Intal Forte

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Sodium cromoglicate 5mg equivalent to 3.5211% w/w;  ;  

Inapatikana kutoka:

sanofi-aventis new zealand limited

INN (Jina la Kimataifa):

Sodium cromoglicate 5 mg (equiv to 3.5211% w/w)

Kipimo:

5 mg/dose

Dawa fomu:

Aerosol inhaler, metered dose

Tungo:

Active: Sodium cromoglicate 5mg equivalent to 3.5211% w/w     Excipient: Apaflurane Macrogol 600 Povidone

Vitengo katika mfuko:

Inhaler, metered, 5mg/dose, 112 dose units

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Aventis Pharma Manufacturing Pte Ltd

Matibabu dalili:

INTAL FORTE 5 mg CFC-free is indicated for the preventive treatment of bronchial asthma (which may be due to allergy, exercise, cold air or chemical irritants) in adults and children.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Inhaler, metered, 5mg/dose - 112 dose units - 24 months from date of manufacture stored at or below 30°C

Idhini ya tarehe:

1997-12-11

Taarifa za kipeperushi

Intal
®
Forte
1
INTAL
® FORTE
_CFC-FREE INHALER _
_sodium cromoglycate _
CONSUMER MEDICINE INFORMATION CMI
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Intal Forte CFC-
Free.
It does not contain all the information
that is known about Intal Forte CFC-
Free.
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 using Intal Forte
CFC-Free against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT INTAL FORTE CFC-
FREE IS USED FOR
Intal Forte CFC-Free is inhaled into
the lungs for the treatment of asthma.
Asthma is a disease where the lining
of the lungs becomes inflamed (red
and swollen), making it difficult to
breathe. This may be due to an
allergy to house dust mites, smoke,
air-borne pollution or other irritants.
Intal Forte CFC-Free is used to
prevent bronchial asthma due to
allergy, exercise, cold air or irritants,
in both adults and children.
With regular use, Intal Forte CFC-
Free will help prevent asthma
symptoms from occurring.
Intal Forte CFC-Free will not relieve
the symptoms of an asthma attack
once the attack has started.
YOU SHOULD FOLLOW YOUR DOCTOR'S
ADVICE AND PRESCRIBED TREATMENT TO
GET RELIEF FROM A SUDDEN ASTHMA
ATTACK.
Intal Forte CFC-Free can also be
used before exercise or before
exposure to dust or other known
asthma triggers, such as pollens or
dustmite. This should prevent the
symptoms (wheeze, cough,
breathlessness) these triggers can
cause.
Intal Forte CFC-Free works by
reducing the inflammation of the
airways which occurs in asthma.
Your doctor may have prescribed
Intal Forte CFC-Free for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INTAL FORTE
CFC-FREE HAS BEEN PRESCRIBED FOR
YOU.
There is no evidence that Intal Forte
CFC-Free is addictive.
BEFORE YOU USE INTAL
FORTE CFC-FREE
_WHEN YOU MUST NO

Tabia za bidhaa

New Zealand Data Sheet
19-Sep-2018
Intal Forte - sodium cromoglycate
Property of the Sanofi group - strictly confidential
Intal Forte-ccdsv4-dsv2-19sep18
Page 1
DATA SHEET
1
INTAL FORTE (5MG AEROSOL INHALER, METERED DOSE)
Intal Forte 5 mg aerosol inhaler, metered dose
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active component of INTAL FORTE 5 mg CFC-free is sodium
cromoglycate 3.521% w/w.
Each canister provides at least 112 actuations each containing 5 mg of
sodium cromoglycate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
INTAL FORTE 5 mg CFC-free is presented as a metered dose inhaler
containing sodium
cromoglycate as a suspension in the non - CFC propellant HFA-227, for
inhalation.
Sodium cromoglycate is a white crystalline odourless powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTAL FORTE 5 mg CFC-free is indicated for the preventive treatment of
bronchial asthma
(which may be due to allergy, exercise, cold air or chemical
irritants) in adults and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
INTAL FORTE 5 mg CFC-free therapy is preventative, it is therefore
important that regular
dosing should be maintained. The patient should be advised that
because several doses may be
needed to establish benefit, relief may not be apparent immediately,
but may take some weeks to
develop.
New Zealand Data Sheet
19-Sep-2018
Intal Forte - sodium cromoglycate
Property of the Sanofi group - strictly confidential
Intal Forte-ccdsv4-dsv2-19sep18
Page 2
ADULTS AND CHILDREN
The recommended dosage is 10 mg of sodium cromoglycate (as two 5 mg
inhalations of the
aerosol) four times daily. (The suggested dosage regimen is two
inhalations at bedtime, and on
waking in the morning, and at regular intervals of 3 to 6 hours during
the day). The dose may be
increased to two inhalations six or eight times daily in more severe
cases or during periods of high
antigen challenge.
When the asthmatic condition is stabilised, it is sometimes possible
to reduce the dosage, but this
must be careful