Rexacrom Eye Drops

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Sodium cromoglicate 2%{relative}

Tillgänglig från:

REX Medical Ltd

INN (International namn):

Sodium cromoglicate 2% w/v

Dos:

2% w/v

Läkemedelsform:

Eye drops, solution

Sammansättning:

Active: Sodium cromoglicate 2%{relative} Excipient: Benzalkonium chloride Disodium edetate dihydrate Disodium hydrogen phosphate Polysorbate 80 Water for injection

Enheter i paketet:

Bottle, dropper, LDPE FFS vial with white coloured LDPE ABS cap, 5 mL

Klass:

Pharmacy only

Receptbelagda typ:

Pharmacy only

Tillverkad av:

Olon SpA

Produktsammanfattning:

Package - Contents - Shelf Life: Bottle, dropper, LDPE FFS vial with white coloured LDPE ABS cap - 5 mL - 42 months from date of manufacture stored at or below 25°C protect from light 4 weeks opened stored at or below 25°C protect from light

Tillstånd datum:

2005-02-14

Produktens egenskaper

NEW ZEALAND DATASHEET
1 PRODUCT NAME
Rexacrom eye drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglycate 2% w/v
3 PHARMACEUTICAL FORM
A sterile, clear colourless to pale yellow, preserved, solution
containing 2% w/v of sodium
cromoglycate in a capped vial for ophthalmic administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For
the
prevention
and
treatment
of
allergic
conjunctivitis
(including
seasonal
allergic
conjunctivitis, perennial allergic conjunctivitis and vernal kerato
conjunctivitis).
4.2 Dose and method of administration
ADULTS (INCLUDING THE ELDERLY) & CHILDREN
One or two drops of solution into each eye four times daily.
Care should be taken to avoid contamination of the contents during
use.
4.3 Contraindications
Rexacrom eye drops are contraindicated in patients with known
hypersensitivity to sodium
cromoglycate, or any of the other constituents.
4.4 Special warnings and precautions for use
As with all ophthalmic preparations containing benzalkonium chloride,
patients should be
advised not to wear soft contact lenses during treatment with Rexacrom
eye drops.
4.5 Interaction with other medicines and other forms of interaction
Sodium cromoglycate has been used in many animal drug interaction
studies and for the
treatment of a variety of indications in man. No evidence of
interaction with other drugs has
been observed.
4.6 Fertility, pregnancy and lactation
USE IN PREGNANCY
Category A. Cumulative experience with sodium cromoglycate suggests
that it has no
effects on foetal development. It should be used in pregnancy only if
there is a clear need.
USE IN LACTATION
On the basis of animal studies and its physicochemical properties,
sodium cromoglycate is
considered unlikely to pass into human breast milk. There is no
information to suggest that
use of sodium cromoglycate by nursing mothers has any undesirable
effects on the baby.
FERTILITY
No data available.
4.7 Effects on ability to drive and use machines
Transient stinging or blurring of vision may occur on instillation of
the d