EDECOL 2MG/ML EYE DROPS, SOLUTION

Država: Ciper

Jezik: grščina

Source: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Aktivna sestavina:

BRIMONIDINE TARTRATE

Dostopno od:

DELORBIS PHARMACEUTICALS LTD (0000009620) 17 ATHINON STREET, ERGATES INDUSTRIAL AREA, LEFKOSIA, 2081, 28629

Koda artikla:

S01EA05

INN (mednarodno ime):

BRIMONIDINE

Odmerek:

2MG/ML

Farmacevtska oblika:

EYE DROPS, SOLUTION

Sestava:

BRIMONIDINE TARTRATE (8000001808) 2MG

Pot uporabe:

OCULAR USE

Tip zastaranja:

Εθνική Διαδικασία

Terapevtsko območje:

BRIMONIDINE

Povzetek izdelek:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 1 BOTTLE X 5ML (310014001) 5 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Lastnosti izdelka

SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Edecol 2 mg/ml Eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 2.0 mg brimonidine tartrate.
Excipient(s) with known effect: Contains benzalkonium chloride 0.05
mg/ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Edecol 2 mg/ml eye drops, solution is a clear and slightly
greenish-yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure (IOP) in patients with open
angle glaucoma or ocular hypertension.

As monotherapy in patients in whom topical beta-blocker therapy is
contraindicated.

As adjunctive therapy to other intraocular pressure lowering
medications when the target IOP is not achieved
with a single agent (see Section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Recommended dosage in adults (including the elderly)_
The recommended dose is one drop of Edecol in the affected eye(s)
twice daily, approximately 12 hours apart. No
dosage adjustment is required for the use in elderly patients.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac be
compressed at the medial canthus (punctal occlusion) for one minute.
This should be performed immediately
following the instillation of each drop.
If more than one topical ophthalmic drug is to be used, the different
drugs should be instilled 5-15 minutes apart.
1
_Use in renal and hepatic impairment_
Brimonidine tartrate has not been studied in patients with hepatic or
renal impairment (see section 4.4).
_Use in paediatric subjects_
No clinical studies have been performed in adolescents (12 to 17
years).
Edecol is not recommended for use in children below 12 years and is
contraindicated in neonates and infants (less
than 2 years of age) (see sections 4.3, 4.4 and 4.9). It is known that
severe adverse reactions can occur in
neonates. The safety and efficacy of brimonidine tartrate have not
been esta