MINIRIN NASAL SPRAY 0.1MGML (RTS)

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

DESMOPRESSIN ACETATE

Διαθέσιμο από:

Ferring Sdn. Bhd.

INN (Διεθνής Όνομα):

DESMOPRESSIN ACETATE

Μονάδες σε πακέτο:

1Units Units; 5.0 ml mL; 2.5 ml mL

Κατασκευάζεται από:

FERRING GMBH

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MINIRIN
® NASAL SPRAY
Desmopressin Acetate (0.1mg/ml)
1
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.
Product Registration Holder and
Manufacturer
10.
Date of revision
WHAT MINIRIN
® IS USED FOR
MINIRIN
®
is used to treat:
i.
Central diabetes insipidus (disorder
which leads to extreme thirst and
large urine volumes).
ii.
Renal concentrating capacity test (a
diagnostic aid in the examination of
the kidney function)
HOW MINIRIN
®
WORKS
Desmopressin is a synthetic version of a
naturally occurring substance produced
in the brain called vasopressin and it
regulates the kidneys ability to
concentrate urine.
BEFORE YOU USE MINIRIN
®
_-When you must not use it _
Do not use MINIRIN
®
if you have:
•
Urine production exceeding 40
ml/kg/24 hours;
•
Heart problems and other conditions
that require treatment with diuretics
(water pills);
•
Moderate and severe kidney
problems;
•
Syndrome of inappropriate
secretion of antidiuretics hormone
(SIADH) causing fluid retention,
resulting in weakness, tiredness or
•
confusion;
•
Low blood sodium level;
•
Hypersensitivity to Desmopressin or
to any of the ingredients.
_-Before you start to use it _
Before starting treatment with
MINIRIN
®
, you should check with your
doctor, if you:
- are 65 years or older,
- have risk for increased pressure in the
skull
- fluid and/or electrolyte imbalance
- suffer from bladder problems e.g.
inability to hold in urine, frequent
urination and/or urgent urination.
- have enlarged prostate.
- have urinary tract infection.
- have bladder stone/growth.
- have excessive thirst.
- have poorly controlled diabetes.
When used for central diabetes
insipidus, experience from clinical use
indicates a risk of severe low blood
sodium levels in association with the
nasal formulation of MINIRIN
®
.
When use

Αρχείο Π.Χ.Π.

PROPOSED PACKAGING MATERIAL
Code
MINSPR-I-MY-01.01
Size
180x250, 180x300, 180x370, 180x420
Submission
☐
NDA
☐
Renewal
☒
Variation change detail no.: PI update with children CDI dose regimen
_ _
Code of previous version
05,36-I-MY-02.02
Changes
Change dosing regimen for CDI in children changed to ‘10 mcg 1-2
times a day’, align with RiMUP
☐
CCDS version:
☐
Core PIL version:
☐
SPC country/version/date:
☐
LAC no.:
Name & Date
JIWO, 04-Mar-2020
MINIRIN
®
Nasal Spray 10mcrog/dose (0.1 mg/ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.1 mg desmopressin acetate equivalent to 89 µg
desmopressin,
and 0.1 mg benzalkonium
chloride.
Excipients: Benzalkonium chloride (solution), sodium chloride, citric
acid monohydrate (E 330), disodium
phosphate dihydrate, and purified water.
PHARMACEUTICAL FORM
Nasal spray, solution.
THERAPEUTIC INDICATIONS
_Central diabetes insipidus _
The use of MINIRIN
®
in patients with an established diagnosis will result in a reduction
in urinary output with
concomitant increase in urine osmolality and decrease in plasma
osmolality. This will result in decreased
urinary frequency and decreased nocturia.
_Renal concentrating capacity test _
MINIRIN
®
can be used to test the capacity of the kidneys to concentrate urine;
as a diagnostic aid in the
examination of the kidney function. This is especially useful in the
differential diagnosis between level of urinary
tract infections. Cystitis will opposite to pyelonephritis not cause a
subnormal ability to concentrate urine.
POSOLOGY AND METHOD OF ADMINISTRATION
General
1 dose of the spray provides 0.1 ml, which corresponds to 10 µg
desmopressin acetate.
MINIRIN
®
nasal formulations should be used only when treatment with oral
formulations is inappropriate and
always start at the lowest dose (see section Special warnings and
precautions for use).
Fluid restriction should be observed (see indication specific
instructions in section Special warnings and
precautions for use).
If signs of water retention and/or hyponatraemia