VOLTAREN OPHTHA EYE DROPS 1 mgml

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
03-09-2010
Tabia za bidhaa Tabia za bidhaa (SPC)
18-01-2018

Viambatanisho vya kazi:

DICLOFENAC SODIUM

Inapatikana kutoka:

NOVARTIS (SINGAPORE) PTE LTD

ATC kanuni:

S01BC03

Kipimo:

1 mg/ml

Dawa fomu:

SOLUTION

Tungo:

DICLOFENAC SODIUM 1 mg/ml

Njia ya uendeshaji:

OPHTHALMIC

Dawa ya aina:

Prescription Only

Viwandani na:

EXCELVISION

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

1997-07-31

Taarifa za kipeperushi

                                 
 
 
 
 
VOLTAREN

 OPHTHA
  
Anti-inflammatory agents, non-steroids. 
COMPOSITION AND PHARMACEUTICAL FORM 
Voltaren Ophtha: one mL contains 1 mg of diclofenac sodium. 
Eye drops, solution. 
For a full list of excipients, see section EXCIPIENTS.  
INDICATIONS 

  Post-operative inflammation following cataract surgery and
other surgical interventions. 

  Preoperative and postoperative prophylaxis of cystoid
macular oedema associated with 
lens extraction and intraocular lens implantation. 

  Post-traumatic inflammation in patients
with non-penetrating wounds 

  Inhibition of miosis during cataract surgery 

  Non-infectious inflammatory conditions affecting the
anterior region of the eye 
DOSAGE AND ADMINISTRATION 
ADULTS: 
EYE SURGERY AND ITS COMPLICATIONS 
Preoperative:  Instill  up  to  5 doses  of  1 drop  each  over  the  course  of  the  3 hours  preceding 
surgery. 
Postoperative: Instill 3 doses of 1 drop each on the day of the operation, followed by 1 drop 
3–5 times daily for as long as necessary. 
TREATMENT OF PAIN AND DISCOMFORT, POST-TRAUMATIC INFLAMMATION 
One drop 4 to 6 hourly.
 
 
ELDERLY: There is no indication that dosage needs to be modified
for the elderly. 
PAEDIATRIC USE:_ _Voltaren Ophtha is not indicated for use in children. Paediatric experience 
is limited to a few published clinical studies in strabismus
surgery.  
The dispenser remains sterile until the original closure is broken. Patients must be instructed 
to  avoid  allowing  the  tip  of  the  dispensing  container  to  contact  the  eye  or  surrounding 
structures as this may contaminate the solution. 
If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes 
between application of the different medicinal products must be
allowed. 
Novarti
                                
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Tabia za bidhaa

                                VOLTAREN

OPHTHA
Anti-inflammatory agents, non-steroids.
COMPOSITION AND PHARMACEUTICAL FORM
Voltaren Ophtha: one mL contains 1 mg of diclofenac sodium.
Eye drops, solution.
For a full list of excipients, see section EXCIPIENTS.
INDICATIONS
•
Post-operative inflammation following cataract surgery and other
surgical interventions.
•
Preoperative and postoperative prophylaxis of cystoid macular oedema
associated with
lens extraction and intraocular lens implantation.
•
Post-traumatic inflammation in patients with non-penetrating wounds
•
Inhibition of miosis during cataract surgery
•
Non-infectious inflammatory conditions affecting the anterior region
of the eye
DOSAGE AND ADMINISTRATION
ADULTS:
EYE SURGERY AND ITS COMPLICATIONS
Preoperative: Instill up to 5 doses of 1 drop each over the course of
the 3 hours preceding
surgery.
Postoperative: Instill 3 doses of 1 drop each on the day of the
operation, followed by 1 drop
3–5 times daily for as long as necessary.
TREATMENT OF PAIN AND DISCOMFORT, POST-TRAUMATIC INFLAMMATION
One drop 4 to 6 hourly.
ELDERLY:
There is no indication that dosage needs to be modified for the
elderly.
PAEDIATRIC USE:
Voltaren Ophtha is not indicated for use in children. Paediatric
experience
is limited to a few published clinical studies in strabismus surgery.
The dispenser remains sterile until the original closure is broken.
Patients must be instructed
to
avoid allowing
the
tip of
the
dispensing container
to contact the
eye or
surrounding
structures as this may contaminate the solution.
If more than one medication needs to be instilled in the eye, an
interval of at least 5 minutes
between application of the different medicinal products must be
allowed.
Novartis
Country Specific Package Leaflet (Singapore)
–
Sep 2015
Page 2
Voltaren Ophtha
Following instillation of the eye drops, nasolacrimal occlusion or
closing the eyes for
5 minutes may reduce systemic absorption. This may result in a
decrease in systemic side
effects and an increase in local activity.
Eye drops are not
                                
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