DDAVP/Desmopressin 100 micrograms/ml Nasal drops solution

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

DESMOPRESSIN ACETATE

Tersedia dari:

Ferring Ireland Limited United Drug House, Magna Drive Magna Business Park, Citywest Road Dublin 24 , Ireland

Kode ATC:

H01BA02

INN (Nama Internasional):

DESMOPRESSIN ACETATE 100 µg/ml

Bentuk farmasi:

NASAL DROPS, SOLUTION

Komposisi:

DESMOPRESSIN ACETATE 100 µg/ml

Jenis Resep:

POM

Area terapi:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2016-08-01

Selebaran informasi

2009053366_s1-1.pdf 1 12/05/14 19.16
DDAVP
®
/ Desmopressin
100 micrograms/ml Nasal Drops, Solution
Desmopressin acetate
DDAVP/Desmopressin Nasal Drops, Solution is for
nasal use only. It contains desmopressin acetate, an
antidiuretic (reduces urine production).
if you have a serious heart or kidney disease
Do not use DDAVP/Desmopressin Nasal Drops,
Solution:
if you are allergic to desmopressin or any of the other
ingredients of this medicine (listed in section 6)
if you are taking diuretics (water tablets)
if you drink unusually large quantities of fluids,
including alcohol
if you have known hyponatraemia (serum sodium
levels below normal range)
If you have syndrome of inappropriate secretion of
anti-diuretic hormone, a hormone regulating urine
production (SIADH)
Please consult your doctor before you use
DDAVP/Desmopressin Nasal Drops, Solution:
Use with caution in very young and older patients.
Renal function testing in children below 1 year old
should only be performed under carefully supervised
conditions in hospital.
if you have an illness causing fluid and/or electrolyte
imbalance e.g. vomiting, diarrhoea, infections, fever
or gastroenteritis
if you have a medical condition that could be made
worse by fluid and/or electrolyte disturbance
(conditions where your blood sodium levels are too
low or you are likely to build up too much water in
your body, e.g. hyponatraemia)
if you suffer from heart disease or reduced kidney
function
if you have cystic fibrosis
if you have difficulty or problems passing urine
if you suffer from bladder problems e.g. incontinence
(inability to hold in urine), hesitance in starting
urination, frequent urination and/or urgent urination
if you have been warned that you are at risk of
increased intracranial pressure
• if you have high blood pressure
If any of these apply to you, or if you are not sure,
contact your doctor before taking
DDAVP/Desmopressin Nasal Drops, Solution.
Tell your doctor or pharmacist if you are using, have
recently used or might use any other medicines.
Plea

Karakteristik produk

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
DDAVP
Desmopressin 100 micrograms/ml Nasal drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 micrograms desmopressin acetate equivalent to 89
microgram desmopressin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal drops, solution.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1. For the diagnosis and treatment of cranial diabetes insipidus
including post-hypophysectomy
polyuria/polydipsia.
2. For the measurement of the urine concentration capacity.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
The rhinyle tube has a graduated scale corresponding to 2.5 µg, 5
µg, 10 µg, 15 µg and 20 µg
desmopressin acetate.
Method of administration: see instruction in sections 6.5 and 6.6.
Fluid restriction should be observed (see indication specific
instructions in section 4.4).
In the event of signs or symptoms of water retention and/or
hyponatraemia (headache,
nausea/vomiting, weight gain, and in severe cases, convulsions)
treatment should be interrupted
until the patient has fully recovered. When restarting treatment
strict fluid restriction should be
enforced (see section 4.4).
INDICATION SPECIFIC
_TREATMENT OF DIABETES INSIPIDUS: _
Adults
Dosage is individual. The dose is usually 10 to 20 micrograms once or
twice daily (equivalent to
0.1ml to 0.2ml once or twice daily).
Children
Dosage is individual. The dose is usually 5 to 10 micrograms once or
twice daily (equivalent to
0.05ml to 0.1ml once or twice daily).
A lower dose may be required for infants.
_DIAGNOSIS OF DIABETES INSIPIDUS: _
Adults and children :
Page 2 of 9
A single dose of 20 micrograms (0.2ml).
_RENAL FUNCTION TESTING: _
To establish renal concentration capacity, the following single doses
are recommended:
Adults: 40 micrograms (0.4ml).
Children > 1 year: 20 micrograms (0.2ml).
Children < 1 year: 10 micrograms (0.1ml).
After administration of DDAVP/Desmopressin Nasal drops solution any
urine collected withi