GHRYVELIN (previously Macimorelin Aeterna Zentaris)

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

macimorelin acetate

Dostupné z:

Atnahs Pharma Netherlands B.V.

ATC kód:

V04CD06

INN (Medzinárodný Name):

macimorelin

Terapeutické skupiny:

macimorelin

Terapeutické oblasti:

Diagnostic Techniques, Endocrine

Terapeutické indikácie:

This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.

Prehľad produktov:

Revision: 3

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2019-01-11

Príbalový leták

17
B.
PACKAGE LEAFLET
18
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT/USER
GHRYVELIN
®
60 MG GRANULES FOR ORAL SUSPENSION IN SACHET
macimorelin
This medicine is subject to additional monitoring. This will allow
quick identification of new safety information. You can help by
reporting any side
effects you may get. See the end of section 4 for how to report side
effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU TAKE 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 nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What GHRYVELIN is and what it is used for
2.
What you need to know before GHRYVELIN is given
3.
How GHRYVELIN is given
4.
Possible side effects
5.
How GHRYVELIN is stored
6.
Contents of the pack and other information
1.
WHAT GHRYVELIN IS AND WHAT IT IS USED FOR
The medicine contains an active substance called macimorelin.
Macimorelin acts like a natural hormone and causes the pituitary gland
to release growth
hormone into the blood stream.
GHRYVE
LIN is used in adults to test the body´s ability to produce growth
hormone. It is used when your doctor thinks that you may not have
enough growth
hormone (adult growth hormone deficiency). This is not a treatment for
patients who do not have enough growth hormone. It is a test that
helps your doctor to
diagnose this condition.
2.
WHAT YOU NEED TO KNOW BEFORE GHRYVELIN IS GIVEN
YOU MUST NOT BE GIVEN GHRYVELIN
•
if you are allergic to macimorelin or any of the other ingredients of
this medicine (listed in section 6).
If you are not sure, talk to your doctor or nurse before you are given
GHRYVELIN.
WARNINGS AND PRECAUTIONS
To ensure that the test results

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are
asked to report any suspected adverse reactions. See section 4.8 for
how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
GHRYVELIN 60 mg granules for oral suspension in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 60 mg macimorelin (as acetate). 1 mL of the
reconstituted suspension contains 500 micrograms macimorelin.
Excipient(s) with known effect
Contains lactose monohydrate 1,691.8 mg per sachet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral suspension in sachet.
White to off-white granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
GHRYVELIN is indicated for the diagnosis of growth hormone deficiency
(GHD) in adults (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The use of GHRYVELIN must be supervised by a physician or healthcare
professional experienced in diagnosing growth hormone deficiency.
Posology
_Adult population _
The dose is calculated based on the patient´s body weight. The
recommended single dose of the reconstituted suspension is 500
micrograms macimorelin per
kg body weight.
The growth hormone release is to be evaluated with three blood samples
collected at 45, 60 and 90 minutes after the administration of the
medicinal product.
_Discontinuation of therapy with growth hormone (GH) or medicinal
products directly affecting the pituitary secretion of somatotropin _
Patients on replacement therapy with growth hormone (GH, somatotropin)
or on medicinal products directly affecting the pituitary secretion of
somatotropin
(e.g. somatostatin analogues, clonidine, levopoda and dopamine
agonists) should be advised to discontinue such treatment at least 1
month before receiving
macimorelin. These substances could lead to unreliable GH stimulation
resul