Minirin

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Desmopressin acetate trihydrate 4 µg/mL equivalent to 3.56 µg/mL desmopressin base

Предлага се от:

Pharmaco (NZ) Ltd

INN (Международно Name):

Desmopressin acetate trihydrate 4 µg/mL (Equiv to 3.56 µg/mL desmopressin base)

дозиране:

4 mcg/mL

Лекарствена форма:

Solution for injection

Композиция:

Active: Desmopressin acetate trihydrate 4 µg/mL equivalent to 3.56 µg/mL desmopressin base Excipient: Hydrochloric acid Sodium chloride Water for injection

Броя в опаковка:

Ampoule, 1mL, 10 dose units

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

PolyPeptide Laboratories AB

Терапевтични показания:

· Treatment of central diabetes insipidus and for establishing renal concentration capacity testing.

Каталог на резюме:

Package - Contents - Shelf Life: Ampoule, 1mL - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Дата Оторизация:

1980-04-11

Листовка

______________________________________________________________________________
MINIRIN
®
Injection
1
MINIRIN

INJECTION
_DESMOPRESSIN ACETATE_
CONSUMER MEDICINE
INFORMATION
IMPORTANT: PLEASE READ THIS
LEAFLET CAREFULLY BEFORE USING
MINIRIN
®
INJECTION. THIS LEAFLET
IS INTENDED TO ANSWER QUESTIONS
YOU MAY HAVE ABOUT MINIRIN
®
INJECTION. 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
®
INJECTION?
MINIRIN Injection contains 4
micrograms of the active
ingredient, desmopressin acetate,
in 1mL solution. It is a clear
colourless solution for injection
packed in 1mL ampoules. The
ampoules are available in boxes
of 10. MINIRIN Injection also
contains the inactive ingredients,
sodium chloride, hydrochloric acid
to adjust the acid/alkali balance
and Water for Injections.
WHAT IS MINIRIN
®
INJECTION USED FOR AND
HOW DOES IT WORK?
The active ingredient of MINIRIN
®
Injection (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
®
Injection can be
used for several different
conditions.
MINIRIN
®
Injection may be used
for treatment of antidiuretic
hormone (ADH)-sensitive Central
Diabetes Insipidus (CDI) where
intranasal administration is
inconvenient.
It may also be used in adults by
intramuscular administration for
testing if the kidneys have the
ability to concentrate urine and for
control of prolonged bleeding or
von Willebrand’s/haemophilia
during surgery.
BEFORE USING MINIRIN
®
INJECTION
_WHEN SHOULD MINIRIN_
_®_
_INJECTION NOT BE USED?_
MINIRIN
®
Injection is not suitable
f

Данни за продукта

NEW ZEALAND DATA SHEET
MINIRIN INJ 003
Nov 2017
Page 1 of 10
MINIRIN 4 MICROGRAM/ML SOLUTION FOR INJECTION
Desmopressin acetate
1 PRODUCT NAME
MINIRIN solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml MINIRIN solution for injection contains desmopressin acetate 4
micrograms equivalent to
desmopressin 3.56 micrograms.
Excipients with known effect
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially sodium-
free.
_ _
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MINIRIN injection is indicated for:

Treatment of central diabetes insipidus and for establishing renal
concentration capacity testing.

Shortening or normalisation of prolonged bleeding time prior to an
invasive therapeutic or
diagnostic operation, or for therapeutic control of bleeding in
patients with prolonged bleeding
time as a consequence of congenital or substance-induced thrombocyte
dysfunction, uremia,
cirrhosis of the liver or in patients with prolonged bleeding time of
unknown etiology.

For the therapeutic control of bleeding and bleeding prophylaxis in
connection with minor
surgical procedures in patients with mild haemophilia A and von
Willebrand’s disease who
respond positively to a test dose. In exceptional cases, even moderate
forms of the disease can
be treated. MINIRIN must not be used in patients with von
Willebrand’s disease type IIB.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ _
_CENTRAL DIABETES INSIPIDUS _
The injection may be used when the intranasal administration is
considered unsuitable. Individual
dosage after testing of the effect on urine osmolality and diuresis at
different dose levels. In the
event of signs of water retention/hyponatremia treatment should be
interrupted and the dose
should be adjusted.
Adults: 1-4mcg (0.25-1ml) in 1-2 divided doses (maximum 4mcg per day).
_ _
_RENAL FUNCTION TESTING _
To establish renal concentration c