Lataneau Plus 50 microgram/ml + 5 mg/ml Eye Drops, Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Timolol; Latanoprost

Dostupné z:

Alapis S.A.

ATC kód:

S01ED; S01ED51

INN (Medzinárodný Name):

Timolol; Latanoprost

Dávkovanie:

50 mcg+5 milligram(s)/millilitre

Forma lieku:

Eye drops, solution

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Beta blocking agents1); timolol, combinations

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-05-27

Súhrn charakteristických

Health Products Regulatory Authority
14 October 2019
CRN009DFZ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lataneau Plus 50 microgram/ml + 5 mg/ml Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains latanoprost 50 micrograms and timolol maleate
6.83 mg equivalent to 5 mg timolol.
It contains 0.412 mg/ml of benzalkonium chloride solution 50%.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
The solution is a clear colourless liquid. pH 5.5 -6.5.
Osmolality 260-320 mOsm/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with open angle
glaucoma and ocular hypertension who are insufficiently
responsive to topical beta-blockers or prostaglandin analogues.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dosage for adults (including the elderly):
Recommended therapy is one eye drop in 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.
Administration:
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15 minutes (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five minutes apart.
Use in children and adolescents
Safety and effectiveness in children and adolescents has not been
established.
Health Products Regulatory Authority
14 October 2019
CRN009DFZ
Page 2 of 9
4.3 CONTRAINDICATIONS
Lataneu Plus is contraindicated in patients with:
- Reactive airway disease including bronchial asthma or a history of
bronchial asthma, severe chronic obstructive pulmonary
disease.
- Sinus bradycardia, second or third degree atrioventricular block,
overt cardiac failure, cardiogenic shock.
- Hypersensitivity to the active substances or to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_SYSTEMIC EFFECTS _
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