Brimonidine Timolol Indoco

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Brimonidine tartrate 2 mg/mL; Timolol maleate 6.8 mg/mL equivalent to timolol 5mg/mL

제공처:

Miro Healthcare Limited

약제 형태:

Eye drops, solution

구성:

Active: Brimonidine tartrate 2 mg/mL Timolol maleate 6.8 mg/mL equivalent to timolol 5mg/mL Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Hydrochloric acid Monobasic sodium phosphate monohydrate Sodium hydroxide Water for injection

처방전 유형:

Prescription

치료 징후:

Brimonidine Timolol Indoco is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension not adequately responding to monotherapy.

제품 요약:

Package - Contents - Shelf Life: Bottle, plastic, LDPE bottle with LDPE nozzle and HDPE cap 1 x 5 mL - 5 mL - 24 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

승인 날짜:

2021-03-31

제품 특성 요약

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Brimonidine Timolol Indoco brimonidine tartrate 2mg/mL and timolol (as
maleate) 5 mg/mL eye drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of Brimonidine Timolol Indoco
eye drops contains2.0mg Brimonidine Tartrate Ph.Eur.
equivalent to 1.3mg of Brimonidine and 6.8mg of Timolol maleate
Ph.Eur. equivalent to 5.0mg of
Timolol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sterile ophthalmic solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Brimonidine Timolol Indoco
eye drops are indicated for the reduction of elevated intraocular
pressure
in patients with open angle glaucoma or ocular hypertension not
adequately responding
to monotherapy.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
The recommended dose is one drop of Brimonidine Timolol Indoco
in the affected eye(s) twice
daily,
approximately 12 hours apart.
In order to minimise systemic absorption of Brimonidine Timolol Indoco
eye drops, apply pressure
to
the tear duct immediately following administration of the drug.
As with all eye drops containing benzalkonium chloride as a
preservative, there is
potential for
incompatibility with other topical ophthalmic medications. If more
than one
topical ophthalmic drug
is to be used, other eye drops should not be used within five to
ten minutes of using Brimonidine
Timolol Indoco
eye drops.
To avoid contamination of the solution, keep container tightly closed.
Do not touch
dropper tip to
any surface.
Discard contents 4 weeks after opening the bottle.
Contents
are sterile if seal is
intact.
_PAEDIATRIC USE_
Safety and effectiveness in paediatric patients have not been
established. During post-
marketing
surveillance, apnea, bradycardia, coma, hypotension, hypothermia,
hypotonia,
lethargy, pallor,
respiratory depression and somnolence have been reported in neonates,
infants and children
receiving brimonidine either for congenital glaucoma or by accidental
ingestion.
See also
Contraindications.
Geriatric Use_ _
No overall differences in safet