NOCDURNA desmopressin 25 micrograms (as acetate) sublingual wafers blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

desmopressin, Quantity: 0.025 mg

可用日期:

Ferring Pharmaceuticals Pty Ltd

INN（国际名称）:

Desmopressin

药物剂型:

Wafer

组成:

Excipient Ingredients: Gelatin; mannitol; citric acid

给药途径:

Sublingual

每包单位数:

10 sublingual wafers, 30 sublingual wafers

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

NOCDURNA is indicated for the treatment of nocturia due to idiopathic nocturnal polyuria in adults who awaken two or more times each night to void and have not responded to lifestyle measures.,Nocturnal polyuria should be confirmed on the basis of a 24 hour urine frequency-volume diary. It is defined as greater than 33% of urine passed overnight. Secondary causes of nocturia should be excluded (see CONTRAINDICATIONS and PRECAUTIONS).

產品總結:

Visual Identification: White, round, sublingual wafer marked with 25 on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

授权状态:

Licence status A

授权日期:

2016-12-02

资料单张

NOCDURNA
®
(DESMOPRESSIN) SUBLINGUAL WAFERS
1
NOCDURNA
®
_SUBLINGUAL WAFERS _
_desmopressin (as desmopressin acetate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NOCDURNA. 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 taking NOCDURNA
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 NOCDURNA IS
USED FOR
NOCDURNA contains the active
ingredient desmopressin (as
desmopressin acetate). Desmopressin
is a synthetic version of vasopressin,
a naturally occurring substance
produced in the brain.
Like vasopressin, NOCDURNA
works in the kidney as an
antidiuretic, which reduces the
amount of urine that is produced.
NOCDURNA is used to treat adults
who need to get up to urinate at night
(nocturia) at least two or more times,
regardless of lifestyle changes (e.g.
before bedtime drink only enough to
satisfy thirst; and avoid alcohol and
caffeine-containing beverages).
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
NOCDURNA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NOCDURNA 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, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU:

suffer from poly

产品特点

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AUSTRALIAN PRODUCT INFORMATION – NOCDURNA
® (DESMOPRESSIN (AS
ACETATE)) SUBLINGUAL WAFERS
1. NAME OF THE MEDICINE
Desmopressin (as acetate)
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
NOCDURNA contains 25 micrograms or 50 micrograms of desmopressin (as
acetate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Sublingual wafer.
NOCDURNA 25: White, round, sublingual wafer marked with ‘25’ on
one side.
NOCDURNA 50: White, round, sublingual wafer marked with ‘50’ one
one side.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOCDURNA is indicated for the treatment of nocturia due to idiopathic
nocturnal polyuria in adults
who awaken two or more times each night to void and have not responded
to lifestyle
measures.
Nocturnal polyuria should be confirmed on the basis of a 24 h o u r
urine frequency-volume
diary. It
is defined as > 33% of urine passed overnight. Secondary causes of
nocturia
should be excluded (see
SECTIONS 4.3 - CONTRAINDICATIONS and 4.4 - SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
4.2
DOSE AND METHOD OF ADMINISTRATION
Women: 25 micrograms daily, one hour before bedtime, administered
sublingually without water.
Men: 50 micrograms daily, one hour before bedtime, administered
sublingually without water.
_METHOD OF ADMINISTRATION _
NOCDURNA is placed under the tongue where it dissolves without the
need for water.
NOCDURNA should be discontinued if the serum sodium level falls below
the lower limit of
normal
range (135 mmol/L) (see SECTION 4.4 - SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
In
the
event
of
signs
or
symptoms
of
water
retention
and/or
hyponatraemia
(e.g.
headache,
nausea/vomiting, weight gain, and, in severe cases, convulsions)
treatment should be interrupted and
reassessed (see SECTION 4.4 - SPECIAL WARNINGS AND PRECAUTIONS FOR
USE).
Food
intake
may
reduce
the
intensity
and
duration
of
the
antidiuretic
effect
at
low
doses
of
desmopressin (see SECTION 4.5 - INTERACTIONS WITH OTHER MEDICINES AND
OTHER FORMS
OF INTER