Somatuline LA 30mg powder and solvent for suspension for injection vials

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Lanreotide acetate

Inapatikana kutoka:

Ipsen Ltd

ATC kanuni:

H01CB03

INN (Jina la Kimataifa):

Lanreotide acetate

Kipimo:

30mg

Dawa fomu:

Powder and solvent for suspension for injection

Njia ya uendeshaji:

Intramuscular

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 08030403; GTIN: 5036611000004

Taarifa za kipeperushi

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMATULINE LA 30 MG, POWDER AND SOLVENT FOR PROLONGED RELEASE
SUSPENSION FOR INJECTION
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 or 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 or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Somatuline LA 30 mg is and what it is used for
2.
What you need to know before you use Somatuline LA 30 mg
3.
How to use Somatuline LA 30 mg
4.
Possible side effects
5.
How to store Somatuline LA 30 mg
6.
Contents of the pack and other information
1.
WHAT SOMATULINE LA 30 MG IS AND WHAT IT IS USED FOR
Somatuline LA 30 mg is a long acting formulation of lanreotide.
Lanreotide – the active substance – belongs to the group of
Antigrowth hormones. It is similar to the
naturally occurring hormone called somatostatin.
Lanreotide lowers the levels of hormones in the body such as GH
(Growth Hormone) and IGF-1
(Insulin-like Growth Factor-1) and inhibits the release of some
gastro-intestinal hormones and
intestinal secretions.
SOMATULINE LA 30 MG IS INDICATED FOR
•
The long-term treatment of acromegaly (a condition where too much
Growth Hormone is
produced)
•
The treatment of symptoms that occur with certain endocrine tumours of
the gastrointestinal tract
•
The treatment of primary thyrotropic adenomas (pituitary tumour
associated with
hyperthyroidism).
Page 2 of 9
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SOMATULINE LA 30 MG
DO NOT USE SOMATULINE LA 30 MG
•
If you are allergic (hypersensitive) to lanreotide, somatostatin and
drugs from the same family
(analogues of somatost

Tabia za bidhaa

OBJECT 1
SOMATULINE LA
Summary of Product Characteristics Updated 13-Jun-2016 | Ipsen Ltd
1. Name of the medicinal product
Somatuline LA 30 mg, powder for suspension for injection.
2. Qualitative and quantitative composition
Each vial contains 30 mg of lanreotide, presented as lanreotide
acetate.
After reconstitution with the solvent, 1 mL of suspension contains 15
mg lanreotide as lanreotide acetate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for suspension for injection.
Powder: a practically white friable cake.
4. Clinical particulars
4.1 Therapeutic indications
ACROMEGALY:
Somatuline LA is indicated for the treatment of 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.
THYROTROPIC ADENOMAS:
Somatuline LA is indicated for the treatment of thyrotropic adenomas
when the circulating level of
thyroid stimulating hormone remains inappropriately high after surgery
and/or radiotherapy.
NEUROENDOCRINE TUMOURS:
Somatuline LA is indicated for the relief of symptoms associated with
neuroendocrine (particularly
carcinoid) tumours.
4.2 Posology and method of administration
ACROMEGALY AND NEUROENDOCRINE TUMOURS:
Initially, one intramuscular injection should be given every 14 days.
The frequency of subsequent
injections may be varied in accordance with the individual patient's
response (as judged by a reduction in
symptoms and/or a reduction in GH and/or IGF-1 levels) such that
injections can be given every 7 to 10
days as necessary.
THYROTROPIC ADENOMAS:
Treatment should only be initiated and maintained by physicians
experienced in the management of this
condition.
Initially, one intra-muscular injection should be given every 14 days.
In the case of an insufficient
response, as judged by the levels of thyroid hormone and TSH, the
frequency of injection may be
increased to one every 10 days. Continued treatment should be guided
by periodic measurement of
thyroid hormone and TSH.
ELDERL