Spersadex comp eye drops

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

DEXAMETHASONE SODIUM, PHOSPHATE, CHLORAMPHENICOL

Beszerezhető a:

Laboratoires THEA 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France

ATC-kód:

S01CA01

INN (nemzetközi neve):

DEXAMETHASONE SODIUM PHOSPHATE 1 mg/ml CHLORAMPHENICOL 5 mg/ml

Gyógyszerészeti forma:

EYE DROPS, SOLUTION

Összetétel:

DEXAMETHASONE SODIUM PHOSPHATE 1 mg/ml CHLORAMPHENICOL 5 mg/ml

Recept típusa:

POM

Terápiás terület:

OPHTHALMOLOGICALS

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2006-01-30

Betegtájékoztató

Spersadex_MT_8144_5_23253900   27.12.2005  9:49 Uhr  Seite 1 

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Spersadex
® 
comp. Eye Drops

(Dexamethasone, Chloramphenicol)

Read all of this leaflet
carefully before you start using  this 
medicine

•  Keep this leaflet. You may need to read it again.

•  If you
have further questions,  please ask your doctor or pharmacist.

•  This medicine has been
prescribed  for you personally and you should not 
pass  it on  to others. It may harm them, even if
their symptoms  are the 
same as yours.

•  The active ingredients   are  dexamethasone
  sodium phosphate

1mg/ml and chloramphenicol 5.5mg/ml.

•  The other ingredients are benzalkonium
chloride,  dilute hydrochloric acid, 
disodium edetate,  macrogol  400,  polyoxyl castor oil, water for injections.

Marketing Authorisation  Holder: 

Laboratoires THEA 
12 rue Louis Blériot 
63017 Clermont-Ferrand Cedex 2 
FRANCE 

Manufacturer: 
Excelvision AG, 
Riethofstrasse 1,

CH-8442 Hettlingen, 
Switzerland

1. What Spersadex
®  
comp. Eye Drops is and what it is used for The 
name of  your  eye  drops  is  Spersadex
®  
comp. The  active ingredients  
are 5.5mg chloramphenicol   and 1mg  d

Termékjellemzők

SPERSADEX
®
 COMP 

(CHLORAMPHENICOL, DEXAMETHASONE SODIUM PHOSPHATE) 

SUMMARY OF PRODUCT CHARACTERISTICS 

Number of pages: 
5 

Laboratoires THEA 

                   Page 2 
Summary of Product Characteristics                  

Spersadex comp. Eye Drops 

1. 
  NAME OF THE MEDICINAL PRODUCT 
Spersadex
®
 comp

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Chloramphenicol 5.5mg/ml 
Dexamethasone sodium phosphate 1.0mg/ml 
For excipients, see 6.1. 
3. 
  PHARMACEUTICAL FORM 
Eye Drops, Solution 
4. CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Spersadex comp®  Eye Drops is used in acute and chronic keratitis 
and conjunctivitis of an 
infectious, allergic but non-viral nature, infections of the
anteriour uvea (iritis, iridocyclitis), 
skleritis, episcleritis and myositis, sympathic ophthalmia,
post-operative management of cataract, 
glaucoma and strabismus. 
4.2 
  POSOLOGY AND METHOD OF ADMINISTRATION 
1 drop 3-5 times daily. In severe cases up to 1 drop every hour. 
The duration of treatment should not be more than 10 days. 
Paediatric use: Studies in the paediatric population have not been
performed. Due to the 
possibility of adverse systemic effects, caution is required when
administering the product to 
infants (28 days to 3 months old), and to children under 2 years age
(see section 4.4). Spersadex 
comp must not be used in newborn infants (0 to 27 days old) (see
section 4.3).  
4.3 
 CONTRAINDICATIONS  
  Hypersensitivity to any component contained in Spersadex®
comp 
  Injuries and ulcerous processes of the cornea 
  Herpes simplex and other virus conditions