ALKINDI 0.5 MG

País: Israel

Idioma: anglès

Font: Ministry of Health

ingredients actius:

HYDROCORTISONE

Disponible des:

MEDOMIE PHARMA LTD, ISRAEL

Codi ATC:

H02AB09

formulario farmacéutico:

GRANULES IN CAPSULES FOR OPENING

Composición:

HYDROCORTISONE 0.5 MG

Vía de administración:

PER OS

tipo de receta:

Required

Fabricat per:

DIURNAL EUROPE B.V., THE NETHERLANDS

Área terapéutica:

HYDROCORTISONE

indicaciones terapéuticas:

Alkindi is indicated for replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old)

Data d'autorització:

2020-05-03

Informació per a l'usuari

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
ALKINDI 0.5 MG
ALKINDI 1 MG
ALKINDI 2 MG
ALKINDI 5 MG
GRANULES IN CAPSULE FOR OPENING
ACTIVE INGREDIENT:
Each capsule for opening contains 0.5 mg, 1 mg, 2 mg or 5 mg of
hydrocortisone, respectively.
INACTIVE INGREDIENTS AND ALLERGENS IN THE MEDICINAL PRODUCT: See
section 2, ‘Important information
about some of this medicine’s ingredients’ and section 6,
‘Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult with your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
IMPORTANT!
ALKINDI GRANULES ARE MARKETED IN CAPSULES.
OPEN THE CAPSULE, EMPTY IT AND USE THE CONTENTS ONLY
ACCORDING TO THE INSTRUCTIONS IN THIS LEAFLET. SEE SECTION 3.
DISCARD THE EMPTY CAPSULE AND PREVENT ACCESS TO IT BY
CHILDREN.
SWALLOWING THE CAPSULE MAY CAUSE CHOKING.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Alkindi is intended as a replacement hormone therapy in instances of
adrenal gland insufficiency in
infants, children and adolescents (from birth up to 18 years of age).
THERAPEUTIC GROUP – the medicine belongs to the group of
corticosteroids for systemic use –
glucocorticoids.
Alkindi contains a substance called hydrocortisone, an alternative
version of cortisol, which is the
natural hormone released into the body by the adrenal glands. When
these glands are not fully
functioning, the amount of cortisol secreted is reduced. Alkindi
constitutes a replacement for the
natural hormone.
2. BEFORE USING THIS MEDICINE
Do not use this medicine:

if you/your child are sensitive (allergic) to the active ingredient
(hydrocortisone) or to any of the
other ingredients of this medicine listed in sectio

Fitxa tècnica

1
1.
NAME OF THE MEDICINAL PRODUCT
Alkindi 0.5 mg
Alkindi 1 mg
Alkindi 2 mg
Alkindi 5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alkindi 0.5 mg granules in capsules for opening Each capsule contains
0.5 mg hydrocortisone
Alkindi 1 mg granules in capsules for opening Each capsule contains 1
mg hydrocortisone
Alkindi 2 mg granules in capsules for opening Each capsule contains 2
mg hydrocortisone
Alkindi 5 mg granules in capsules for opening Each capsule contains 5
mg hydrocortisone
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules in capsules for opening.
The granules are white to off-white and contained in a transparent
colourless (size 00el) hard capsule.
Alkindi 0.5 mg granules in capsules for opening
The capsule is printed with "INF-0.5" in red ink.
Alkindi 1 mg granules in capsules for opening
The capsule is printed with "INF-1.0" in blue ink.
Alkindi 2 mg granules in capsules for opening
The capsule is printed with "INF-2.0" in green ink.
Alkindi 5 mg granules in capsules for opening
The capsule is printed with "INF-5.0" in grey ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alkindi is indicated for
replacement therapy of adrenal insufficiency in infants, children and
adolescents (from birth to < 18 years old).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage must be individualised according to the response of the
individual patient. The lowest
possible dosage should be used.
2
Monitoring of the clinical response is necessary and patients should
be observed closely for signs
that might require dosage adjustment, including changes in clinical
status resulting from remissions
or exacerbations of the disease, individual responsiveness to the
medicinal product, and the effect of
stress (e.g. surgery, infection, trauma). During stress it may be
necessary to increase the dose
temporarily.
_Replacement therapy in primary and secondary adrenal insufficiency _
Alkindi is given as replacement therapy by oral administration of
granules according to
clinical practice