Myrelez 60 mg solution for injection in pre-filled syringe

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Lanreotide

Mevcut itibaren:

Amdipharm Limited

ATC kodu:

H01CB03

INN (International Adı):

Lanreotide

Doz:

60 milligram(s)

Farmasötik formu:

Solution for injection in pre-filled syringe

Terapötik alanı:

lanreotide

Yetkilendirme tarihi:

2021-07-23

Bilgilendirme broşürü

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYRELEZ® 60 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
MYRELEZ® 90 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
MYRELEZ® 120 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Lanreotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Myrelez® is and what it is used for
2.
What you need to know before you use Myrelez®
3.
How to use Myrelez®
4.
Possible side effects
5.
How to store Myrelez®
6.
Contents of the pack and other information
1.
WHAT MYRELEZ® IS AND WHAT IT IS USED FOR
Myrelez® contains the active substance lanreotide, which belongs to a
group of medicines called
“Antigrowth hormones”. It is similar to another substance (a
hormone) called “somatostatin”.
Lanreotide lowers the levels of hormones in the body such as growth
hormone (GH), and insulin-like
growth factor 1 (IGF-1) and inhibits the release of some hormones in
the gastrointestinal tract and
intestinal secretions. Additionally, it has an effect on some advanced
type of tumours (called
neuroendocrine tumours) of the intestine and pancreas by stopping or
delaying their growth.
WHAT MYRELEZ® IS USED FOR:
-
The treatment of acromegaly (a condition where your body produces too
much growth
hormone)
-
The relief of symptoms such as flushing and diarrhoea that sometimes
occur in patients with
neuroendocrine tumours (NETs)
-
The treatment and control of the growth of some advanced tumours of
the intestine and
pancreas called gastroenteropancr

Ürün özellikleri

Health Products Regulatory Authority
26 July 2021
CRN008YX6
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Myrelez 60 mg solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanreotide (I.N.N.), 60 mg (as acetate)
Each prefilled syringe contains a supersaturated solution of
lanreotide acetate corresponding to 0.246 mg lanreotide base/mg
of solution, which ensures an actual injection dose of 60 mg of
lanreotide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in a prefilled syringe.
White to pale yellow semi-solid formulation practically free of
foreign particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Myrelez is indicated for:
• The treatment of individuals with acromegaly when the circulating
levels of Growth Hormone (GH) and/or Insulin-like Growth
Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or
in patients who otherwise require medical treatment.
• The treatment of grade 1 and a subset of grade 2 (Ki67 index up to
10%) gastroenteropancreatic neuroendocrine tumours
(GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites
of origin have been excluded, in adult patients with
unresectable locally advanced or metastatic disease (see section 5.1).
• The treatment of symptoms associated with neuroendocrine
(particularly carcinoid) tumours.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ACROMEGALY
The recommended starting dose is 60 mg to 120 mg administered every 28
days.
The dose may be varied according to the patient's response (judged by
symptomatology and / or biochemical effect) or by the
patient's possible experience with somatostatin analogues.
For example, in patients previously treated with lanreotide 30 mg with
a dose every 14 days, the initial dose of Myrelez should
be 60 mg every 28 days, and in patients previously treated with
lanreotide 30 mg with a dose every 10 days, the initial dose of
Myrelez should be 90 mg every 28 days.
The dos