MINIRIN desmopressin acetate 200 microgram tablet bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

desmopressin acetate, Quantity: 0.2 mg (Equivalent: desmopressin, Qty 178 microgram)

Inapatikana kutoka:

Ferring Pharmaceuticals Pty Ltd

Dawa fomu:

Tablet, uncoated

Tungo:

Excipient Ingredients: magnesium stearate; lactose monohydrate; povidone; potato starch

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

30 tablets, 7 tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Minirin tablets are indicated for the treatment of: cranial diabetes insipidus; primary nocturnal enuresis, in patients from 6 years of age with normal ability to concentrate urine, who are refractory to an enuresis alarm, or in whom an enuresis alarm is contraindicated or inappropriate.

Bidhaa muhtasari:

Visual Identification: White, round, convex tablet with a single score, engraved 0.2.; Container Type: Bottle; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2003-04-02

Taarifa za kipeperushi

MINIRIN
® TABLETS
_Desmopressin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minirin Tablets.
It does not contain all the available
information. It does not replace
talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Minirin
Tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MINIRIN IS USED
FOR
The active ingredient, desmopressin
acetate in Minirin Tablets is a
synthetic version of a naturally
occurring substance produced in the
brain called vasopressin.
It has a number of different actions
on the body including an action on
the kidney to reduce the amount of
urine produced. This means that
Minirin Tablets can be used for
several different conditions
including:
•
primary nocturnal enuresis
(bedwetting) in patients over 6
years of age who have a normal
ability to concentrate urine and
who have not responded to
treatment with an enuresis alarm
or in whom an enuresis alarm is
contraindicated or inappropriate
•
cranial diabetes insipidus (large
amounts of urine being produced
day and night and constant thirst).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
MINIRIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MINIRIN TABLETS IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
desmopressin or any of the
ingredients listed at the end of
this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the bo

Tabia za bidhaa

Page 1 of 12
#1735-v23
AUSTRALIAN PI - MINIRIN
® (DESMOPRESSIN ACETATE) TABLETS
1. NAME OF THE MEDICINE
Desmopressin Acetate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Minirin Tablets contain desmopressin, (present as the hydrated acetate
with variable amounts of
acetic acid and water), a synthetic structural analogue of the natural
pituitary hormone arginine
vasopressin. The difference lies in the desamination of cysteine and
substitution of L-arginine by D-
arginine.
Desmopressin free base represents 89% of the desmopressin acetate
content. This is due to the
difference in molecular weight as well as the presence of acetic
acid/acetate, water and impurities.
Desmopressin acetate is a white, fluffy powder, soluble in water, in
alcohol and in glacial acetic
acid.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Minirin Tablets 100 micrograms desmopressin (as desmopressin acetate).
White, oval and convex
tablets with a single score and marked “0.1” on one side.
Minirin Tablets 200 micrograms desmopressin (as desmopressin acetate).
White, round and convex
tablets with a single score and marked “0.2” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Minirin Tablets are indicated for the treatment of
•
cranial diabetes insipidus
•
primary nocturnal enuresis in patients from 6 years of age with normal
ability to concentrate
urine, who are refractory to an enuresis alarm or in whom an enuresis
alarm is contraindicated
or inappropriate.
4.2 DOSE AND METHOD OF ADMINISTRATION
There is no predictable dose equivalence between intranasal and oral
dosing, so individual dose
titration is needed. If adequate clinical effect is not achieved
within 4 weeks following appropriate
dose titration, the medication should be discontinued.
FOR ADH-SENSITIVE CRANIAL DIABETES INSIPIDUS
Dosage is individualised in diabetes insipidus but clinical experience
has shown that the total daily
dose normally lies in the range of