Oxervate
Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Foglio illustrativo
(PIL)
02-06-2023
Scheda tecnica
(SPC)
02-06-2023
Relazione pubblica di valutazione
(PAR)
25-07-2017
Principio attivo:
Recombinant human nerve growth factor
Commercializzato da:
Dompe farmaceutici s.p.a.
Codice ATC:
S01
INN (Nome Internazionale):
cenegermin
Gruppo terapeutico:
Ophthalmologicals
Area terapeutica:
Keratitis
Indicazioni terapeutiche:
Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults
Dettagli prodotto:
Revision: 2
Stato dell'autorizzazione:
Authorised
Data dell'autorizzazione:
2017-07-06
Foglio illustrativo
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OXERVATE 20
MICROGRAMS/ML EYE DROPS, SOLUTION
cenegermin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OXERVATE is and what it is used for
2.
What you need to know before you use OXERVATE
3.
How to use OXERVATE
4.
Possible side effects
5.
How to store OXERVATE
6.
Contents of the pack and other information
1.
WHAT OXERVATE IS AND WHAT IT IS USED FOR
OXERVATE contains the active substance cenegermin. Cenegermin is a
type of nerve growth factor
(a human protein) which is naturally present on the eye surface.
OXERVATE is used to treat adults with moderate or severe
‘neurotrophic keratitis’. This is a disease
affecting the cornea (the transparent layer in the front part of the
eye) which causes defects on the
outer surface of the cornea that do not heal naturally or corneal
ulcers.
OXERVATE is intended to allow the healing of the cornea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXERVATE
DO NOT USE OXERVATE
:
-
if you are allergic to cenegermin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Only use this medicine in your affected eye(s).
Talk to your doctor
BEFORE
using this medicine:
-
if you have an infection in your eye, as the infection should be
treated first. If you get an eye
infection
WHILST
using OXERVATE, you should stop your treatment and consult your doctor
for
advice straightaway.
-
if you have an eye cancer, because this medicine might worsen your
cancer.
-
if you a
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Scheda tecnica
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
OXERVATE 20 micrograms/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 20 micrograms of cenegermin*.
* Recombinant form of human nerve growth factor produced in
_Escherichia Coli_
.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
Clear, colourless solution. pH 7.0-7.4 and osmolarity 280-320 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate (persistent epithelial defect) or severe
(corneal ulcer) neurotrophic keratitis in
adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by an ophthalmologist or
a healthcare professional
qualified in ophthalmology.
Posology
_Adults _
The recommended dose is one drop of OXERVATE in the conjunctival sac
of the affected eye(s), 6
times a day at 2 hourly intervals, starting from the morning and
within 12 hours. Treatment should be
continued for eight weeks.
Patients with an eye infection should be treated before starting
therapy with OXERVATE (see
section 4.4).
If a dose is missed, treatment should be continued as normal, at the
next scheduled administration. The
missed dose can be administered later, within the 12 hours shelf-life
of the daily vial. Patients should
be advised not to instil more than one drop in the affected eye(s)
during any administration.
_Special populations _
_ _
_Elderly _
No dose adjustment is required in patients 65 years of age and older.
_ _
_ _
_Hepatic and renal impairment _
3
The medicinal product has not been studied in patients with hepatic or
renal impairment. However, no
dose adjustment is considered necessary in these populations.
_Paediatric population _
The safety and efficacy of this medicinal product in children and
adolescents below the age of
18 years have not been established. No data are available.
_ _
Method of administration
For ocular use only.
_Precautions to be taken before admin
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