Fremstillet af:

Pharmacia & Upjohn Company LLC

Autorisation status:

ACTIVE

Autorisation dato:

2002-08-29

Indlægsseddel

Page 1 of 22 

ZITHROMAX 
(TABLETS, POWDER FOR ORAL SUSPENSION, POWDER FOR
INTRAVENOUS SOLUTION (IV)) 

1. 

NAME

OF

THE

MEDICINAL

PRODUCT 

ZITHROMAX
*
, ZITHROMAX

 IV. 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

POWDER  FOR  ORAL  SUSPENSION:  Azithromycin  dihydrate  209.64 mg/5 ml 
equivalent to 200 mg/5 ml of azithromycin base. 

FILM-COATED TABLET 250 MG: Azithromycin dihydrate 262.05 mg equivalent to 
250 mg azithromycin base. 

FILM-COATED TABLET 500 MG: Azithromycin dihydrate 524.10 mg equivalent to 
500 mg azithromycin base. 

FILM-COATED TABLET 600 MG: Azithromycin dihydrate 628.93 mg equivalent to 
600 mg azithromycin base. 

POWDER  FOR  INTRAVENOUS  SOLUTION  (IV):  Azithromycin  dihydrate  524.1  mg 
equivalent to 500 mg azithromycin base. 

3.  PHARMACEUTICAL FORM 

POWDER  FOR  ORAL  SUSPENSION:  Azithromycin  powder  for  oral  suspension  is 
presented  as  a  dry  powder  which  yields,  on  reconstitution  with  water,  an 
off-white to orange to brown suspension containing the equivalent of 200 mg 
azithromycin per 5 ml. 

FILM-COATED  TABLETS:  Azithromycin  film-coated  tablets  are  capsular  shaped 
and contain azithromycin dihydrate equivalent to 250 mg, 500 mg, or 600 mg 
of  azithromycin  and  engraved  with  either  “ZTM 250,”  “ZTM 500,”  or 
“ZTM 600”. 

INTRAVENOUS: Azithromycin is supplied in lyophilized form under a vacuum in a 
10  ml  vial  equivalent  to  500  mg  azithromycin  for  intravenous  administration. 
Upon  reconstitution,  azithromycin  powder  yields  a  solution  containing  the 
equivalent of 100 mg azithromycin per 1 ml. 

Page 2 of 22 

4.

CLINICAL

PARTICULARS 

Produktets egenskaber

ZITHROMAX
TABLETS, POWDER FOR ORAL SUSPENSION, POWDER FOR INTRAVENOUS (IV)
SOLUTION
1. NAME OF THE MEDICINAL PRODUCT
ZITHROMAX
*
, ZITHROMAX

IV.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION_ _
POWDER FOR ORAL SUSPENSION: Azithromycin dihydrate 209.64 mg/5 ml
equivalent to
200 mg/5 ml of azithromycin base.
FILM-COATED
TABLET
250 MG:
Azithromycin
dihydrate
262.05 mg
equivalent
to
250 mg azithromycin base.
FILM-COATED
TABLET
500 MG:
Azithromycin
dihydrate
524.10 mg
equivalent
to
500 mg azithromycin base.
FILM-COATED
TABLET
600 MG:
Azithromycin
dihydrate
628.93 mg
equivalent
to
600 mg azithromycin base.
POWDER FOR INTRAVENOUS (IV) SOLUTION: Azithromycin dihydrate 524.1 mg
equivalent
to 500 mg azithromycin base.
3. PHARMACEUTICAL FORM
POWDER
FOR
ORAL
SUSPENSION:
Azithromycin
powder
for
oral
suspension
is
presented as a dry powder, which yields, on reconstitution with water,
an off-white to
orange to brown suspension containing the equivalent of 200 mg
azithromycin per
5 ml.
FILM-COATED TABLETS: Azithromycin film-coated tablets are capsular
shaped and
contain
azithromycin
dihydrate
equivalent
to
250 mg,
500 mg,
or
600 mg
azithromycin.
POWDER FOR INTRAVENOUS SOLUTION: Azithromycin is supplied in a
lyophilized form
under
a
vacuum
in
a
10
ml
vial
equivalent
to
500
mg
azithromycin
for
IV
administration. Upon reconstitution, azithromycin powder yields a
solution containing
the equivalent of 100 mg azithromycin per 1 ml.
Not all presentations may be available locally.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for infections caused by susceptible
organisms; in lower
respiratory
tract
infections
including
bronchitis
and
pneumonia,
in
odontostomatological infections, in skin and soft tissue infections,
in acute otitis
media
and
in
upper
respiratory
tract
infections
including
sinusitis
and
pharyngitis/tonsillitis. (Penicillin is the usual drug of choice in
the treatment of
_Streptococcus pyogenes_ pharyngitis, including the prophylaxis of
rheumatic fever.
Azithromycin
is
generally
effective