Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of the safety profile
The most commonly reported adverse reactions in patients suffering from neurotrophic keratitis and treated with OXERVATE during clinical studies include eye pain (11.1 %), eye inflammation (8.3 %), which may include anterior chamber inflammation and hyphaema; lacrimation increased (5.6 %), with symptoms such as eye discharge; eyelid pain (5.6 %) and foreign body sensation in the eye (5.6 %).

Eye pain was the most frequently reported adverse reaction, followed by eye irritation and abnormal sensation in the eye, when considering the whole population treated with the medicinal product (i.e.
population included in clinical trials also on indications other than neurotrophic keratitis).

Tabulated list of adverse reactions

The following adverse reactions listed below were observed in clinical studies in patients suffering from neurotrophic keratitis, treated with OXERVATE 20 μg/ml.

Adverse drug reactions are presented below according to MedDRA system organ classification (SOC and Preferred Term Level).
They are ranked according to system organ class and classified according to the following convention: 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 rare (<1/10,000), or not known (cannot be estimated from the available data).

System organ class             Frequency        Adverse reaction
Infections and infestations    Uncommon         Corneal abscess
Nervous system disorders       Common           Headache
Very common      Eye pain
Eye inflammation, eyelid pain, foreign body sensation
Eye disorders                  Common           in the eye, lacrimation increased, blepharitis, conjunctival hyperaemia, photophobia, eye irritation
Uncommon         Corneal neovascularization

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by an online form: http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il).
Additionally, suspected adverse reactions can be reported to drugsafety@mind-farma.com.