NEVANAC

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

NEPAFENAC

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

S01BC10

الشكل الصيدلاني:

OPHTHALMIC SUSPENSION

تركيب:

NEPAFENAC 0.1 %

طريقة التعاطي:

OCULAR

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ALCON COUVREUR N.V., BELGIUM

المجموعة العلاجية:

NEPAFENAC

المجال العلاجي:

NEPAFENAC

الخصائص العلاجية:

Prevention and treatment of postoperative pain and inflammation associated with cataract surgery and reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.

تاريخ الترخيص:

2015-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
NEVANAC
®
EYE DROPS, SUSPENSION
ACTIVE INGREDIENT: NEPAFENAC 1mg/ml 0.1%.
Inactive and allergenic ingredients in the preparation:
Refer to section 6 “Further information” and to section
2 “Important information about some of the ingredients
of the medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine.
If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if it seems
to you that their medical condition is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of adults:
- For prevention and treatment of eye pain and
inflammation following cataract surgery.
- To reduce the risk of development of macular
edema (swelling in the posterior segment of the eye)
following cataract surgery in diabetic patients.
THERAPEUTIC GROUP: non-steroidal anti-inflammatory
drugs (NSAIDs)
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are sensitive (allergic) to the active ingredient
nepafenac or to any of the additional ingredients
contained in the medicine (appearing in section 6).
• You are sensitive (allergic) to other non-steroidal
anti-inflammatory drugs (NSAIDs).
• You have suffered in the past from asthma, skin
allergy or severe inflammation in the nose when
using other preparations from the non-steroidal
anti-inflammatory drug (NSAID) group such
as: acetylsalicylic acid, ibuprofen, ketoprofen,
piroxicam, diclofenac.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE BEGINNING TREATMENT WITH NEVANAC, TELL THE
DOCTOR IF:
• you bruise easily or suffer from bleeding problems,
or have suffered from them in the past.
• you have other eye problems (such as eye infection)
or if you are taking other medicines

خصائص المنتج

NEV
API
MAY
22
V3
1.
NAME OF THE MEDICINAL PRODUCT
NEVANAC
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 1 mg nepafenac.
Excipient with known effect:
Each ml of suspension contains 0.05 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophtalmic suspension.
Light yellow to yellow uniform suspension, pH 7.4 (approximately).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEVANAC is indicated in adults for:
- Prevention and treatment of postoperative pain and inflammation
associated with cataract surgery
- Reduction in the risk of postoperative macular oedema associated
with cataract surgery in diabetic
patients.
(see section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, including the elderly
For the prevention and treatment of pain and inflammation, the dose is
1 drop of NEVANAC in the
conjunctival sac of the affected eye(s) 3 times daily beginning 1 day
prior to cataract surgery,
continued on the day of surgery and up to 21 days of the postoperative
period, as directed by the
clinician. An additional drop should be administered 30 to 120 minutes
prior to surgery.
For the reduction in the risk of postoperative macular oedema
associated with cataract surgery in
diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival
sac of the affected eye(s)
3 times daily beginning 1 day prior to cataract surgery, continued on
the day of surgery and up to
60 days of the postoperative period as directed by the clinician. An
additional drop should be
administered 30 to 120 minutes prior to surgery.
_Special populations _
_Patients with renal or hepatic impairment _
_ _
NEVANAC has not been studied in patients with hepatic disease or renal
impairment. Nepafenac is
eliminated primarily through biotransformation and the systemic
exposure is very low following
topical ocular administration. No dose adjustment is warranted in
these patients.
_Paediatric population_
_ _
The safety and efficacy of NEVANAC in children and adolesc