散克巴點眼液

Country: Taiwan

Language: Chinese

Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Active ingredient:

CYANOCOBALAMIN (VIT B12)

Available from:

台灣參天製藥股份有限公司 台北市中山區松江路126號9樓之1 (86383884)

ATC code:

S01XA

Pharmaceutical form:

點眼液劑

Composition:

CYANOCOBALAMIN (VIT B12) (8811200300) GM

Units in package:

塑膠瓶裝

Class:

製　劑

Prescription type:

醫師藥師藥劑生指示藥品

Manufactured by:

SANTEN PHARMACEUTICAL CO. LTD.(NOTO PLANT) 2-14, SHIKINAMI, HODATSUSHIMIZU-CHO, HAKUI-GUN, ISHIKAWA, JAPAN JP

Therapeutic area:

Other ophthalmologicals

Therapeutic indications:

眼睛疲勞。

Product summary:

有效日期: 2028/03/15; 英文品名: SANCOBA OPHTHALMIC SOLUTION

Authorization date:

2008-10-27

Patient Information leaflet

**Revised: July 2013 (5th version, change of storage condition)
Standard Commodity Classification No. of Japan
*Revised: December 2007
871319
-
OPHTHALMIC PREPARATION FOR IMPROVING ACCOMMODATION FUNCTION
-
SANCOBA

OPHTHALMIC SOLUTION 0.02%
< Cyanocobalamin ophthalmic solution >
DESCRIPTION
Brand name
Sancoba ophthalmic solution 0.02%
Active ingredient
Cyanocobalamin
Content per mL
0.2mg
*Inactive ingredient
Benzalkonium chloride, boric acid and
sodium borate
pH
5.5 - 6.5
Osmotic pressure ratio
About 1
Description
Clear, red sterile aqueous ophthalmic
solution
INDICATIONS
Improvement
of
fluctuation
of
accommodation
in
accommodative asthenopia
DOSAGE AND ADMINISTRATION
Usually, apply 1-2 drops a time to the eye, 3-5 times daily.
The
dosage
may
be
adjusted
according
to
the
patient's
symptoms.
PRECAUTIONS
1.
ADVERSE REACTIONS
The incidence of adverse reactions of this drug has not been
investigated in surveys such as drug use investigation.
If the following adverse reaction is observed, appropriate
measures such as discontinuing administration should be
taken.
INCIDENCE UNKNOWN
Hypersensitivity
Hypersensitivity symptom
2. PRECAUTIONS CONCERNING USE
1) Route of administration: Ophthalmic only
2) At the time of administration: Instruct the patient to be
careful not to touch the tip of the bottle to the eye
directly in order to avoid the contamination of the drug.
PHARMACOKINETICS
1)
INTRAOCULAR DISTRIBUTION
(rabbits)
Labeled
cyanocobalamin
was
instilled
into
the
eyes
of
rabbits 15 times every 2 minutes to the total amount of
0.3mL.
The
penetration
rates
of
cyanocobalamin
into
ocular tissues immediately after and 1 hour after the last
instillation were as follows.
Immediately after
(%)
1 hour after (%)
Conjunctiva
1.286
0.132
Cornea
0.156
0.115
Sclera (ciliary region)
0.097
0.033
Posterior sclera
0.212
0.027
Anterior aqueous humor
0.008
0.015
Crystalline lens
0.007
0.008
Iris
0.015
0.022
Ciliary body
0.045
0.036
Vitreous body
0.007
0.013
Retinochoroid
0.013
0.011
CLINICAL STUDIES
The effectiveness rates of this drug