Telnase
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-04-2020
Summary of Product characteristics
(SPC)
19-04-2020
Active ingredient:
Triamcinolone acetonide 0.055%{relative};
Available from:
sanofi-aventis new zealand limited
INN (International Name):
Triamcinolone acetonide 0.055% w/w
Dosage:
55 mcg/dose
Pharmaceutical form:
Nasal spray suspension
Composition:
Active: Triamcinolone acetonide 0.055%{relative} Excipient: Benzalkonium chloride Disodium edetate dihydrate Dispersible cellulose Glucose Hydrochloric acid Polysorbate 80 Purified water Sodium hydroxide
Units in package:
Spray bottle, metered, 120 dose units
Class:
Pharmacy only
Prescription type:
Pharmacy only
Manufactured by:
Sanofi Chimie
Therapeutic indications:
Telnase is indicated for the treatment and prophylaxis of seasonal and perennial allergic rhinitis in adults and children over 6 years of age.
Product summary:
Package - Contents - Shelf Life: Spray bottle, metered, - 120 dose units - 24 months unopened stored at or below 25°C 60 days opened stored at or below 25°C
Authorization date:
1997-07-11
Patient Information leaflet
TELNASE CMI
Page 1
TELNASE
®
(TELL-NAZE)
_Triamcinolone acetonide_
_(try-am-sin-o-lone ass-sea-toe-nide) _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Telnase.
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 or pharmacist has
weighed the risks of you using this
medicine 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 TELNASE IS USED
FOR
Telnase contains a corticosteroid and
is used to treat seasonal allergic
rhinitis (hayfever) and perennial
allergic rhinitis.
Hayfever produces symptoms such as
sneezing, itching and runny nose.
Sometimes you can get these
symptoms all year long and this is
called perennial allergic rhinitis. It is
often caused by dust mites or hair
from a cat or a dog.
Telnase sprayed into your nose will
relieve the sneezing, itchy, runny nose
you experience with hayfever or
perennial allergic rhinitis.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY IT
HAS BEEN RECOMMENDED FOR YOU.
There is no evidence that this
medicine is addictive.
BEFORE YOU USE IT
_WHEN YOU MUST NOT USE IT _
DO NOT USE TELNASE IF YOU HAVE AN
INFECTION OF THE NOSE.
DO NOT USE TELNASE IF YOU HAVE
FREQUENT NOSEBLEEDS.
Your condition may cause
nosebleeds and still require
treatment. Discuss with your doctor
if you have any concerns.
DO NOT USE TELNASE IF YOU ARE
ALLERGIC TO:
ANY MEDICINES CONTAINING
TRIAMCINOLONE ACETONIDE
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET.
ANY OTHER SIMILAR
MEDICINES.
Some symptoms of an allergic
reaction may include:
skin rash,
itching,
shortness of breath or
swelling of the face, lips or
tongue, which may cause
difficulty in swallowing or
breathing.
DO NOT GIVE TELNASE TO A CHILD
UNDER 6 YEARS OF AGE
Read the complete document
Summary of Product characteristics
New Zealand Data Sheet
7-dec-2017
Telnase - Triamcinolone acetonide
Property of the Sanofi group - strictly confidential
telnase-ccdsv5-dsv7-7dec17
Page 1
DATA SHEET
1
TELNASE (55 MICROGRAMS/DOSE NASAL SPRAY
SUSPENSION)
Telnase 55 microgram/dose nasal spray suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Triamcinolone acetonide.
Each 20mL bottle of Telnase contains 16.5g of suspension with 9.075mg
triamcinolone acetonide,
and provides at least 120 actuations, each delivering 55 micrograms
triamcinolone acetonide from
the nose piece to the patient, after an initial priming of five
sprays.
Excipients with known effect: benzalkonium chloride
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Nasal spray suspension.
Telnase is supplied as an unscented, thixotropic suspension of
microcrystalline triamcinolone
acetonide in an aqueous medium, contained in a white 20mL high density
polyethylene (HDPE)
bottle, fitted with a metered-dose spray pump unit containing
triamcinolone acetonide.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Telnase is indicated for the treatment and prophylaxis of seasonal and
perennial allergic rhinitis in
adults and children over 6 years of age.
New Zealand Data Sheet
7-dec-2017
Telnase - Triamcinolone acetonide
Property of the Sanofi group - strictly confidential
telnase-ccdsv5-dsv7-7dec17
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS AND CHILDREN AGED 12 YEARS AND OVER _
The recommended starting dose is 220 micrograms, as two sprays in each
nostril once daily.
Once symptoms are controlled, patients may be maintained on 110
micrograms, as one spray in
each nostril, once daily.
_PAEDIATIC POPULATION _
_Children aged 6 to 12 years _
The maximum recommended dose is 110 micrograms, as one spray in each
nostril, once daily. In
patients with more severe symptoms, a dose of 220 micrograms may be
used. Once symptoms are
controlled patients should be maintained on the lowest effective dose.
_Children under 6 years of age _
The safety and efficacy of Telnase i
Read the complete document
