MINIRIN MELT 60 MCG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DESMOPRESSIN AS ACETATE

متاح من:

FERRING PHARMACEUTICALS LTD

ATC رمز:

H01BA02

الشكل الصيدلاني:

TABLETS SOLUBLE

تركيب:

DESMOPRESSIN AS ACETATE 60 MCG

طريقة التعاطي:

SUBLINGUAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FERRING GmbH ,GERMANY

المجموعة العلاجية:

DESMOPRESSIN

المجال العلاجي:

DESMOPRESSIN

الخصائص العلاجية:

Nocturnal enuresis.

تاريخ الترخيص:

2022-10-31

نشرة المعلومات

-
PHARMACISTS' REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH THE
1986
This medicine is dispensed with a doctor’s prescription only
MINIRIN MELT 60 MCG
MINIRIN MELT 120 MCG
TABLETS FOR SUBLINGUAL ADMINISTRATION
ACTIVE INGREDIENTS
Minirin Melt 60 mcg -
Each tablet contains 60 mcg desmopressin free base (added as
desmopressin acetate)
Minirin Melt 120 mcg -
Each tablet contains 120 mcg desmopressin free base (added as
desmopressin acetate)
Inactive ingredients and allergens - see section 6 "Additional
information"
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them even if it seems to you that their illness is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is intended for treatment of bedwetting (nocturnal
enuresis).
THERAPEUTIC GROUP: synthetic vasopressin analog.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
-
you are sensitive (allergic) to desmopressin or to any of the other
ingredients in this
medicine (see section 6)
-
you have a severe heart or kidney disease
-
you are taking diuretics
-
you drink very large quantities of liquids, including alcohol
-
you are below the age of 5 or above the age of 65
-
you have low blood sodium levels (hyponatremia)
-
you have a medical condition associated with increased ADH secretion
(abnormal
ADH secretion syndrome)
AVOID DRINKING LARGE QUANTITY OF FLUIDS DURING TREATMENT WITH THE
MEDICINE.
DRINKING LARGE QUANTITY OF FLUIDS MAY LEAD TO WATER ACCUMULATION AND
DILUTION OF
THE CONCENTRATION OF SALTS IN THE BODY. THIS MAY CAUSE HEADACHE,
NAUSEA/VOMITING, WEIGHT GAIN AND IN SEVERE CASES CONVULSIONS.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
_Before treatment with the medicine_
_, tell your doctor if you have:_
●
A disease causing impaired fluid and/or electrolyte balance.

خصائص المنتج

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