OCUFEN Eye drops, solution (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Ocufen.
Qualitative and quantitative composition
Flurbiprofen sodium 0.03% w/v. For a full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, solution.
Therapeutic indications
Ocufen is indicated for: the inhibition of intraoperative miosis. Ocufen does not have intrinsic mydriatic properties and does not replace mydriatic agents. the management of post-operative and post-laser ...
Posology and method of administration
Posology Adult dosage For the inhibition of intraoperative miosis, 1 drop is instilled every half hour starting 2 hours before surgery. The final drop should be given not less than 30 minutes before surgery. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Ocufen is contra-indicated in epithelial herpes simplex keratitis (dendritic keratitis). The potential exists for cross-sensitivity ...
Special warnings and precautions for use
Wound healing may be delayed with the use of Ocufen. There have been reports that Ocufen may cause an increased bleeding tendency of ocular tissues in conjunction with surgery. Patients with a history ...
Interaction with other medicinal products and other forms of interaction
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, ...
Pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of ...
Effects on ability to drive and use machines
Transient blurred vision can result after instillation. If this occurs, the patient should wait until the vision clears before driving or using machinery.
Undesirable effects
The following adverse reactions were reported during the use of Ocufen in clinical studies. Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very ...
Overdose
Overdose by the topical ophthalmic route will not ordinarily cause acute problems. If accidentally ingested, treatment should be symptomatic.
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory agents, non-steroids ATC code: S01BC04 Flurbiprofen sodium is a non steroidal anti inflammatory agent which inhibits prostaglandin synthesis by inhibition of ...
Pharmacokinetic properties
Flurbiprofen concentrations of 213 ng/ml in aqueous humour have been reported following half hourly treatment for two hours preceding surgery.
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in the Summary of Product Characteristics.
List of excipients
Liquifilm (polyvinyl alcohol) Potassium chloride Sodium chloride Sodium citrate dihydrate Citric acid monohydrate Sodium hydroxide or Hydrochloric acid (for pH-adjustment) Purified water
Incompatibilities
Not applicable.
Shelf life
The shelf life is 24 months for the unopened vial. The vial should be discarded after a single dose. The remaining vials should be placed back in the original pouch after each use.
Special precautions for storage
Store at or below 25°C.
Nature and contents of container
Clear, plastic unit dose vial, each containing 0.4 ml of solution.
Special precautions for disposal and other handling
Each vial of Ocufen should be used for a single dose and discarded after use.
Marketing authorization holder
AbbVie Ltd., Maidenhead, SL6 4UB, UK
Marketing authorization number(s)
PL 41042/0072
Date of first authorization / renewal of the authorization
28<sup>th</sup> June 1991 / 17<sup>th</sup> May 2005
Date of revision of the text
01/04/2022
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
