Proculin drops eye (solution)

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

naphazoline (naphazoline hydrochloride)

Disponible des:

Alkaloid AD Skopje

Codi ATC:

S01GA01

Designació comuna internacional (DCI):

naphazoline (naphazoline hydrochloride)

Dosis:

0,3mg/ml

formulario farmacéutico:

drops eye (solution)

Unidades en paquete:

10ml plastic container

tipo de receta:

OTC

Estat d'Autorització:

Registered

Data d'autorització:

2022-01-10

Fitxa tècnica

PROCULIN
®
0.3 mg/ ml
eye drops, solution
_Summary of Product Characteristics _
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PROCULIN
® 0.3 MG/ML EYE DROPS, SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains 0.3 mg naphazoline hydrochloride.
Preservative: benzalkonium chloride 0.06 mg/ ml.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
* eye drops, solution
* clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Conjunctival hyperemia (the preparation enables temporary relief of
the minor eye
symptoms of itching and redness caused by irritants like dust, smoke,
smog, chill, wind,
sun, TV rays, swimming, wearing of contact lenses, working with
objects close to the
eyes);
-
Allergic conjunctivitis caused by pollen, grass, animal hair etc.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Usually 1-2 eye drops should be instilled in the eye(s) up to 4 times
a day.
Recommended treatment duration is 3-4 days.
4.3
CONTRA-INDICATION
-
Hypersensitivity to any component of this preparation;
-
Presence of an anatomically narrow angle or narrow-angle glaucoma.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
The drug should be used with caution in patients with eye infection or
injury,
heart disease,
high blood pressure, diabetes, hyperthyroidism and in patients
receiving MAO – inhibitors.
Safety and effectiveness in pediatric patients have not been
established. Use in children,
especially infants, may result in CNS depression leading to marked
reduction in body
temperature and coma.
Patients should be advised to discontinue the drug and consult a
physician if relief is not
obtained within 48 hours of therapy, if irritation, blurring or
redness persists or increases, or if
symptoms of systemic absorption occur (dizziness, headache, nausea,
decrease in body
PROCULIN
®
0.3 mg/ ml
eye drops, solution
_Summary of Product Characteristics _
2
temperature or drowsiness). Prolonged treatment is not recommended.
Prolonged tre