MYTOLAC lanreotide (as acetate) 120 mg solution for injection pre-filled syringe

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

lanreotide acetate, Quantity: 133.33 mg (Equivalent: lanreotide, Qty 120 mg)

Disponibbli minn:

Amdipharm Mercury Australia Pty Ltd

Għamla farmaċewtika:

Injection, solution

Kompożizzjoni:

Excipient Ingredients: water for injections; glacial acetic acid

Rotta amministrattiva:

Subcutaneous

Unitajiet fil-pakkett:

1 prefilled syringe delivering 120 mg lanreotide

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Mytolac is indicated for:,- the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory,- the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours,- the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.

Sommarju tal-prodott:

Visual Identification: Pre-filled syringe containing white to pale yellow semi-solid formulation, practically free of foreign particles; Container Type: Syringe; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2022-08-10

Fuljett ta 'informazzjoni

Mytolac®
1
MYTOLAC®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MYTOLAC?
Mytolac contains the active ingredient lanreotide (as acetate).
Mytolac is used for the:
•
treatment of acromegaly when the circulating levels of growth hormone
and IGF-1 remain abnormal after surgery and/or
radiotherapy, or in patients who do not respond to therapy with
medicines called dopamine agonists
•
treatment of symptoms associated with carcinoid syndrome, such as
flushing and diarrhoea
•
treatment and control of the growth of some advanced tumours of the
intestine and pancreas that cannot be removed by
surgery (called gastroenteropancreatic neuroendocrine tumours or
GEP-NETs) in adult patients.
For more information, see Section 1. Why am I using Mytolac? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MYTOLAC?
Do not use if you have ever had an allergic reaction to lanreotide,
somatostatin or medicines from the same family or any of
the ingredients listed at the end of the CMI. Do not use Mytolac if
you are breastfeeding.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Mytolac? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mytolac and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MYTOLAC?
•
Information on how to inject Mytolac can be found in the INSTRUCTIONS
FOR ADMINISTRATION OF THE PRODUCT at the end of this
leaflet.
•
For the treatment of acromegaly or the symptoms of carcinoid syndrome,
the recommended starting dose is 60 mg to
120 mg injected every 28 days.
•
For the treatment of advanced tumours of the intestine and pancreas
that cannot be removed by surgery (GE

Karatteristiċi tal-prodott

MYTOLAC
®
1
AUSTRALIAN PRODUCT INFORMATION
MYTOLAC
®
LANREOTIDE (AS ACETATE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Lanreotide acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanreotide (as acetate) 60 mg, 90 mg and 120 mg solution for injection
in a pre-filled
syringe.
Each
pre-filled
syringe
contains
a
supersaturated
solution
of
lanreotide
acetate
corresponding to 24.6 mg of lanreotide base per 100 mg of solution.
Each syringe delivers
an injection dose of 60 mg, 90 mg and 120 mg of lanreotide base,
respectively.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe.
It is a white to pale-yellow semi-solid formulation and is formulated
as a prolonged-release
solution of lanreotide acetate for deep subcutaneous injection.
Prolonged release of the
peptide is achieved by the physical nature of the supersaturated
solution.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mytolac is indicated for:
•
the treatment of acromegaly when the circulating levels of growth
hormone and
IGF-1 remain abnormal after surgery and/or radiotherapy or in patients
who are
dopamine agonist treatment refractory
•
the treatment of symptoms of carcinoid syndrome associated with
carcinoid tumours
•
the treatment of gastroenteropancreatic neuroendocrine tumours
(GEP-NETs) in
adult patients with unresectable locally advanced or metastatic
disease.
MYTOLAC
®
2
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
_Acromegaly: _
In patients receiving a somatostatin analogue for the first time, the
recommended starting
dose is 60 mg of lanreotide administered every 28 days.
In patients previously treated with lanreotide microparticle
formulation* once every 14 days,
the initial dose of Mytolac should be 60 mg every 28 days; in patients
previously treated
with lanreotide microparticle formulation once every 10 days, the
initial dose of Mytolac
should be 90 mg every 28 days, and in patients treated with lanreotide
microparticle
formulation once every 7 d