GANFORT PF EYE DROPS (Bimatoprost 0.3mgml Timolol 5.0mgml)

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Bimatoprost; Timolol Maleate 6.8 mg/ml eqv Timolol

Disponível em:

ABBVIE PTE. LTD.

Código ATC:

S01ED51

Forma farmacêutica:

SOLUTION, STERILE

Composição:

Bimatoprost 0.3 mg/ml; Timolol Maleate 6.8 mg/ml eqv Timolol 5 mg/ml

Via de administração:

OPHTHALMIC

Tipo de prescrição:

Prescription Only

Fabricado por:

Allergan Pharmaceuticals Ireland

Status de autorização:

ACTIVE

Data de autorização:

2016-03-11

Características técnicas

GANFORT
®
PF eye drops (bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL) Product
Information version 1.0
NAME OF THE MEDICINE
GANFORT
®
PF eye drops
DESCRIPTION
The active constituents of GANFORT
®
PF eye drops are bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL
(with timolol present as timolol maleate).
CHEMICAL STRUCTURE:
HO
HO
OH
CON
H
C
2
H
5
O
N
N
S
N
O
N
H
H
3
C
CH
3
CH
3
H
OH
HO
HO
O
O
_(structure of bimatoprost) _
_ _
_ _
_(structure of timolol maleate) _
CAS Registry No. 155206-00-1
CAS Registry No. 26921-17-5
Bimatoprost is a synthetic prostamide analogue for ophthalmic use. It
is a white to off-white powder and
is very soluble in ethyl alcohol, methyl alcohol and slightly soluble
in water.
CHEMICAL NAME:
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-
pentenyl]cyclopentyl]-N-ethyl-5-heptenamide
MOLECULAR WEIGHT:
415.58
EMPIRICAL FORMULA:
C
25
H
37
NO
4
Timolol maleate is a non-selective beta-adrenergic receptor blocking
agent. It is a white, odourless,
crystalline powder which is soluble in water, methanol and alcohol.
CHEMICAL NAME:
(S)-1-(tert-butylamino)-3- [(4-morpholino-1,2,5-thiadiazol-3-yl) oxy]
- 2-propanol maleate (1:1)
(salt)
MOLECULAR WEIGHT:
432.50 as the maleate salt
EMPIRICAL FORMULA:
C
13
H
24
N
4
O
3
S.C
4
H
4
O
4
COMPOSITION:
GANFORT
®
PF is a sterile ophthalmic solution in a single dose container.
Each mL of GANFORT
®
PF contains:
ACTIVES: Bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL
INACTIVES: sodium chloride, sodium phosphate dibasic heptahydrate,
citric acid monohydrate; and
purified water. Hydrochloric acid and/or sodium hydroxide may be added
to adjust pH. Contains no
antimicrobial agent.
PHARMACOLOGY
_Pharmacotherapeutic group: Ophthalmologicals; beta-blocking agents;
ATC code:_
_ S01ED51_
_ _
GANFORT
®
PF
eye drops (bimatoprost 0.3 mg/mL and timolol 5.0 mg/mL) Product
Information version 1.0
Page 1
_Mechanism of action _
GANFORT
®
PF
consists
of
two
active
substances:
bimatoprost
and
timolol
maleate.
These
two
components decrease elevated intraocular pressure