MACRILEN

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

MACIMORELIN AS ACETATE

Dostopno od:

MEGAPHARM LTD

Koda artikla:

V04CD06

Farmacevtska oblika:

GRANULES FOR SUSPENSION

Sestava:

MACIMORELIN AS ACETATE 60 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

AETERNA ZENTARIS GMBH,GERMANY

Terapevtsko območje:

MACIMORELIN

Terapevtske indikacije:

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

Datum dovoljenje:

2022-10-18

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a physician’s prescription only
Name of the medicine, its form and strength:
Macrilen
®
GRANULES FOR ORAL SUSPENSION
EACH SACHET CONTAINS:
MACIMORELIN )AS ACETATE( 60 MG
AFTER RECONSTITUTION: each 1 mL of reconstituted suspension contains
500
micrograms of macimorelin
Inactive and allergenic ingredients:
Each sachet contains 1,691.8 mg of lactose monohydrate.
See section 6 “Additional information” and section 2 “Important
information
about some of the medicine’s ingredients”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, consult your physician 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 illness is
similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Macrilen is intended for the diagnosis of growth hormone deficiency
)GHD(
in adults.
THERAPEUTIC GROUP: MACRILEN belongs to a group of medicines used to
diagnose and test pituitary gland activity.
The medicine contains an active ingredient called macimorelin, which
acts like
a natural hormone and causes the pituitary gland to release growth
hormone
into the bloodstream.
Macrilen is used in adults to test the body´s ability to produce
growth hormone.
Macrilen is used when your physician thinks that you may not have
enough
growth hormone )adult growth hormone deficiency(. Macrilen is not
intended
for the treatment of patients who do not have enough growth hormone.
Macrilen is a test that helps your physician to diagnose this
condition.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
●
You are sensitive )allergic( to the active ingredient, macimorelin, or
to any
of the additional ingredients contained in the medicine.
For a list of inactive ingredients, see section 6 “Additional
information”.
SPECIA

Lastnosti izdelka

1
1.
NAME OF THE MEDICINAL PRODUCT
MACRILEN
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.
MACRILEN 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 MACRILEN 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
results (see also section 4.4 and 4.5).
_ _
_Renal and/or hepatic impairment _
The safety and efficacy of macimorelin in patients with renal and/or
hepatic impairment have not been established (see also section 5.2).
No data are available.
If macimorelin is administered to patients with renal and/or hepatic
impairment, the potential for an increase