Polargen

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Dexchlorpheniramine maleate 2mg

Tersedia dari:

BioInnova NZ Limited

Dosis:

2 mg

Bentuk farmasi:

Tablet

Komposisi:

Active: Dexchlorpheniramine maleate 2mg Excipient: Lactose monohydrate Magnesium stearate Maize starch Pregelatinised maize starch Purified water

Jenis Resep:

Restricted

Indikasi Terapi:

Latest Regulatory Activity

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC ALU - 20 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC ALU - 40 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Tanggal Otorisasi:

2021-11-12

Karakteristik produk

_Polargen Data Sheet _
_ 05 November 2023 _
Page 1 of 7
NEW ZEALAND DATA SHEET
POLARGEN
TABLETS, UNCOATED – DEXCHLORPHENIRAMINE MALEATE 2 MG
1.
NAME OF THE MEDICINAL PRODUCT
Polargen (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-
-[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
Polargen Tablets: dexchlorpheniramine maleate 2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
POLARGEN TABLETS
Uncoated, immediate release tablets for oral use. Do not halve tablet.
_Polargen Data Sheet _
_ 05 November 2023 _
Page 2 of 7
White, round, flat, uncoated tablets with a score-line on one side &
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Polargen is indicated for symptomatic treatment of perennial and
seasonal allergic rhinitis, vasomotor rhinitis,
allergic conjunctivitis, mild uncomplicated allergic skin
manifestations of urticaria and angioedema. Polargen may
relieve itching due to skin conditions such as allergic eczema,
pruritus ani, pruritus vulvae, atopic dermatitis,
contact dermatitis, insect bites, dermographism and medicine
reactions, including serum sickness.
4.2
DOSE AND METHOD OF ADMINISTRATION
_POLARGEN TABLETS_
_ _
Adults and children over 12 years:
One tablet every 6 hours
After initial relief is obtained, dosage may be reduced