MINIRIN MELT desmopressin 60 micrograms sublingual wafers blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

desmopressin, Quantity: 60 microgram (Equivalent: desmopressin acetate, Qty 68 microgram)

Saadav alates:

Ferring Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Desmopressin

Ravimvorm:

Wafer

Koostis:

Excipient Ingredients: mannitol; citric acid; Gelatin

Manustamisviis:

Sublingual

Ühikuid pakis:

100s, 30s

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

1- Cranial diabetes insipidus. 2- Primary nocturnal enuresis in patients from 6 years of age with normal ability to concentrate urine who are refractory to an enuresis alarm or in whom the enuresis alarm is contraindicated or inappropriate.

Toote kokkuvõte:

Visual Identification: White, round with a drop shaped figure on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2007-06-28

Toote omadused

Page 1 of 9
#16892-v11A
AUSTRALIAN PI - MINIRIN
® (DESMOPRESSIN) MELT
1. NAME OF THE MEDICINE
Desmopressin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MINIRIN Melt, a sublingual wafer, contains the active substance,
desmopressin, (present as the
hydrated acetate), a synthetic structural analogue of the natural
pituitary hormone arginine vasopressin.
The difference lies in the desamination of cysteine and substitution
of L-arginine by D-arginine. MINIRIN
Melt also contains gelatin, mannitol and citric acid.
Desmopressin free base represents approximately 89% of the
desmopressin acetate content. This is
due to the presence of acetic acid/acetate, water and impurities.
3. PHARMACEUTICAL FORM
A white, fluffy powder, soluble in water, in alcohol and in glacial
acetic acid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MINIRIN Melt is indicated for the treatment of
•
cranial diabetes insipidus
•
primary nocturnal enuresis in patients from 6 years of age with normal
ability to concentrate
urine, who are refractory to an enuresis alarm or in whom an enuresis
alarm is
contraindicated or inappropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
MINIRIN Melt is placed under the tongue where it dissolves without the
need for water.
If adequate clinical effect is not achieved within 4 weeks following
appropriate dose titration the
medication should be discontinued.
Food intake may reduce the intensity and duration of the antidiuretic
effect at low oral doses of
MINIRIN tablets (see section 4.5 - INTERACTIONS WITH OTHER MEDICINES
AND OTHER
FORMS OF INTERACTIONS).
CRANIAL DIABETES INSIPIDUS
Dosage is individual in diabetes insipidus but the total daily
sublingual dose normally lies in the range
of 120

g to 720

g. A suitable starting dose in adults and children is 60

g three times daily,
administered sublingually. This dosage regimen should then be adjusted
in accordance with the
patient’s response. For the majority of patients, the maintenance
dose is 60

g to 120

g sublingually
three times daily.
In