ARTELAC Eye drops, solution (2022)
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Περιεχόμενα
1. Name of the medicinal product
Artelac 3.2 mg/ml Eye Drops, Solution.
2. Qualitative and quantitative composition
Each ml of solution contains 3.2 mg hypromellose equivalent to hypromellose 0.32% w/v. <u>Excipients with known effect:</u> Disodium phosphate dodecahydrate and Sodium dihydrogen phosphate dihydrate (0.051 ...
3. Pharmaceutical form
Eye drops, solution. Sterile solution for eye drops.
4.1. Therapeutic indications
This medicinal product acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva.
4.2. Posology and method of administration
Posology Suitable for use in adults and children. Unless otherwise directed, instill 1 drop into the conjunctival sac (corner of the eye nearest the nose) 3-5 times per day or as required, to provide sufficient ...
4.3. Contraindications
There are no known contra-indications except use in patients hypersensitive to theactive substance (hypromellose) or to any of the excipients.
4.4. Special warnings and precautions for use
If irritation persists or worsens or new eye signs or symptoms develop, discontinue use and consult a doctor. Wearers of soft contact lenses should remove their lenses before Artelac is administered and ...
4.5. Interaction with other medicinal products and other forms of interaction
None.
4.6. Fertility, pregnancy and lactation
Pregnancy Artelac 3.2mg/ml Eye Drops Solution can be used in pregnancy. Breast-feeding Artelac 3.2mg/ml Eye Drops Solution can be used during lactation. Fertility Artelac 3.2mg/ml Eye Drops Solution is ...
4.7. Effects on ability to drive and use machines
Artelac 3.2mg/ml Eye Drops Solution on instillation may cause a short term blurring of vision when first used. If affected wait until vision has cleared before driving or operating machinery.
4.8. Undesirable effects
The following adverse reactions have been reported following administration of Artelac 3.2 mg/ml Eye Drops Solution. Eye disorder <u>Very rare (<1/10,000):</u> Cases of corneal calcification have been ...
4.9. Overdose
None.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Ophthalmologicals: other ophthalmologicals <b>ATC code:</b> S01XA20 Methylhydroxypropylcellulose prolongs adhesion, enhances moistening of the cornea and conjunctiva and ...
5.2. Pharmacokinetic properties
Methylhydroxypropylcellulose does not permeate the cornea or reach the systemic circulation via the ophthalmic vessels.
5.3. Preclinical safety data
Methylhydroxypropylcellulose has proved to be very well tolerated in local toxicity studies.
6.1. List of excipients
Cetrimide Disodium phosphate dodecahydra Sodium dihydrogen phosphate dihydrate Disodium edetate Sorbitol (E420) Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. Discard within 28 days of first opening.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
10 ml round transparent white bottle (LDPE) with white dropper plug (LDPE) and white cap (HDPE).
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bausch + Lomb Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24 PPT3, Ireland
8. Marketing authorization number(s)
PA23259/004/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 09 July 1996 Date of last renewal: 09 July 2006
10. Date of revision of the text
22 March 2022
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