Pred Forte

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Prednisolone acetate 1%{relative};  

Available from:

AbbVie Limited

INN (International Name):

Prednisolone acetate 1% w/v

Dosage:

1 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Prednisolone acetate 1%{relative}   Excipient: Benzalkonium chloride Boric acid Hydrochloric acid Hypromellose Polysorbate 80 Purified water Sodium chloride Sodium citrate dihydrate Sodium edetate Sodium hydroxide

Units in package:

Bottle, dropper, 5 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Therapeutic indications:

PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, - 5 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Authorization date:

1975-07-10

Summary of Product characteristics

PRED FORTE
®
(prednisolone acetate) 1.0% w/v Datasheet Version 5.0 CCDS v4.0 30 May
2023
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
PRED FORTE
®
1.0% w/v ophthalmic suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Prednisolone acetate 1.0% w/v (microfine suspension)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A topical anti-inflammatory ophthalmic suspension.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PRED FORTE
®
is indicated for the treatment of steroid-responsive inflammation of
the
palpebral and bulbar conjunctiva, cornea and anterior segment of the
globe.
4.2 DOSE AND METHOD OF ADMINISTRATION
SHAKE WELL BEFORE USING.
Instil one drop into the conjunctival sac two to four times daily.
During the initial 24 to 48
hours, the dosing frequency may be increased if necessary. Care should
be taken not to
discontinue therapy prematurely.
If signs and symptoms fail to improve after 2 days, the patient should
be re-evaluated (see
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
_USE IN CHILDREN _
Safety and effectiveness in paediatric patients have not been
established.
Do not give to a child less than 12 years old as this medicine
contains boron and may impair
fertility in the future.
_ _
_USE IN THE ELDERLY: _
No overall differences in safety or effectiveness has been observed
between elderly and young
patients.
4.3 CONTRAINDICATIONS
PRED FORTE
®
suspension is contraindicated in:
•
most viral diseases of the cornea and conjunctiva including
superficial or epithelial
herpes simplex keratitis (dendritic keratitis), vaccinia and
varicella,
•
mycobacterial infection such as tuberculosis of the eye,
•
fungal diseases of ocular structures,
PRED FORTE
®
(prednisolone acetate) 1.0% w/v Datasheet Version 5.0 CCDS v4.0 30 May
2023
2
•
individuals with known or suspected hypersensitivity to the active
substance or to any
of the excipients listed in section 6.1and to other corticosteroids.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS:
Prolonged use of corticosteroids may