SPRAY-TISH tramazoline hydrochloride 1.18mg/mL spray solution aerosol pump actuated

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

tramazoline hydrochloride, Quantity: 1.18 mg/mL

Предлага се от:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

INN (Международно Name):

tramazoline hydrochloride

Лекарствена форма:

Spray, solution

Композиция:

Excipient Ingredients: purified water; dibasic sodium phosphate dihydrate; citric acid monohydrate; sorbitol solution (70 per cent) (non-crystallising); sodium chloride; benzalkonium chloride

Начин на приложение:

Nasal

Броя в опаковка:

15mL

Вид предписание :

(S2) Pharmacy Medicine

Терапевтични показания:

Symptomatic relief of nasal congestion associated with common cold, hayfever and rhinitis.

Каталог на резюме:

Visual Identification: Amber glass vial, fitted with a metered pump and a polypropylene nasal adapter with a polyethylene protective cap.; Container Type: Aerosol - Pump Actuated; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

1992-11-05

Листовка

SPRAY-TISH
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ACTIVE INGREDIENT: _tramazoline hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using Spray-
Tish. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST
IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY
CONCERNS OR QUESTIONS ABOUT USING SPRAY-TISH.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Spray-Tish?
2. What should I know before I use Spray-Tish?
3. What if I am taking other medicines?
4. How do I use Spray-Tish?
5. What should I know while using Spray-Tish?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING SPRAY-TISH?
SPRAY-TISH CONTAINS THE ACTIVE INGREDIENT TRAMAZOLINE
HYDROCHLORIDE. Spray-Tish is a nasal decongestant. It works
by clearing a stuffy or blocked nose by shrinking the inflamed
and swollen blood vessels in the lining of the nose.
SPRAY-TISH IS USED TO RELIEVE A STUFFY OR BLOCKED NOSE
(NASAL CONGESTION) ASSOCIATED WITH THE COMMON COLD,
HAYFEVER AND RHINITIS. A RUNNY NOSE, NASAL CONGESTION,
ITCHING AND SNEEZING, ARE TYPICAL SYMPTOMS OF A
CONDITION KNOWN AS RHINITIS.
2.
WHAT SHOULD I KNOW BEFORE I USE SPRAY-
TISH?
WARNINGS
DO NOT USE SPRAY-TISH IF:
•
you are allergic to tramazoline hydrochloride, or any of
the ingredients listed at the end of this leaflet. Always
check the ingredients to make sure you can use this
medicine
•
the lining of your nose is dry and has formed crusts or
scabs. For example, a condition called “rhinitis sicca”
•
you have had brain surgery via the nasal cavity
•
you have an eye problem called “narrow-angle
glaucoma”
CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU:
•
have any other medical conditions, including those listed
below:
o
arterial hypertension
o
heart disease
o
an enlarged prostate
o
a rare condition called “porphyria” (a disorder of
blood pigment metabolism)
o
phaechromocytoma (a tumour on the adrenal gland
near the kidney which gives rise to hypertension)
o
an eye problem called “glaucoma”
o
high blood pressure
o
h

Данни за продукта

Property of the Sanofi group -
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1
AUSTRALIAN PRODUCT INFORMATION – SPRAY-TISH
(TRAMAZOLINE HYDROCHLORIDE) SPRAY SOLUTION
1
NAME OF THE MEDICINE
Tramazoline Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Spray-Tish contains the active ingredient tramazoline hydrochloride in
a strength of 1.18
mg/mL.
Benzalkonium chloride 0.182 mg/mL is used as a preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Spray-Tish is a Nasal Mist.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of nasal congestion associated with common
cold, hayfever and
rhinitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and children six years of age and over:
The recommended dose is 1 to 2 sprays into each nostril up to 4 times
a day as required.
Administration should not be continued longer than 3 days without
medical advice.
Directions for Use
Patients should be advised not to pierce the nozzle or attempt to
enlarge the hole, as the
existing hole is designed to deliver the correct dose of Spray-Tish.
To use:
1.
Remove protective cap.
2.
Before using the spray pump for the first time, rapidly depress the
spray pump until an
even spray mist is released. Your Spray-Tish is now primed and ready
for use. With
subsequent use, the spray pump is immediately functional. However, if
used
infrequently, it may require repriming.
Property of the Sanofi group -
spraytish-ccds0159-03-piv7-10mar21
2
3.
Blow nose thoroughly before using Spray-Tish.
4.
Insert the spray adaptor into the nostril and depress the spray pump
while breathing in
gently through the nose. Administer 1 to 2 sprays and then repeat in
the other nostril.
5.
Replace the protective cap after use
It is recommended that the spray adaptor be cleaned after use.
4.3
CONTRAINDICATIONS
Spray-Tish should not be used in:
•
Patients with dry diseases of the nasal mucous membrane which form
crusts and scabs
(rhinitis sicca).
•
Patients after cranial surgery via the nasal cavi