TAPCOM-S OPHTHALMIC SOLUTION

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

Tafluprost; Timolol maleate 6.84 mg/ml eqv timolol

Mevcut itibaren:

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

ATC kodu:

S01ED51

Farmasötik formu:

SOLUTION, STERILE

Kompozisyon:

Tafluprost 0.015 mg/ml; Timolol maleate 6.84 mg/ml eqv timolol 5.00 mg/ml

Uygulama yolu:

OPHTHALMIC

Reçete türü:

Prescription Only

Tarafından üretildi:

Laboratoire Unither

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

2016-08-02

Ürün özellikleri

_TAPCOM_
_®_
_-S OPHTHALMIC SOLUTION_
Tafluprost 15 micrograms/ml and timolol
(as maleate) 5 mg/ml
CONTRAINDICATIONS (THIS PRO-
DUCT IS CONTRAINDICATED IN THE FOLLOWING
PATIENTS.)
Hypersensitivity to the active substances
or to any of the excipients listed in
PHARMACEUTICAL PARTICULARS, 1.
List of excipients.
Reactive airway disease including
bronchial asthma, or a history of bronchial
asthma, severe chronic obstructive
pulmonary disease.
Sinus bradycardia, sick sinus syndrome,
including sino-atrial block, second or third
degree atrioventricular block not controlled
with pace-maker. Overt cardiac failure,
cardiogenic shock.
Patients with combination with products
containing omidenepag isopropyl.
DESCRIPTION
1) PHARMACEUTICAL DOSAGE FORM
Eye drops, solution in single-dose
container (eye drops)
A clear, colourless solution with a pH
of 6.0-6.7 and an osmolality of 290-370
mOsm/kg.
2) QUALITATIVE AND QUANTITATIVE COMPO-
SITION
One ml solution contains: tafluprost 15
micrograms and timolol (as maleate) 5 mg.
One single-dose container (0.3 ml) of eye
drops, solution, contains 4.5 micrograms of
tafluprost and 1.5 mg of timolol.
One drop (about 30 µl) contains about 0.45
micrograms of tafluprost and 0.15 mg of
timolol.
INDICATIONS
Reduction of intraocular pressure (IOP) in
adult patients with open angle glaucoma or
ocular hypertension who are insufficiently
responsive to topical monotherapy with
beta-blockers or prostaglandin analogues
and require a combination therapy, and
who would benefit from preservative free
eye drops.
DOSAGE AND ADMINISTRATION
Posology
Recommended therapy is one eye drop in
the conjunctival sac of the affected eye(s)
once daily.
If one dose is missed, treatment should
continue with the next dose as planned.
The dose should not exceed one drop in the
affected eye(s) daily.
Tapcom-S is a preservative free sterile
solution packaged in a single-dose
container. For single use only, one
container is sufficient to treat both eyes.
Any unused solution should be discarded
immediately after use.
PRECAUTI