Ralicrom

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Sodium cromoglicate 100mg;  ;  ;  ;  

Доступна з:

Douglas Pharmaceuticals Limited

ІПН (Міжнародна Ім'я):

Sodium cromoglicate 100 mg

Дозування:

100 mg

Фармацевтична форма:

Capsule

Склад:

Active: Sodium cromoglicate 100mg         Excipient: Gelatin Black ink 1014/ SW-9008

Одиниць в упаковці:

Bottle, plastic, 1x100, 100 capsules

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

Aventis Pharma Manufacturing Pte Ltd

Терапевтичні свідчення:

For chronic inflammatory conditions such as proctitis, ulcerative colitis and proctocolitis, and for use in the treatment of food allergic disease.

Огляд продуктів:

Package - Contents - Shelf Life: Bottle, plastic, - 100 capsules - 48 months from date of manufacture stored at or below 30°C

Дата Авторизація:

1977-11-20

інформаційний буклет

CONSUMER MEDICINE INFORMATION
RALICROM™
_Sodium cromoglicate _
100 mg capsules
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING RALICROM.
This
leaflet
answers
some
common
questions
about
Ralicrom.
It
does
not
contain
all
the
available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor
has
weighed
the
risks
of
you
taking
Ralicrom
against the benefits they expect it will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT RALICROM IS USED FOR
Ralicrom
100
mg
capsules
contain
a
medicine
called sodium cromoglicate. It belongs to a group
of medicines called anti-allergics. It works by
preventing the release of the natural substances in
your body that can cause an allergic reaction. It
also lowers your response when you are exposed
to substances to which you are allergic.
Ralicrom
is
used
to
treat
allergic
reactions
to
certain foods and to treat chronic inflammatory
conditions such as proctitis, ulcerative colitis or
proctocolitis (an inflammatory disease of the large
bowel (colon) and/or back passage (rectum)).
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY RALICROM HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE RALICROM
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RALICROM IF YOU HAVE AN ALLERGY TO:
•
any medicine containing sodium cromoglicate
•
any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other parts
of the body
•
hives on the skin, rash, or itching.
DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT.
Check with your doctor first if you are pregnant or
intend
to
become
pregnant
before
taking
Ralicrom.
DO NOT BREASTFEED IF YOU ARE TAKING THIS MEDICI

Характеристики продукта

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ralicrom* 100mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ralicrom 100mg capsule contains 100 mg of sodium cromoglicate.
EXCIPIENT(S) WITH KNOWN EFFECT
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
It is presented in clear/clear hard gelatin capsules, size No. 2,
overprinted with SODIUM
CROMOGLICATE 100 mg in black and containing a white powder.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For chronic inflammatory conditions such as proctitis, ulcerative
colitis and proctocolitis, and for
use in the treatment of food allergic disease.
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
_INITIAL DOSAGE _
Adults
2 capsules four times daily.
Children (2-14 years)
1 capsule four times daily.
Ralicrom should not be used in children under 2 years.
2 | P a g e
_MAINTENANCE DOSAGE _
Adults and Children
Once symptoms are controlled, the dose may be reduced to the lowest
necessary to maintain
freedom from symptoms.
Patients currently treated with other formulations of sodium
cromoglicate should continue with
their normal dosage.
METHOD OF ADMINISTRATION
Ralicrom is a presentation of sodium cromoglicate for oral use. The
capsules maybe swallowed
whole or the powder contents maybe dissolved in a small quantity of
very hot water and diluted
with cold water to drink. Administration as a solution in water is
probably the method of choice.
4.3.
CONTRAINDICATIONS
Ralicrom is contraindicated in patients with known hypersensitivity to
sodium cromoglicate or
any of the other constituents.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None stated.
4.5.
INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
Sodium cromoglicate has been used for the treatment of a variety of
indications in man and it
has been the subject of drug interaction studies in animals. No
harmful interactions with other
drugs are known.
4.6.
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
Category A
Cumulative experience with sodium cromoglicate suggests that it has n