Chloramphenicol 1% w/w eye ointment

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Chloramphenicol 10 mg/g

Dostupné s:

Devatis Limited

Dávkování:

1% w/w

Léková forma:

Eye ointment

Složení:

Active: Chloramphenicol 10 mg/g Excipient: Liquid paraffin White soft paraffin

Druh předpisu:

Restricted

Terapeutické indikace:

For the treatment of bacterial conjunctivitis. For use under medical supervision only in the treatment of other superficial ocular infections caused by chloramphenicol-sensitive organisms

Přehled produktů:

Package - Contents - Shelf Life: Tube, aluminium, lacquered inside, HDPE cap - 5 g - 36 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Datum autorizace:

2018-02-12

Charakteristika produktu

CHLORAMPHENICOL
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly Confidential
Version: NZ-V02/July 2019
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Chloramphenicol 1% w/w Eye Ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Chloramphenicol Eye Ointment contains 1
EXCIPIENT WITH KNOWN EFFECT:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye ointment.
A yellowish-white, translucent greasy ointment, free of visible
contamination in aluminum tubes
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of bacterial conjunctivitis. For use under medical
supervision only in the treatment of other
superficial ocular infections caused by chloramphenicol
4.2 DOSE AND METHOD OF ADMINISTRATION
POSOLOGY/DURATION AND FREQUENCY OF ADMINISTRATION
For adults and children (2 years and over):
hours for up to 5 days. To minimize contamination do not allow the tip
to contact
Treatment should be continued for at least 48 hours after the eye
appears normal.
METHOD OF ADMINISTRATION
Topical administration to the eye only.
To minimize contamination do not allow the tip to contact the surface
of the eye.
ADDITIONAL INFORMATION ON SPECIAL POPULATIONS
HEPATIC/RENAL IMPAIRMENT
No dosage adjustment is required in patients with impaired hepatic or
renal
PEDIATRIC POPULATION
Chloramphenicol is not recommended for children under 2 years except
on medical advice.
GERIATRIC POPULATION
There is no indication that dosage needs to be modified for the
elderly.
4.3 CONTRAINDICATIONS
Chloramphenicol is contraindicated in individuals with a history
toxic reaction to the medicine.
CHLORAMPHENICOL 1% W/W EYE OINTMENT
MODULE 1.3.1 NEW ZEALAND DATA SHEET
Strictly Confidential
NEW ZEALAND DATA SHEET
Eye Ointment
QUALITATIVE AND QUANTITATIVE COMPOSITION
henicol Eye Ointment contains 1% w/w chloramphenicol.
For the full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
white, translucent greasy ointment, free of visible contamination in
aluminum tubes
PARTICULARS
For the tre