ALOMIDE Eye drops, solution (2019)
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Περιεχόμενα
Name of the medicinal product
ALOMIDE 0.1% w/v.
Qualitative and quantitative composition
Alomide contains 0.1% w/v Lodoxamide (as lodoxamide trometamol).
Pharmaceutical form
Eye Drops, Solution.
Therapeutic indications
ALOMIDE Ophthalmic Solution is indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis, and allergic-atopic conjunctivitis). The etiologic ...
Posology and method of administration
Adults and children: One or two drops in each eye four times a day at regular intervals. Patients should be advised that the effect of ALOMIDE therapy is dependent upon its administration at regular intervals, ...
Contraindications
ALOMIDE is contraindicated in those persons who have a known hypersensitivity to lodoxamide or any component of the medicament.
Special warnings and precautions for use
ALOMIDE is not for injection. The recommended frequency of administration should not be exceeded. Patients should be advised that instillation of eye drops may initially cause discomfort or transient burning ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of ALOMIDE in pregnant-women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a ...
Effects on ability to drive and use machines
Lodoxamide has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ...
Undesirable effects
a. Summary of the safety profile In clinical trials, the most common adverse reaction was ocular discomfort. b. Tabulated list of adverse reactions The following adverse reactions are classified according ...
Overdose
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product. In the event of a topical overdose, flush from the eye with lukewarm water. ...
Pharmacodynamic properties
Pharmacotherapeutic Group Ophthalmologicals: Antiallergics ATC Code: S01GX05 Lodoxamide, a mast cell stabiliser inhibits the in vivo Type I immediate hypersensitivity reaction in animals and man. In vitro ...
Pharmacokinetic properties
The oral bioavailability of <sup>14</sup>C-lodoxamide in man is 71%, approximately 87% of the absorbed drug undergoes bio transformation. The metabolic transformation of lodoxamide results from stepwise ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which were additional to that already included in other sections of the SPC.
List of excipients
Benzalkonium chloride 0.007% w/v Mannitol 4.7 % w/v Hypromellose 0.38% w/v Sodium citrate 0.0415% w/v Citric acid 0.0175% w/v Disodium edetate 0.01% w/v Tyloxapol 0.025% w/v Sodium hydroxide QS pH 5.0 ...
Incompatibilities
None known.
Shelf life
Shelf life: 24 months. The contents and bottle should be discarded one month after opening the container for the first time.
Special precautions for storage
Do not store above 25°C. Store upright.
Nature and contents of container
ALOMIDE is supplied in 5 mL, 10 mL and 15 mL natural, low-density polyethylene bottles with natural, low density polyethylene dispensing plugs and tamper evident polypropylene screw caps. Only 5 mL and ...
Special precautions for disposal and other handling
The dispensing tip should not be touched with the fingers or by the conjunctiva when drops are instilled. The container should be kept tightly closed.
Marketing authorization holder
Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
Marketing authorization number(s)
PL 00101/0987
Date of first authorization / renewal of the authorization
5 September 1991 / 3 May 2002
Date of revision of the text
09 December 2019
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