Minirin

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Desmopressin acetate trihydrate 100 µg/mL equivalent to 8 9µg/mL Desmopressin free base

Tilgjengelig fra:

Pharmaco (NZ) Ltd

INN (International Name):

Desmopressin acetate trihydrate 100 µg/mL (Equiv to 8 9µg/mL Desmopressin free base)

Dosering :

100 mcg/mL

Legemiddelform:

Nasal drops

Sammensetning:

Active: Desmopressin acetate trihydrate 100 µg/mL equivalent to 8 9µg/mL Desmopressin free base Excipient: Chlorobutanol hemihydrate Hydrochloric acid Purified water Sodium chloride

Enheter i pakken:

Bottle, dropper, 2.5 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

PolyPeptide Laboratories AB

Indikasjoner:

MINIRIN nasal drops solution is indicated for the treatment of central diabetes insipidus and for establishing renal concentration capacity testing.

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, dropper, - 2.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisasjon dato:

1975-12-18

Informasjon til brukeren

______________________________________________________________________________
MINIRIN
®
Nasal Drops
1
MINIRIN

NASAL
DROPS_ _
_DESMOPRESSIN ACETATE _
CONSUMER MEDICINE
INFORMATION
IMPORTANT: PLEASE READ THIS
LEAFLET CAREFULLY BEFORE USING
MINIRIN
® NASAL DROPS. THIS
LEAFLET IS INTENDED TO ANSWER
QUESTIONS YOU MAY HAVE ABOUT
MINIRIN
® NASAL DROPS. IT DOES
NOT REPLACE THE ADVICE FROM
YOUR DOCTOR OR PHARMACIST. IF
YOU HAVE ANY QUESTIONS BEFORE,
DURING OR AFTER USING THIS
MEDICATION BE SURE TO ASK YOUR
DOCTOR OR PHARMACIST.
_ _
WHAT IS MINIRIN
® NASAL
DROPS?
MINIRIN Nasal Drops contains
2.5mL solution. Each mL contains
100 micrograms of the active
ingredient, desmopressin acetate
(DDAVP). It also contains the
inactive ingredients chlorbutanol as
a preservative, sodium chloride,
hydrochloric acid to adjust the
acid/alkali balance and purified
water.
WHAT IS MINIRIN
®
NASAL DROPS USED FOR
AND HOW DOES IT WORK?
_ _
The active ingredient in MINIRIN
®
Nasal Drops (desmopressin
acetate) is a synthetic version of a
natural hormone in the body,
called antidiuretic hormone (ADH).
It has a number of different
actions on the body including an
action on the kidneys to reduce
the amount of urine produced.
This means that MINIRIN
®
Nasal
Drops can be used for several
different conditions.
MINIRIN
®
Nasal Drops is most
commonly used to treat nocturnal
enuresis (bedwetting) in patients
over 5 years who have the normal
ability to concentrate urine.
It may also be used for treatment
of antidiuretic hormone (ADH)-
sensitive Central Diabetes
Insipidus (CDI) or testing if the
kidneys have the ability to
concentrate urine.
BEFORE USING MINIRIN
®
NASAL DROPS
_WHEN SHOULD MINIRIN_
_®_
_ NASAL _
_DROPS NOT BE USED? _
MINIRIN
®
Nasal Drops is not
suitable for some patients. You
should not use MINIRIN
®
Nasal
Drops if you:

have a known allergy to any of
the ingredients in this
medication.

are in the habit of drinking
large amounts of fluid.

have heart disease or any
other disease for which you
take diuretics (fluid

Preparatomtale

NEW ZEALAND DATA SHEET
MINIRIN Nasal Drops – MININD005
22 June 2017
Page 1 of 7
MINIRIN 0.1MG/ML NASAL DROPS
Desmopressin acetate
1 PRODUCT NAME
MINIRIN 0.1mg/mL nasal drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1mL contains 0.1mg desmopressin acetate which corresponds to
0.089mg desmopressin per
mL.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal drops are a clear, colourless solution in an amber glass bottle.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MINIRIN nasal drops solution is indicated for the treatment of central
diabetes insipidus and for
establishing renal concentration capacity testing.
MINIRIN nasal drops solution is also indicated for the treatment of
primary nocturnal enuresis in
patients (from 5 years of age) with normal ability to concentrate
urine.
4.2
DOSE AND METHOD OF ADMINISTRATION
The 0.025mL mark corresponds to a 2.5 microgram dose, the 0.05mL mark
to a 5 microgram dose,
the 0.1mL mark to a 10 microgram dose, the 0.15mL mark to a 15
microgram dose, and the 0.2mL
mark to a 20 microgram dose.
_CENTRAL DIABETES INSIPIDUS _
Dosage is individual after testing, but normal dosage for adults is
10-20 micrograms 1-2 times daily.
For
children
5-10
micrograms
1-2
times
daily.
In
the
event
of
signs
of
water
retention/hyponatremia treatment should be interrupted and the dose
should be adjusted.
_PRIMARY NOCTURNAL ENURESIS _
A clinically effective dose is individual and may vary from 10 to 40
micrograms administered
intranasally. A suitable dose is 20 micrograms intranasally at
bedtime. Start at lowest dose.
Increase dose progressively and with caution. Fluid restriction should
be observed, please see
Section
4.4.
In
the
event
of
signs
of
water
retention/hyponatremia,
treatment
should
be
interrupted. Assessment of the necessity of continued treatment should
be made after three
months during one substance-free week.
_RENAL FUNCTION TESTING _
To establish renal concentration capacity, the following single doses
are recommended:
NEW ZEALAND DATA SHEET
MINIRIN N