Alkindi
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
31-01-2024
Vara einkenni
(SPC)
31-01-2024
Opinber matsskýrsla
(PAR)
01-03-2018
Virkt innihaldsefni:
hydrocortisone
Fáanlegur frá:
Diurnal Europe B.V.
ATC númer:
H02AB09
INN (Alþjóðlegt nafn):
hydrocortisone
Meðferðarhópur:
Corticosteroids for systemic use
Lækningarsvæði:
Adrenal Insufficiency
Ábendingar:
Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Vörulýsing:
Revision: 8
Leyfisstaða:
Authorised
Leyfisdagur:
2018-02-09
Upplýsingar fylgiseðill
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALKINDI 0.5 MG GRANULES IN CAPSULES FOR OPENING
ALKINDI 1 MG GRANULES IN CAPSULES FOR OPENING
ALKINDI 2 MG GRANULES IN CAPSULES FOR OPENING
ALKINDI 5 MG GRANULES IN CAPSULES FOR OPENING
hydrocortisone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as those of the
child for whom this medicine has
been prescribed.
-
If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Alkindi is and what it is used for
2.
What you need to know before you give Alkindi
3.
How to give Alkindi
4.
Possible side effects
5.
How to store Alkindi
6.
Contents of the pack and other information
1.
WHAT ALKINDI IS AND WHAT IT IS USED FOR
Alkindi contains the active substance hydrocortisone. Hydrocortisone
belongs to a group of medicines
known as corticosteroids.
Hydrocortisone is a synthetic version of the natural hormone cortisol.
Cortisol is made by the adrenal
glands in the body. Alkindi is for use in children and adolescents
aged birth to 18 years when the body
is not making enough cortisol, because part of the adrenal gland is
not working (adrenal insufficiency,
often caused by an inherited condition called congenital adrenal
hyperplasia).
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE ALKINDI
DO NOT GIVE ALKINDI:
-
If your child is allergic to hydrocortisone or any of the other
ingredients of this medicine (listed
in section 6).
-
If your child has difficulties swallowing food, or is a premature baby
who cannot yet be fed by
mouth.
WARNING
Alkindi granules come in a
capsule that must be opened before use, dis
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Alkindi 0.5 mg granules in capsules for opening
Alkindi 1 mg granules in capsules for opening
Alkindi 2 mg granules in capsules for opening
Alkindi 5 mg granules in capsules for opening
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.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy of adrenal insufficiency in infants, children and
adolescents (from birth to
< 18 years old).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dose must be individualised according to the response of the
individual patient. The lowest possible
dose should be used.
Monitoring of the clinical response is necessary and patients should
be observed closely for signs that
might require dose 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 p
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