VISCOTEARS Eye gel (2016)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Viscotears Single Dose Unit 2.0mg/g Eye Gel.
2. Qualitative and quantitative composition
2.0mg/g Carbomer (polyacrylic acid). For a full list of excipients, see section 6.1 List of excipients.
3. Pharmaceutical form
Eye Gel.
4.1. Therapeutic indications
Substitute tear fluid for the management of dry eye conditions including keratoconjunctivitis sicca, and for unstable tear film.
4.2. Posology and method of administration
For ocular use. Adults 1 drop 3-4 times daily or as required, depending upon the severity of the disease. Elderly No dosage amendment is necessary in the elderly. Children and adolescents aged to 18 years ...
4.3. Contraindications
Patients with known hypersensitivity to carbomer (polyacrylic acid) or to any of the excipients.
4.4. Special warnings and precautions for use
For ocular use only. If patients experience eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists, they are to discontinue use and consult their doctor. ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. No clinically relevant interactions have been described. In case of any additional local ocular treatment (eg glaucoma therapy) there should be an application ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of carbomer in pregnant women. However no effects during pregnancy are anticipated, since the systemic exposure to carbomer is expected to be negligible. Additionally, ...
4.7. Effects on ability to drive and use machines
Viscotears has no or negligible influence on the ability to drive and use machines. Viscotears may temporarily influence the visual acuity. Patients with blurred vision driving a vehicle or operating machines ...
4.8. Undesirable effects
Summary of the safety profile In clinical trials, the most frequently reported adverse reactions were blurred vision occurring in 11% of patients and eyelid margin crusting occurring in 7.79% of patients. ...
4.9. Overdose
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one tube. Although ...
5.1. Pharmacodynamic properties
Viscotears Single Dose Unit is a preservative-free liquid gel containing carbomer. After local instillation it spreads rapidly over the conjunctiva and cornea and forms a lubricating film with prolonged ...
5.2. Pharmacokinetic properties
There are no controlled animal or human pharmacokinetic studies available. However, absorption or accumulation in eye tissues can presumably be excluded due to the high molecular weight of polyacrylic ...
5.3. Preclinical safety data
The results of the preclinical tests do not add anything of further significance to the prescriber.
6.1. List of excipients
Sorbitol Sodium hydroxide Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. For single use only. Use immediately after first opening.
6.4. Special precautions for storage
Do not store above 25°C. Keep containers in outer carton.
6.5. Nature and contents of container
Transparent LDPE single-dose container containing 0.6ml of gel. Available in packs of 5, 10, 15, 20 and 30 single dose units.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Germany
8. Marketing authorization number(s)
PL13757/0019
9. Date of first authorization / renewal of the authorization
06/12/2004
10. Date of revision of the text
01/11/2016
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