Desmopressin-PH&T

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Desmopressin acetate trihydrate 0.6mg equivalent to desmopressin 0.089 mg/mL;  

Disponível em:

AFT Pharmaceuticals Ltd

DCI (Denominação Comum Internacional):

Desmopressin acetate trihydrate 0.6 mg (equivalent to desmopressin 0.089 mg/mL)

Dosagem:

0.1 mg/mL

Forma farmacêutica:

Nasal spray solution

Composição:

Active: Desmopressin acetate trihydrate 0.6mg equivalent to desmopressin 0.089 mg/mL   Excipient: Chlorobutanol hemihydrate Hydrochloric acid Nitrogen Purified water Sodium chloride

Unidades em pacote:

Spray bottle, glass, metered, Nasal spray, 6 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

BCN Peptides SA

Resumo do produto:

Package - Contents - Shelf Life: Spray bottle, glass, metered, Nasal spray - 6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Store in upright position. Can be stored at 25°C after opening. Discard contents after 2 months

Data de autorização:

2002-11-04

Folheto informativo - Bula

DESMOPRESSIN PH&T, NASAL SAPRAY
IMPORTANT: PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING
DESMOPRESSIN PH&T
NASAL SPRAY.
WHAT IS IN THIS LEAFLET
This leaflet is intended to answer questions you may have about
Desmopressin PH&T nasal
spray. 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 DESMOPRESSIN PH&T NASAL SPRAY
Each actuation (press of the nozzle) delivers 10 micrograms of
desmopressin acetate. The
spray
also
contains
the
inactive
ingredients
sodium
chloride,
hydrochloric
acid
(for
pH
adjustment), chlorobutanol hemihydrate (preservative) and purified
water.
WHAT IS DESMOPRESSIN PH&T NASAL SPRAY USED FOR AND HOW DOES IT
WORK
The active ingredient of DESMOPRESSIN PH&T Nasal Spray (desmopressin
acetate) is a
synthetic version of a natural hormone in the body called antidiuretic
hormone (ADH). 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 DESMOPRESSIN PH&T nasal spray can
be used for
several different conditions. DESMOPRESSIN PH&T nasal spray is most
commonly used to
treat nocturnal enuresis (bedwetting) in patients who have the normal
ability to concentrate
urine. DESMOPRESSIN PH&T nasal spray may also be used for treatment of
antidiuretic
hormone (ADH)-sensitive Cranial Diabetes Insipidus (CDI) or testing if
the kidneys have the
ability to concentrate urine.
CHECKLIST BEFORE USING DESMOPRESSIN PH&T NASAL SPRAY
_WHEN SHOULD DESMOPRESSIN PH&T NASAL SPRAY NOT BE USED_
Desmopressin PH&T nasal spray is not suitable for some patients. You
should not use
Desmopressin PH&T nasal spray if you:

have a known allergy to any of the ingredients in this medication.

are in the habit of drinking large amounts of fluid.

have heart disease or any other disease for which you take diuretics
(fluid tablets).

have moderately or severely reduced kidney function where you pass
little or no

Características técnicas

NEW ZEALAND DATA SHEET
1.
DESMOPRESSIN PH&T NASAL SPRAY SOLUTION
Desmopressin nasal spray solution 0.1mg/ml
2.
QUALITITATIVE AND QUANTITATIVE COMPOSITION
1ml nasal spray solution contains 0.1mg desmopressin acetate
equivalent to desmopressin 0.089
mg.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray solution.
A clear, colourless solution in a glass bottle.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DESMOPRESSIN PH&T nasal spray solution is indicated for the treatment
of cranial diabetes
insipidus and for establishing renal concentration capacity testing.
DESMOPRESSIN PH&T nasal spray solution is also indicated for the
treatment of primary
nocturnal enuresis in patients (from 5 years of age) with normal
ability to concentrate urine.
4.2
DOSE AND METHOD OF ADMINISTRATION
1 dose of the spray provides 0.1ml, which corresponds to 10μg
desmopressin acetate.
Cranial diabetes insipidus
Dosage is individual after testing, but normal dosage for adults is
10-20μg 1-2 times daily. For
children 5-10μg 1-2 times daily
In the event of signs of water retention/hyponatremia treatment should
be interrupted and the dose
should be adjusted.
Primary nocturnal enuresis
A clinically effective dose is individual and may vary from 10 to
40μg administered intranasally.
A suitable initial dose is 20μg intranasally at bedtime. Fluid
restriction should be observed, please
see under Warnings and Precautions. In the event of signs of water
retention/hyponatremia treatment
should be interrupted. Assessment of the necessity of continued
treatment should be made after three
months during one substance-free week.
Renal function testing
To establish renal concentration capacity, the following single doses
are recommended:
The normal dose for adults is 40μg.
For children over 1 year 20μg
For children under 1 year 10μg
After administration of DESMOPRESSIN PH&T nasal spray solution any
urine collected within
one hour is discarded. During the next 8 hours 2 portions of urine are
collected for osmolality