MINIRIN NASAL SPRAY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DESMOPRESSIN ACETATE

Available from:

FERRING PHARMACEUTICALS LTD

ATC code:

H01BA02

Pharmaceutical form:

SOLUTION

Composition:

DESMOPRESSIN ACETATE 0.1 MG/ML

Administration route:

NASAL

Prescription type:

Required

Manufactured by:

FERRING GmbH ,GERMANY

Therapeutic group:

DESMOPRESSIN

Therapeutic area:

DESMOPRESSIN

Therapeutic indications:

Diabetes Insipidus.

Authorization date:

2011-12-31

Summary of Product characteristics

1.
_NAME OF MEDICINAL PRODUCT _
MINIRIN MELT 60 MICROGRAMS
MINIRIN MELT
120 MICROGRAMS
2.
_QUALITATIVE AND QUANTITATIVE COMPOSITION_
MINIRIN MELT 60 MCG
: each unit contains 60 micrograms desmopressin (free base), present
as
desmopressin acetate.
MINIRIN MELT 120 MCG
: each unit contains 120 micrograms desmopressin (free base) present
as
desmopressin acetate.
3.
_PHARMACEUTICAL FORM _
Oral lyophilizate
White, round, oral lyophilisate marked with one (60mcg) or two drop
(120mcg) shaped figures on one side.
4.
_CLINICAL PARTICULARS_
4.1 THERAPEUTIC INDICATIONS
Minirin Melt is indicated Nocturnal Enuresis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_NOCTURNAL ENURESIS: _
Oral lyophilisate administration
Children over 5 years:
The recommended initial dose is 120 microg at bedtime, administered
sublingually. If this dose is not
sufficient effective, the dose may be increased up to 240 microg
sublingually.
If treatment continues over the long-term, a treatment-free week
should be introduced every three
months, in order to ascertain whether the condition has resolved
spontaneously.
If the desired clinical effect has not been achieved after 4 weeks of
dose titration, treatment should be
discontinued.
4.3 CONTRA-INDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
•
A history of known or suspected cardiac insufficiency and other
conditions requiring treatment with
diuretic agents. Habitual or psychogenic polydipsia (resulting in a
urine production exceeding 40
ml/kg/24 hours)
•
Patients over the age of 65
•
Moderate and severe renal insufficiency (creatinine clearance below
50ml/min)
•
Known hyponatremia
•
Syndrome of inappropriate ADH secretion (SIADH)
Before prescribing Minirin Melt the diagnosis of psychogenic
polydipsia and alcohol abuse
should be excluded.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_Special warnings: _
When Minirin Melt is used for the treatment of enuresis, the fluid
intake must be limited to a minimum from
1 hour before until