APO-BECLOMETHASONE NASAL SPRAY SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BECLOMETHASONE DIPROPIONATE

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

R01AD01

INN (Διεθνής Όνομα):

BECLOMETHASONE

Δοσολογία:

50MCG

Φαρμακοτεχνική μορφή:

SUSPENSION

Σύνθεση:

BECLOMETHASONE DIPROPIONATE 50MCG

Οδός χορήγησης:

NASAL

Μονάδες σε πακέτο:

200 DOSES

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CORTICOSTEROIDS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0106320002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1998-10-06

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
APO-BECLOMETHASONE NASAL SPRAY
Beclomethasone Dipropionate Aqueous Suspension
50 mcg / ACT
(0.05% w / w)
Apotex Standard
Corticosteroid for Nasal Use
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
March 11, 2021
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 249318
2
PRODUCT MONOGRAPH
PR
APO-BECLOMETHASONE NASAL SPRAY
Beclomethasone Dipropionate Aqueous Suspension
50 mcg / ACT
(0.05% w / w)
Apotex Standard
THERAPEUTIC CLASSIFICATION
Corticosteroid for Nasal Use
ACTIONS AND CLINICAL PHARMACOLOGY
Beclomethasone dipropionate is a potent anti-inflammatory steroid with
strong topical and weak
systemic activity. When inhaled intranasally at therapeutic doses, it
has a direct anti-
inflammatory action within the nasal mucosa, the mechanism of which is
not yet completely
defined. The minute amount absorbed in therapeutic doses has not been
shown to exert any
apparent clinical systemic effects.
INDICATIONS AND CLINICAL USE
APO-BECLOMETHASONE NASAL SPRAY (beclomethasone dipropionate) is
indicated for
treatment of perennial and seasonal allergic rhinitis, poorly
responsive to conventional treatment.
Beclomethasone dipropionate can significantly delay the recurrence of
nasal polyps in those
patients who have undergone nasal polypectomy. In those patients in
whom polyps do recur,
beclomethasone dipropionate aqueous suspension can prevent their
increase in size.
CONTRAINDICATIONS
APO-BECLOMETHASONE NASAL SPRAY (beclomethasone dipropionate) is
contraindicated
for patients with: active or quiescent tuberculosis of the respiratory
tract or; untreated fungal,
bacterial or viral infections.
APO-BECLOMETHASONE NASAL SPRAY is also contraindicated in patients
with a history of
3
hypersensitivity to any of the ingredients of these preparations.
WARNINGS
Careful attention must be given to patients previously treated for
prolonged periods with systemic
corticosteroids. Transfer to APO-BECLOMETHASONE NASAL SPRAY
(beclomethasone
dipropionate) may cause withdrawal symptoms, e.g., joint and/or
muscular pain, lassitude and
depr