Histafen

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Chlorphenamine maleate 0.4 mg/mL; Chlorphenamine maleate 0.4 mg/mL

Inapatikana kutoka:

Douglas Pharmaceuticals Limited

INN (Jina la Kimataifa):

Chlorphenamine maleate 0.4 mg/mL

Kipimo:

2mg/5mL

Dawa fomu:

Elixir

Tungo:

Active: Chlorphenamine maleate 0.4 mg/mL Excipient: Amaranth Ethanol Nipastat Propylene glycol Purified water Raspberry flavour 117668 Saccharin sodium Sodium cyclamate Sorbitol as sorbitol solution 70% Vanillin Active: Chlorphenamine maleate 0.4 mg/mL Excipient: Amaranth Ethanol Nipastat Propylene glycol Purified water Raspberry flavour C3056 Saccharin sodium Sodium cyclamate Sorbitol as sorbitol solution 70% Vanillin

Vitengo katika mfuko:

Bottle, plastic, 2L pack (not marketed), 2 L

Darasa:

Restricted

Dawa ya aina:

Restricted

Viwandani na:

Kongo Chemical Co., Ltd

Bidhaa muhtasari:

Package - Contents - Shelf Life: Bottle, plastic, - 2 L - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 500 mL - 36 months from date of manufacture stored at or below 30°C

Idhini ya tarehe:

1973-03-14

Tabia za bidhaa

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Histafen elixir 2 mg/5 mL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Histafen elixir 2 mg/5 mL contains 0.4 mg/ml of chlorphenamine maleate
(chlorpheniramine
maleate)
EXCIPIENT(S) WITH KNOWN EFFECT
Histafen elixir contains amaranth, ethanol and sorbitol. For the full
list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Red thin liquid with the characteristic odour of raspberry.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Chlorphenamine maleate is indicated for allergic skin disorders
including urticaria, pruritus,
insect bites, some drug allergies and contact allergies to plants. It
is also effective in relieving the
symptoms of seasonal and perennial allergic rhinitis such as sneezing,
nasal itch and
conjunctivitis.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Adults and children over six years of age: 5ml up to eight times
daily.
4.3.
CONTRAINDICATIONS
•
Hypersensitivity to Chlorphenamine maleate or any of the ingredients
listed in section
6.1.
•
Acute attacks of asthma.
•
Do not use in children under six years of age.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of the antimuscarinic properties, antihistamines should be
used with care in conditions
such as narrow angle glaucoma, urinary retention and prostatic
hypertrophy.
2 | P a g e
4.5.
INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
Administration of Histafen elixir with other CNS depressants such as
alcohol, barbiturates,
hypnotics, opioid analgesics, sedatives and antipsychotics may enhance
sedation.
Histafen elixir will enhance the antimuscarinic action of atropine,
tricyclic antidepressants and
Monoamine Oxidase inhibitors (MAOIs).
There is evidence to suggest that antihistamines such as
Chlorphenamine maleate could mask
the warning signs of damage caused by ototoxic medicines such as
aminoglycosides.
Histafen may suppress the cutaneous histamine response to allergen
extracts. Its use should be
stopped several days before skin testing.
4.6.
FERTILITY, PREGNANCY