Phenergan

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Promethazine hydrochloride 0.1%{relative}

Dostępny od:

sanofi-aventis new zealand limited

INN (International Nazwa):

Promethazine hydrochloride 0.1% w/v

Dawkowanie:

5mg/5mL

Forma farmaceutyczna:

Elixir

Skład:

Active: Promethazine hydrochloride 0.1%{relative} Excipient: Ascorbic acid Aspartame Caramel Citric acid monohydrate Hyetellose Orange flavour Purified water Sodium benzoate Sodium citrate dihydrate Sodium metabisulfite Sodium sulfite

Sztuk w opakowaniu:

Bottle, glass, 1x100ml, 100 mL

Klasa:

Restricted

Typ recepty:

Restricted

Wyprodukowano przez:

Sanofi Chimie

Podsumowanie produktu:

Package - Contents - Shelf Life: Bottle, glass, 1x100ml - 100 mL - 18 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C

Data autoryzacji:

1969-12-31

Charakterystyka produktu

New Zealand Data Sheet
Phenergan - Promethazine Hydrochloride
phenergan-ccdsv6-dsv12-22apr24
_ _
_Page 1 _
NEW ZEALAND DATA SHEET
1
PHENERGAN TABLETS AND PHENERGAN ELIXIR
Phenergan Tablets 10 mg and 25 mg
Phenergan Elixir 5 mg/5 mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Promethazine hydrochloride
Phenergan Elixir contains promethazine hydrochloride 5 mg/5 mL.
Excipients of known effect: maltitol solution, sodium benzoate, sodium
sulfite, sodium
metabisulfite
Phenergan tablets contain 10 mg or 25 mg of promethazine
hydrochloride.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ELIXIR
5 mg/5 mL. Sugar free, alcohol free, orange flavoured.
TABLETS
10 mg: Circular, film-coated biconvex tablets with bevelled edges,
pale blue in colour, one
face impressed 'PN' above '10', the reverse face plain.
25 mg: Circular, film-coated biconvex tablets with bevelled edges,
pale blue in colour, one
face impressed 'PN' above '25', the reverse face plain.
New Zealand Data Sheet
Phenergan - Promethazine Hydrochloride
phenergan-ccdsv6-dsv12-22apr24
_ _
_Page 2 _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Allergies: Treatment of allergic conditions including some allergic
reactions to drugs,
urticaria and allergic contact dermatitis, and allergic reactions to
insect bites and stings.
Upper respiratory tract: Relief of excessive secretion in the upper
respiratory tract as a result
of hayfever and allergic rhinitis.
Nausea and vomiting: Antiemetic for vomiting from various causes,
including postoperative
vomiting, irradiation sickness, drug induced nausea and motion
sickness.
Sedation: For short term use in adults under the advice of a doctor or
pharmacist. Do not use
for more than 7 to 10 consecutive days.
Other: Promethazine can be used as a preanaesthetic medication for the
prevention and
control of post operative vomiting.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
This product should not be used in children under 6 years of age (