Allercrom 2% eye drops

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Sodium cromoglicate

थमां उपलब्ध:

Viatris UK Healthcare Ltd

ए.टी.सी कोड:

S01GX01

INN (इंटरनेशनल नाम):

Sodium cromoglicate

डोज़:

20mg/1ml

फार्मास्यूटिकल फॉर्म:

Eye drops

प्रशासन का मार्ग:

Ocular

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 11040200; GTIN: 5016695004365

सूचना पत्रक

A
PPLICATION
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OR
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HANGES
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ABELS
A
ND
P
ATIENT
I
NFORMATION
L
EAFLETS
(N
OT
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CCOMPANYING
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V
ARIATION
C
HANGE
)
Product name:
ALLERCROM 2% W/V EYE DROPS
Name and address of MA holder:
FDC INTERNATIONAL LTD SODIUM CROMOGLICATE 2% W/V EYE DROPS UNIT 6, FULCRUM 1, SOLENT WAY WHITELEY, FAREHAM, HAMPSHIRE, PO15 7FE
Active substance(s)/quantitative:
SODIUM CROMOGLICATE / 2 % W/V
______________________________________________
Contact:
MR. S K VEERABOMMA
Pharmaceutical form:
EYE DROPS
____________________
Regulatory Affairs Officer
______________________________________________
FDC International Ltd
MA number:
PL 15872/0008
Telephone number: 01489 565 222
PL 15872/0010
Fax number: 01489 565 222
Applicant's reference
: VAR 232
_____________________
E-mail address: [e-mail]
______________________________________________
C
HANGES
P
ROPOSED
T
O
_(Please select ALL that apply) _
1
MAH LABEL

4
OWN LABEL

2
MAH LEAFLET

5
OWN LEAFLET

3
MAH LABEL/LEAFLET

6
OWN LABEL/LEAFLET

_(Please specify Own Label company) _
(Note: Change to different versions of the packaging components should
be submitted on separate application forms).
R
ELATED
A
PPLICATION
(S)
_(Please provide brief information on any ongoing renewal or variation
application(s))_
B
ACKGROUND
(
_Please give brief background explanation for the proposed changes to
your Label/Leaflet. Provide a copy of the _
_current approved version with changes highlighted and attach clean
actual size mock-ups in full colour) _
SUBMISION OF BULK PIQ APPLICATION (CATEGORY P3)
During the approval process of the product, in response to the
information requested received dated
November 31
st
2006 from assessor, Dr. Muhaned Al-Hindawi, shrink wrapping was
introduced for above
product licenses using shrink sleeve to make the product tamper
evidence.
All commercial supplies to date have the shrink sleeve. However, to
comply with Falsified Medicine
Directives (2011/62/EU), “Glued carton” is now introduced for
tamper evidence for above products licenses
t

उत्पाद विशेषताएं

1.
NAME OF THE MEDICINAL PRODUCT
Allercrom 2% w/v Eye Drops
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate (equivalent to 20.0 mg/ml anhydrous Sodium
Cromoglicate).
[Sodium Cromoglicate 2.0% w/v]
For a full list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Eye drops
Sodium cromoglicate 2% w/v eye drops are a clear solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief and treatment of the eye symptoms of hayfever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Allercrom Eye Drops should not be used continuously for more than
14 days except on the advice of a doctor or pharmacist.
Adults and Children over 6 years:
One or two drops to be administered into each eye four times daily.
Elderly:
There is no evidence to suggest that dosage alteration is required for
elderly
patients.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any ingredient, including sodium
cromoglicate,
Benzalkonium Chloride and Disodium Edetate.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This formulation of Sodium Cromoglicate Eye Drops contains
benzalkonium chloride as
a preservative. Benzalkonium chloride may be deposited in soft contact
lenses. Hence,
soft contact lenses should not be worn during treatment with sodium
cromoglicate eye
drops. Other types of contact lenses should be removed before
instillation of the drops
and not reinserted earlier than 15 minutes after use.
Patients should also be instructed that ocular solutions, if handled
improperly can become
contaminated by common bacteria known to cause ocular infections.
Serious damage to
the eye and subsequent loss of vision may result from using
contaminated solutions.
Patients should also be advised that if they develop any intercurrent
ocular condition (e.g.
trauma, ocular surgery or infection), they should immediately seek
their physician's
advice concerning the continued use of present multi-dose container.
There have been
reports of bacterial keratitis associated with the use of topical
ophthalmic products.
The carton label and patient informatio