MINIRIN 4 microgram/1mL injection ampoule

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

desmopressin acetate, Quantity: 4 microgram/mL (Equivalent: desmopressin, Qty 3.56 microgram/mL)

Pieejams no:

Ferring Pharmaceuticals Pty Ltd

Zāļu forma:

Injection, solution

Kompozīcija:

Excipient Ingredients: water for injections; sodium chloride; hydrochloric acid

Ievadīšanas:

Intravenous, Intramuscular

Vienības iepakojumā:

10 x 1 mL

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Diabetes Insipidus: The treatment of ADH sensitive cranial diabetes insipidus, including treatment of post hypophysectomy polydipsia and polyuria.,Renal Concentrating Capacity: By intramuscular administration to adults only, as a diagnostic test to establish renal concentrating capacity.,Mild and Moderate Haemophillia A and von Willebrand?s Disease: By intravenous infusion only, for the increase of factor VIII levels in patients undergoing dental or minor surgery. Not to be used in type IIB von Willebrand?s disease since platelet aggregation may be induced.,Bleeding in Patients with Platelet Dysfunction: Treatment of excessive bleeding in patients with congenital or acquired clinical conditions associated with platelet dysfunction which is characterised by a prolonged bleeding time except Glanzmann?s thrombasthenia or platelet cyclo-oxygenase deficiency.,Examples are patients with uraemia, congenital or drug induced platelet dysfunction and patients undergoing cardiac surgery with cardiopulmonary bypass for p

Produktu pārskats:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Autorizācija statuss:

Registered

Autorizācija datums:

1992-08-21

Lietošanas instrukcija

MINIRIN
®
_INJECTION_
_desmopressin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MINIRIN Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you been given MINIRIN
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE YOU WILL BE GIVEN, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MINIRIN
INJECTION IS GIVEN FOR
The active ingredient, desmopressin
acetate in MINIRIN Injection is a
synthetic version of a naturally
occurring substance produced in the
brain called vasopressin.
It has a number of different actions in
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
including:
•
cranial diabetes insipidus (CDI),
large amounts of urine being
produced day and night and
constant thirst where intranasal
administration is inconvenient
•
as a diagnostic test to establish if
the kidneys have the ability to
concentrate urine in adults.
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 ARE GIVEN
MINIRIN INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
MINIRIN INJECTION MUST NOT BE
GIVEN TO YOU 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 body
•
rash,

Produkta apraksts

Page 1 of 12
#151-v11A
AUSTRALIAN PRODUCT INFORMATION
MINIRIN
®
/OCTOSTIM
® (DESMOPRESSIN ACETATE) INJECTIONS
1. NAME OF THE MEDICINE
Desmopressin Acetate
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
MINIRIN Injection contains desmopressin 4 micrograms/mL. OCTOSTIM
Injection contains desmopressin
15 micrograms/mL.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Solution for Injection.
Clear colourless solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Diabetes insipidus (MINIRIN Injection)_ _
The treatment of ADH-sensitive cranial diabetes insipidus, including
treatment of post-hypophysectomy
polydipsia and polyuria.
Renal concentrating capacity (MINIRIN Injection)
By intramuscular administration to adults only, as a diagnostic test
to establish renal concentrating
capacity.
Mild and moderate haemophillia A and von Willebrand’s disease
(MINIRIN and OCTOSTIM Injections)
By intravenous infusion only, for the increase of factor VIII levels
in patients undergoing dental or minor
surgery. Not to be used in type IIB von Willebrand’s disease since
platelet aggregation may be induced.
Bleeding in patients with platelet dysfunction (MINIRIN and OCTOSTIM
Injections)
Treatment of excessive bleeding in patients with congenital or
acquired clinical conditions associated with
platelet
dysfunction
which
is
characterised
by
a
prolonged
bleeding
time
except
Glanzmann’s
thrombasthenia or platelet cyclo-oxygenase deficiency.
Examples are patients with uraemia, congenital or drug induced
platelet dysfunction and patients
undergoing cardiac surgery with cardiopulmonary bypass for prosthetic
valve replacement or aorto-
coronary bypass grafting especially when it is complicated by platelet
function defects sufficient to prolong
bleeding time despite relatively normal platelet cover. Desmopressin
acetate offers no benefit as routine
therapy in patients having an uncomplicated (simple) cardiopulmonary
bypass procedure.
There is no definite evidence of efficacy in bleeding asso