MINIRIN TABLETS 0.1 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DESMOPRESSIN ACETATE

متاح من:

FERRING PHARMACEUTICALS LTD

ATC رمز:

H01BA02

الشكل الصيدلاني:

TABLETS

تركيب:

DESMOPRESSIN ACETATE 0.1 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FERRING INTERNATIONAL CENTER SA, SWITZERLAND

المجموعة العلاجية:

DESMOPRESSIN

المجال العلاجي:

DESMOPRESSIN

الخصائص العلاجية:

Central diabetes insipidus.Nocturnal Enuresis. Treatment of nocturia in adults associated with nocturnal polyuria.

تاريخ الترخيص:

2014-07-31

نشرة المعلومات

1986
-
REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
This medicine is dispensed with a doctor’s prescription only
MINIRIN TABLETS 0.1 MG
MINIRIN TABLETS 0.2 MG
COMPOSITION:
Each tablet of Minirin 0.1 mg contains:
desmopressin acetate 0.1 mg
Each tablet of Minirin 0.2 mg contains:
desmopressin acetate 0.2 mg
Inactive ingredients - 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, con-
sult 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?
Diabetes insipidus, nocturnal enuresis, nocturia in adults related to
excessive nocturnal
urine production.
THERAPEUTIC GROUP: vasopressin hormone 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
of this medicine (see section 6).
-
if you have a serious heart or kidney disease.
-
if you are taking diuretics.
-
if you drink unusually large quantities of fluids, including alcohol.
-
upon administration for nocturnal enuresis and nocturia: if you are
under 5
years old or over 65 years old.
-
if you have low blood sodium levels (hyponatremia).
-
if you have a medical condition with increased secretion of ADH
(syndrome of
inappropriate secretion of ADH).
During treatment with the medicine, refrain from drinking large
quantity of fluids. Drinking
large quantity of fluids may cause accumulation of water and dilution
of salt concentra-
tion in the body. This is a severe medical problem which may lead to
convulsions.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE:
_Before using the medicine, tell your doctor if you suffer from: _
•
an illness causing fluid and/or electrolyte imbalance, e.g. vomiting,
diarrhea, sys-
temic

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