Coloxyl suppository

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

docusate sodium, Quantity: 100 mg; bisacodyl, Quantity: 10 mg

זמין מ:

Aspen Pharmacare Australia Pty Ltd

טופס פרצבטיות:

Suppository, moulded

הרכב:

Excipient Ingredients: macrogol 400; Hard fat; propylene glycol

מסלול נתינה (של תרופות):

Rectal

יחידות באריזה:

50 suppositories, 5 suppositories, 5 suppositories (E), 50 suppositories (E)

סיווג:

Medicine Registered

סוג מרשם:

Not scheduled. Not considered by committee

סממני תרפויטית:

This product accepted for registration/listing as 'currently supplied' at the time of commencement of the Act. Indications held in ARTG paper records. (Old code) Coloxyl suppositories are indicated for constipation and for evacuation of the bowel prior to an operation, or prior to X-ray or physical examination of the colon.

leaflet_short:

Visual Identification: Waxy mass, firm at storage conditions below 25 C. Colour white or slightly yellow suppository; Container Type: Strip Pack; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

1991-08-30

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION PARLODEL
®
(BROMOCRIPTINE MESILATE
)
TABLET AND HARD CAPSULE
1
NAME OF THE MEDICINE
Bromocriptine mesilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
•
Parlodel tablets and capsules contain bromocriptine mesilate
•
Oral tablets:
➢
2.5 mg bromocriptine (present as 2.9 mg mesilate).
•
Oral capsules:
➢
10 mg bromocriptine (present as 11.5 mg mesilate).
➢
5 mg bromocriptine (present at 5.735 mg mesilate).
•
List of excipients with known effect: lactose and sugars.
•
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Oral tablets:
•
White, coded XC with breakline on one side, SANDOZ on the other side.
Oral capsules:
•
5 mg: opaque white and opaque blue, marked PS
•
10 mg: opaque white
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Prevention of onset of lactation in the puerperium for clearly defined
medical reasons.
Therapy should be continued for 14 days to prevent rebound lactation.
Parlodel should not
be used to suppress established lactation.
•
Treatment of hyperprolactinaemia where surgery and/or radiotherapy are
not indicated or
have already been used with incomplete resolution. Precautions should
be taken to ensure
that the hyperprolactinaemia is not due to severe primary
hypothyroidism. Where the cause
of hyperprolactinaemia is a prolactin-secreting microadenoma or
macroadenoma, Parlodel
is indicated for conservative treatment; prior to surgery in order to
reduce tumour size and
to facilitate removal; after surgery if prolactin level is still
elevated.
•
Adjunctive therapy in the management of acromegaly when:
(1)
The patient refuses surgery and/or radiotherapy
(2)
Surgery and/or radiotherapy has been unsuccessful or full effects are
not expected for
some months
(3) A manifestation of the acromegaly needs to be brought under
control pending surgery
and/or radiotherapy.
2
•
Idiopathic or post-encephalitic Parkinson's disease. It should be
noted that data are not yet
sufficient to evaluate the role of