Travatan Z

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Travoprost 0.004%{relative}

Disponível em:

Pharmaco (NZ) Ltd

DCI (Denominação Comum Internacional):

Travoprost 0.004% w/v

Dosagem:

0.004% w/v

Forma farmacêutica:

Eye drops, solution

Composição:

Active: Travoprost 0.004%{relative} Excipient: Boric acid Hydrochloric acid Hydrogenated castor oil Propylene glycol Purified water Sodium hydroxide Sorbitol Zinc chloride

Unidades em pacote:

Bottle, plastic, polypropylene dispenser bottle with dropper tip, 2.5 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Dr Reddy's Laboratories (EU) Ltd

Indicações terapêuticas:

Indicated to decrease elevated intraocular pressure in ocular hypertension and open-angle glaucoma.

Resumo do produto:

Package - Contents - Shelf Life: Bottle, plastic, polypropylene dispenser bottle with dropper tip - 2.5 mL - 24 months from date of manufacture stored at or below 25°C. Do not freeze. 30 days opened - Bottle, plastic, polypropylene dispenser bottle with dropper tip - 5 mL - 24 months from date of manufacture stored at or below 25°C. Do not freeze. 30 days opened

Data de autorização:

2006-06-19

Características técnicas

1
DATA SHEET
TRAVATAN
® Z
TRAVOPROST 0.004% EYE DROPS
NAME OF THE DRUG
TRAVATAN Z Eye Drops contain travoprost. The chemical structure of
travoprost is:
Molecular weight:
500.56
Empirical formula:
C
26
H
35
F
3
O
6
Chemical name:
(5Z,13E)-(9S,11R,15R)-9,11,15-Trihydroxy-16- (_m_- trifluoro
methylphenoxy)-17,18,19,20-tetranor-5,13-prostadienoic acid,
isopropyl ester
CAS Number:
157283-68-6
DESCRIPTION
Travoprost is a clear to slightly opalescent, colourless to yellow
oil. Travoprost is practically
insoluble in water (approximately 44 ppm).
TRAVATAN Z Eye Drops have been formulated as a sterile solution for
topical application to
the eye. The buffered aqueous solution has a pH of approximately 6.0
and an osmolality of
approximately 290 mOsmol/kg. TRAVATAN Z Eye Drops are preserved in the
bottle with an
ionic buffered system.
TRAVATAN Z Eye Drops contain 40 µg/mL travoprost, together with boric
acid, propylene
glycol, polyoxyl 40 hydrogenated castor oil, sorbitol and zinc
chloride, sodium hydroxide
and/or hydrochloric acid to adjust pH, and purified water, USP.
PHARMACOLOGY
_PHARMACOKINETICS _
Travoprost is absorbed into the eye following topical ocular
administration where it is
hydrolysed to the active free acid. Following administration of 1.2
µg
3
H-travoprost in rabbits,
the highest concentrations of radioactivity are found in the cornea,
conjunctiva, aqueous
humour and iris ciliary body. Maximum levels were observed 0.5-2 hours
after instillation.
Radioactivity concentrations in most ocular tissues declined with
half-lives of less than 2
hours (> 10 h in cornea and lens). Systemic exposure is low. Maximum
plasma
concentrations of 0.08 ng equivalent/g were observed at 0.5 hours and
declined rapidly
thereafter.
2
The metabolic pathways of the acid parallel those of endogenous PGF
2α
and are
characterised by reduction of the 13-14 double bond, oxidation of the
15-hydroxyl and
β-oxidative cleavage of the carboxylic acid chain.
Following topical ocular administration of travoprost 0.004% Eye
Drops, preserved w