Dexamethasone phosphate NewLine Pharma 1.37 mg/ml eye drops, solution in single dose container

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

DEXAMETHASONE PHOSPHATE

可用日期:

NewLine Pharma, S.L.

ATC代码:

S01BA01

INN（国际名称）:

DEXAMETHASONE PHOSPHATE

剂量:

1.37 milligram(s)/millilitre

药物剂型:

Eye drops, solution in single-dose container

治疗领域:

dexamethasone

授权状态:

Not marketed

授权日期:

2020-11-27

资料单张

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE PHOSPHATE NEWLINE PHARMA 1.37 MG/ML EYE DROPS, SOLUTION
IN SINGLE DOSE
CONTAINER
dexamethasone sodium phosphate
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 Dexamethasone phosphate NewLine Pharma is and what it is used for
2.
What you need to know before you use Dexamethasone phosphate NewLine
Pharma
3.
How to use Dexamethasone phosphate NewLine Pharma
4.
Possible side effects
5.
How to store Dexamethasone phosphate NewLine Pharma
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE PHOSPHATE NEWLINE PHARMA IS AND WHAT IT IS USED FOR
Dexamethasone phosphate NewLine Pharma contains a substance called
dexamethasone. It is a
corticosteroid which inhibits inflammatory symptoms.
It is indicated for the treatment of non-infectious inflammation of
your eye(s) such as the conjunctiva,
the eyelid and/or the white part of the eye.
Tell your doctor if your condition does not improve after your
prescribed length of treatment or if it
worsens.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DEXAMETHASONE PHOSPHATE NEWLINE
PHARMA
DO NOT USE DEXAMETHASONE PHOSPHATE NEWLINE PHARMA:
-
if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6).
-
if you have high pressure inside the eye (ocular hypertension)
-
if you have eye infection such as herpes simplex, viral infections of
the cornea at ulcerous stage,
tuberculosis or mycosis of the eye, acute purulent ophthalmia,
purulent conjunctiv

产品特点

Health Products Regulatory Authority
22 November 2021
CRN00C6NY
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone phosphate NewLine Pharma 1.37 mg/ml eye drops, solution
in single dose container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 1.37 mg dexamethasone phosphate
equivalent to 1.5 mg dexamethasone sodium phosphate.
Each single-dose container of 0.3 ml contains 8.3 drops of 36
microlitres.
Each drop contains 54 micrograms dexamethasone sodium phosphate.
Excipients with known effect:
1 ml of solution contains 1.465 mg monobasic sodium phosphate
monohydrate and 10 mg disodium phosphate
dodecahydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
Clear and colourless solution, practically free from particles.
pH: 6.7 – 7.7
Osmolality: 0.270 – 0.320 Osmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone phosphate NewLine Pharma is indicated for the treatment
of steroid responsive, non-infectious, inflammatory
conditions of the anterior segment of the eye.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is one drop of Dexamethasone phosphate NewLine Pharma into
the conjunctival sac three to four times daily. The
dose may be adjusted according to clinical requirements.
_Paediatric population_
_ _
The safety and efficacy have not been established in the paediatric
population. No data are available.
Long-term continuous corticosteroid therapy should be avoided due to
possible adrenal suppression (see section 4.4).
Method of administration
For ocular use only. The solution from one individual single dose
container is to be used to the affected eye(s) immediately
after opening for administration.
Patients should be informed of the correct handling of the single-dose
container.
Instructions for use
Patients should be informed of the correct handling of the single-dose
container.
1. Wash hands thoroughly before putting in the eye drops.
2. Make sure the single-dose co