Devatis Sore Throat Relief Spray

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Benzydamine hydrochloride 0.15%{relative}; Chlorhexidine gluconate 0.12%{relative};  ;  

Available from:

Devatis Limited

INN (International Name):

Benzydamine hydrochloride 0.15% w/v

Pharmaceutical form:

Oral spray

Composition:

Active: Benzydamine hydrochloride 0.15%{relative} Chlorhexidine gluconate 0.12%{relative}     Excipient: Ethanol Glycerol Hydrochloric acid Peppermint flavour P0551 957685 Polysorbate 20 Purified water Saccharin sodium Sodium bicarbonate

Prescription type:

General sale

Manufactured by:

Bal Pharma Ltd

Therapeutic indications:

For relief of painful conditions of the throat

Product summary:

Package - Contents - Shelf Life: Bottle, Amber coloured Type 3 glass with Plastic spray pump & polypropylene applicator - 30 mL - 36 months from date of manufacture stored at or below 25°C protect from light. Store in an upright position.

Authorization date:

2016-03-24

Summary of Product characteristics

DEVATIS SORE THROAT RELIEF SPRAY
MODULE 1.3.1 NEW ZEALAND DATA SHEET
DEVATIS LIMITED Property-Strictly confidential
Page 1 / 6
Version: NZ-4
October 2021
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
DEVATIS SORE THROAT RELIEF SPRAY
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
DEVATIS SORE THROAT RELIEF SPRAY contains benzydamine hydrochloride
and chlorhexidine
gluconate.
Each spray delivers 0.195 mg benzydamine hydrochloride (0.15% w/v) and
0.156 mg chlorhexidine gluconate
(0.12% w/v).
EXCIPIENT WITH KNOWN EFFECT:
Contains alcohol (34.5 % w/v).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral Spray.
DEVATIS SORE THROAT RELIEF SPRAY is a colorless to yellowish colored,
clear solution with
peppermint odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is used for mouth and throat antisepsis, for relief of patient's
swallowing function and as symptom reliever
in gingival diseases. It can be used for prophylaxis before dental
procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual dose of DEVATIS SORE THROAT RELIEF SPRAY is 5-10 sprays for
its direct application onto
throat/inflamed area. It is repeated every 1.5-3 hours as necessary.
METHOD OF ADMINISTRATION
DEVATIS SORE THROAT RELIEF SPRAY is used without dilution. DEVATIS
SORE THROAT RELIEF
SPRAY should not be swallowed and should be expectorated after each
use.
Before the initial use, it should be directed into an area away from
the face and pumping button should be
pressed couple of times until a fine spray is obtained.
Mouth should be wide opened; spray nozzle should be put inside the
mouth and sprayed into the oral cavity.
This procedure should be repeated at different areas at least for 4
times.
After application, bottle should be placed inside its box and kept in
upright position.
Chlorhexidine in DEVATIS SORE THROAT RELIEF SPRAY reduces plaque and
gingivitis during
treatment. If DEVATIS SORE THROAT RELIEF SPRAY is used as an
alternative to oral hygiene procedures,
DEVATIS SORE THROAT RELIEF SPRAY shou