Polaramine

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Dexchlorpheniramine maleate 0.4 mg/mL;  

Tilgjengelig fra:

Bayer New Zealand Limited

INN (International Name):

Dexchlorpheniramine maleate 0.4 mg/mL

Dosering :

2 mg/5mL

Legemiddelform:

Syrup

Sammensetning:

Active: Dexchlorpheniramine maleate 0.4 mg/mL   Excipient: Apricot flavour 15502857 Blood orange flavour SC481962 Ethanol Menthol Methyl hydroxybenzoate Ponceau 4R Propyl hydroxybenzoate Purified water Sodium chloride Sodium citrate dihydrate Sorbitol Sucrose

Enheter i pakken:

Bottle, glass, 100mL, 100 mL

Klasse:

Restricted

Resept typen:

Restricted

Produsert av:

Schering-Plough Company

Indikasjoner:

Hayfever and year round allergies: Sneezing, Watery itchy eyes Itchy skin from Hives, Insect bites.

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 500 mL - 36 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

1969-12-31

Informasjon til brukeren

_Polaramine CMI _
_9 October 2017_
Consumer Medicine Information
1
POLARAMINE

DEXCHLORPHENIRAMINE MALEATE
TABLETS 2 MG & SYRUP 0.4 MG/ML
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Polaramine.
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 taking Polaramine against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT POLARAMINE IS USED FOR
Polaramine relieves symptoms associated with allergic rhinitis
(including hayfever), such as
sneezing, runny or itchy nose, and burning or itchy eyes.
Polaramine may also be used to relieve symptoms associated with hives
(also known as
chronic urticaria). These
symptoms include
itching, redness and lumps on the skin.
Polaramine can also be used to treat drug reactions.
Polaramine belongs to a class of medicines known as antihistamines.
Antihistamines help reduce allergic symptoms by preventing the effects
of a substance called
histamine. Histamine is produced by the body in response to foreign
substances which the
body is allergic to.
Your doctor or pharmacist may have prescribed Polaramine for another
reason.
ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT WHY POLARAMINE HAS
BEEN PRESCRIBED FOR YOU.
There is no evidence that Polaramine is addictive.
Polaramine tablets and syrup can be bought without a doctor’s
prescription.
_Polaramine CMI _
_9 October 2017_
Consumer Medicine Information
2
BEFORE YOU TAKE POLARAMINE
_WHEN YOU MUST NOT TAKE IT _
Do not take Polaramine if:
• YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS
LEAFLET.
Some of the symptoms of an allergic reaction may include skin rash,
difficulty
in breathing or faintness.
• YOU ARE ALSO TAKING MEDICINES USED TO TREAT DEPRESSION SUCH AS
MO

Preparatomtale

_ _
_Polaramine Data Sheet _
_17 February 2020_
NEW ZEALAND DATA SHEET
Page 1 of 7
POLARAMINE
®
TABLETS, FILM-COATED – DEXCHLORPHENIRAMINE MALEATE 2 MG
SYRUP - DEXCHLORPHENIRAMINE MALEATE 2 MG/5 ML (0.4 MG/ML)
1.
NAME OF THE MEDICINAL PRODUCT
Polaramine
(dexchlorpheniramine
maleate)
is
the
dextro-isomer
of
chlorpheniramine
maleate.
It
is
an
antihistamine with anticholinergic properties.
Dexchlorpheniramine
maleate
(CAS
no.
2438-32-6)
is
described
chemically
as
(+)-2-[_p_-chloro-α-[2-
(dimethylamino)ethyl]benzyl]pyridine maleate (1:1). It has the
empirical formula of C
16
H
19
ClN
2
.C
4
H
4
O
4
and the
following structural formula:
Dexchlorpheniramine maleate is a white, odourless, crystalline powder
which in aqueous solution has a pH of
between 4 and 5. It is freely soluble in water, soluble in alcohol and
in chloroform, but only slightly soluble in
benzene or ether.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT
All formulations: dexchlorpheniramine maleate
QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT
Polaramine Tablets: dexchlorpheniramine maleate 2 mg
Polaramine Syrup: dexchlorpheniramine maleate 2 mg in 5 mL (0.4 mg/mL)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
POLARAMINE TABLETS
Film-coated, immediate release tablets for oral use.
_Polaramine Data Sheet _
_17 February 2020_
Page 2 of 7
Off-white, round, bevelled tablets with a score-line on one side. The
score line is not intended for breaking the
tablet.
POLARAMINE SYRUP
Syrup for oral use.
A clear, red syrup with an orange-like odour.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Polaramine is indicated for symptomatic treatment of perennial and
seasonal allergic rhinitis, vasomotor rhinitis,
allergic conjunctivitis, mild uncomplicated allergic skin
manifestations of urticaria and angioedema. Polaramine
may relieve itching due to skin conditions such as allergic eczema,
pruritus ani, pruritus vulvae, atopic dermatitis,
contact dermatitis, insect bit