MIOSTAT INTRAOCULAR SOLUTION 0.01%

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

CARBACHOL

متاح من:

ALCON LABORATORIES (MALAYSIA) SDN. BHD.

INN (الاسم الدولي):

CARBACHOL

الوحدات في الحزمة:

1.5ml mL; 1.5 ml mL

المصنعة من قبل:

Alcon Research LLC

خصائص المنتج

H
HNO
C OCH
2 CH2 CH3 N Cl
CH
3
CH3
-
- -
- --
- +
MIOSTAT*(CARBACHOL INTRAOCULAR
SOLUTION, USP) 0.01%
DESCRIPTION: MIOSTAT* (carbachol intraocular solution, USP)
is a sterile balanced salt solution of carbachol for intraocular
injection. The active ingredient is represented by the chemical
structure:
Established name: Carbachol
Chemical name: Ethanaminium, 2-[(aminocarbonyl)
oxy]-N,N,N- trimethyl-, chloride.
Molecular Formula: C6H15ClN2O2
Molecular Weight: 182.65
Each ml contains: Active: carbachol 0.01%. Inactives:
sodium chloride 0.64%, potassium chloride 0.075%, calcium
chloride dihydrate 0.048%, magnesium chloride hexahydrate
0.03%, sodium acetate trihydrate
0.39%, sodium citrate dehydrate 0.17%, sodium hydroxide
and/or hydrochloric acid (to adjust pH) and Water for Injection.
pH range is 6.5-7.5.
CLINICAL PHARMACOLOGY: Carbachol is a potent cholinergic
(parasympathomimetic) agent which produces constriction of
the iris and ciliary body resulting in reduction in intraocular
pressure. The exact mechanism by which carbachol lowers
intraocular pressure is not precisely known.
INDICATIONS AND USAGE: Intraocular use for obtaining miosis
during surgery. In addition, MIOSTAT (carbachol intraocular
solution, USP) reduces the intensity of intraocular pressure
elevation in the first 24 hours after cataract surgery.
CONTRAINDICATIONS: Should not be used in those persons
showing hypersensitivity to any of the components of this
preparation.
WARNINGS: For single-dose intraocular use only. Discard
unused portion. Intraocular carbachol 0.01% should be used
with caution in patients with acute cardiac failure, bronchial
asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract
obstruction and Parkinson’s disease. The use of intraocular
carbachol 0.01% may increase surgically induced intraocular
inflammation. The vial stopper contains natural rubber (latex)
which may cause severe allergic reactions.
PRECAUTIONS: Use only if the container is undamaged.
Interaction with other Medicinal Products and Other Forms
of Inter