Florinef

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Fludrocortisone acetate 0.1mg (+5% manufacturing overage)

Beschikbaar vanaf:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Algemene Internationale Benaming):

Fludrocortisone acetate 0.1 mg (+5% manufacturing overage)

Dosering:

0.1 mg

farmaceutische vorm:

Tablet

Samenstelling:

Active: Fludrocortisone acetate 0.1mg (+5% manufacturing overage) Excipient: Calcium hydrogen phosphate dihydrate Lactose monohydrate Magnesium stearate Maize starch Purified talc Sodium benzoate

Eenheden in pakket:

Bottle, Glass, 30 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Farmabios SpA

therapeutische indicaties:

Partial replacement therapy for primary adrenocortical insufficiency in Addison's disease and for the treatment of salt losing adrenogenital syndrome.

Product samenvatting:

Package - Contents - Shelf Life: Bottle, glass, - 30 tablets - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C - Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 3 months opened stored at or below 25°C

Autorisatie datum:

1969-12-31

Bijsluiter

FLORINEF tablets – Consumer Medicine Information - NZ
Page 1 of 2
FLORINEF
_fludrocortisone acetate _
CONSUMER PRODUCT INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Florinef. It does
not contain all of the available
information. It does not take the
place of talking with your doctor
or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Florinef
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 FLORINEF IS USED
FOR
Florinef contains fludrocortisone
acetate as the active ingredient. It
is a type of medicine known as a
corticosteroid.
Florinef is used in combination
with other medicines when there is
an inadequate production of one
type of natural steroid hormone
produced by the adrenal glands
(Addison’s disease).
It is also used to treat a disorder
(called salt-losing adrenogenital
syndrome) which causes too much
salt to be lost in the urine. Florinef
can help treat this condition by
causing the kidneys to retain fluid
and salt in the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another reason.
This medicine is available only
with a doctor’s prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FLORINEF IF YOU HAVE
EVER HAD AN ALLERGY TO
FLUDROCORTISONE ACETATE OR ANY
INGREDIENT LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
to Florinef 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 FLORINEF IF YOU HAVE
A CURRENT SERIOUS OR
UNCONTROLLED INFECTION INCLUDING
SYSTEMIC FUNGAL INFECTIONS.
Your doctor will know if this is the
case and you will be receiving

Productkenmerken

Florinef tablets – New Zealand Data Sheet
Page 1 of 10
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Florinef tablet 0.1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Florinef tablets contain 0.1 mg of fludrocortisone acetate as the
active
ingredient.
Fludrocortisone acetate is a white to pale yellow, odourless or almost
odourless, crystalline powder. Practically insoluble in water; soluble
1 in 50 in
alcohol, 1 in 50 in chloroform; slightly soluble in ether.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Florinef is a white, uncoated tablet with a score line on one side and
“FT 01"
on the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Partial replacement therapy for primary adrenocortical insufficiency
in
Addison's disease and for the treatment of salt losing adrenogenital
syndrome.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADDISON'S DISEASE
The combination of Florinef with a glucocorticoid such as
hydrocortisone or
cortisone provides substitution therapy approximating normal adrenal
activity
with minimal risks of unwanted effects. The usual dose is 0.1 mg of
Florinef
daily, although dosage ranging from 0.1 mg three times a week to 0.2
mg
daily has been employed. In the event transient hypertension develops
as a
consequence of therapy, the dose should be reduced to 0.05 mg daily.
Florinef is preferably administered in conjunction with cortisone (10
to 37.5 mg
daily in divided doses) or hydrocortisone (10 to 30 mg daily in
divided doses).
SALT-LOSING ADRENOGENITAL SYNDROME
The recommended dosage is 0.1 to 0.2 mg of Florinef daily.
4.3 CONTRAINDICATIONS
Patients with systemic fungal infections.
Florinef tablets – New Zealand Data Sheet
Page 2 of 10
Patients with suspected or known hypersensitivity to fludrocortisone
or any on
the inactive ingredients.
Patients on high dose Florinef should not be administered live
vaccines as the
antibody response will be reduced (see section 4.4 Special warnings
and
precautions for use).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of