MINIRIN Oral Lyophilisate for sublingual 120mcg

País: Malásia

Língua: inglês

Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes ativos:

DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE

Disponível em:

Ferring Sdn. Bhd.

DCI (Denominação Comum Internacional):

DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE; DESMOPRESSIN ACETATE

Unidades em pacote:

30tablet Tablets

Fabricado por:

CATALENT UK SWINDON ZYDIS LIMITED

Folheto informativo - Bula

MINIRIN
®
Oral Lyophilisate for sublingual
Desmopressin Acetate 60mcg and 120mcg
Consumer Medication Information Leaflet (RiMUP)
READ THE ENTIRE LEAFLET CAREFULLY
BEFORE
USING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT
INFORMATION FOR YOU.
-
Keep
this
leaflet.
You
may
need to read it again.
-
If
you
have
any
further
questions, ask your doctor or
nurse.
-
This
medicine
has
been
prescribed for you only. Do not
pass
it
on
to
others.
It
may
harm them, even if their signs
of illness are the same as yours.
-
If you get any side effects talk
to your doctor or nurse. This
includes
any
possible
side
effects not listed in the leaflet
WHAT IS IN THIS LEAFLET
:
1.
What MINIRIN
®
is used for
2.
How MINIRIN
®
works
3.
Before you use MINIRIN
®
4.
How to use MINIRIN
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MINIRIN
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MINIRIN
® IS USED FOR
MINIRIN
®
is
provided
as
oral
lyophilisate in sublingual tablet.
It is used to treat:
i.
Central diabetes insipidus.
ii.
Primary
nocturnal
enuresis
(from 5 years of age) when
the
enuresis
alarm
has
not
had
the
desired
effect
in
patients
with
normal
ability
to concentrate urine.
iii.
Symptomatic
treatment
of
nocturia in adults, associated
with nocturnal polyuria, i.e.
nocturnal
urine
production
exceeding bladder capacity.
HOW MINIRIN
®
WORKS
MINIRIN
®
contains
active
ingredient
desmopressin
(free
base),
as
desmopressin
acetate.
Desmopressin
is
a
structural
analogue of the natural hormone
arginine
vasopressin.
It
provides
an
antidiuretic
effect,
lasting
in
most patients for 8-12 hours.
BEFORE YOU USE MINIRIN
®
When you must not use it
Do not use MINIRIN
®
if you are:
•
Habitual
or
psychogenic
polydipsia
(urine
production
exceeding 40 ml/kg/24 hours);
•
Known
or
suspected
cardiac
insufficiency
and
other
conditions
that
require
treatment with diuretics;
•
Moderate
and
severe
renal
insufficiency
(creatinine
clearance below 50 ml/min);
•
Syndrome
of
inappr

Características técnicas

Proposed packaging material
Code (44,45) -I-MY -04.06 Size
Submission ☒NDA ☐Renewal ☐Variation change detail no.: Deficiency letter by NPRA dated 25 -09-2017 Code of p revious version (44,45) -I-MY -04.05 Change s Requested by NPRA to : change product n ame to: oral lyophilisate for sublingual xx mcg ☐CCDS version:
☐Core PIL version:
☐SPC country/version/date:
☐LAC no.:
Name & Date JIWO, 2 5-Sept -2017
MINIRIN ®
Oral Lyophilisates for sublingual 60 mcg and 120 mcg
QUALITATIVE AND QUANTITATIVE COMP OSITION
MINIRIN ® Oral Lyophilisate for sublingual 60 mcg:
One oral lyophilisate contains 60 m cg desmopressin (free base), as desmopressin acetate .
MINIRIN ® Oral Lyophilisate for sublingual 120 mcg:
One oral lyophilisate contains 120 m cg desmopressin (fre e base), as desmopressin acetate .
Excipients : Gelatin (from fish) , mannitol (E4 21) and citric acid , anhydrous (E330) .
PHARMACEUTICAL FORM
Oral lyophilisate
MINIRIN ® Oral Lyophilisate for sublingual 60 mcg:
White, round, oral lyophilisate marked with a d rop shaped figure on one side.
MINIRIN ® Oral Lyophilisate for sublingual 120 mcg:
White, round, oral lyophilisate marked with two drop shaped figures on one side.
THERAPEUTIC INDICATIONS
Central diabetes insipidus.
Primary nocturnal enuresis (from 5 years of age) when the enuresis alarm has not had the desired effect in
patients with normal ability to concentrate urine.
Symptomatic treatment of nocturia in adults, associated with nocturnal polyuria, i.e. nocturnal urine production
exceeding bladder c apacity.
POSOLOGY AND METHOD OF ADMINISTRATION
General
The dose of M INIRIN ® Oral Lyophilisate is individually adapted. MINIRIN ® Oral Lyophilisate 60 mcg is calculated to
correspond to M INIRIN ® tablet 0.1 mg, and 120 mc g corresponds to 0.2 mg (see also sec tion Pharmac okinetic
properties ).
Desmopressin should always be taken at the same time in relation to food intake, since food intake causes
decreased absorption and by that also might influence the effect of desmopressin, see secti