Octreotide 50 micrograms/ml solution for injection

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

OCTREOTIDE

Доступно од:

Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire WA7 1NT, United Kingdom

АТЦ код:

H01CB02

INN (Међународно име):

OCTREOTIDE 50 µg/ml

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

OCTREOTIDE 50 µg/ml

Тип рецептора:

POM

Терапеутска област:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Статус ауторизације:

Withdrawn

Датум одобрења:

2013-03-13

Информативни летак

Page 1 of 10 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION 
OCTREOTIDE 100 MICROGRAMS/ML SOLUTION FOR INJECTION 
OCTREOTIDE 500 MICROGRAMS/ML SOLUTION FOR INJECTION 

OCTREOTIDE  

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. 
- 
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. This
includes any possible 
side effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET 
1. 
What Octreotide is and what it is used for 
2. 
What you need to know before you use Octreotide  
3. 
How to use Octreotide   
4. 
Possible side effects 
5. 
How to store Octreotide  
6. 
Contents of the pack and other information  

1. 
WHAT OCTREOTIDE IS AND WHAT IT IS USED FOR 

Octreotide is a hormone-containing medicinal product that inhibits the
secretion of other 
hormones, in a similar way to somatostatin, a hormone that occurs
naturally in the body. As a 
result, the symptoms of diseases in which hormones play a role can be
reduced or resolved. 

OCTREOTIDE IS USED: 
A. 
To treat excessive growth of bones and soft tissues, particularly of
the nose, lower jaw 
and ears, once puberty has passed. This condition is known
as ACROMEGALY. Excessive 
release of specific hormones cause acromegaly and in most cases, the
excessive 
hormone production is due to an enlargement of the pituitary gland
(adenoma of the 
pituitary gland). Symptoms include: an excessive increase in height,
tiredness, 
pigmented spots on the skin, joint pain and sweating. 
Octreotide can be helpful to treat patients with acromegaly who: 
  have no benefit from surgery or

Карактеристике производа

Page 1 of 14 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Octreotide 50 micrograms/ml solution for injection 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
One vial of 1 ml solution for injection contains octreotide acetate
equivalent to 50 
micrograms octreotide. 
For the full list of excipients, see section 6.1. 
3 PHARMACEUTICAL 
FORM 
Solution for injection. 
Clear, colourless to slightly brownish solution. 
pH of the solution: 3.9 – 4.5 
4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
• GEP 
tumours 
For the relief of symptoms associated with functional gastro
enteropancreatic endocrine 
tumours including: 

• 
carcinoid tumours with features of carcinoid syndrome 
• VIPomas 
• glucagonomas 

Octreotide is not an anticancer agent and is not curative in the
above-mentioned patients. 

• Acromegaly 
Symptomatic treatment and reduction of plasma levels of growth
hormone (GH) and IGF-1 
in patients with acromegaly who respond inadequately to treatment with
surgery or 
radiotherapy. Octreotide may also be administered to patients with
acromegaly who are not 
able or willing to undergo surgery, or in the initial stage of
radiotherapy treatment until it 
becomes effective. 

• 
Prevention of complications following pancreatic surgery. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
GEP tumours 
Initially 50 micrograms subcutaneously once or twice daily. 
Page 2 of 14 
Depending on the clinical response, the effect on the concentrations
of hormones produced 
by the tumour (in carcinoid tumours on the excretion of
5-hydroxy-indolacetic acid in urine) 
and on the tolerability, the dose may be gradually increased to 100
– 200 micrograms three 
times daily. In exceptional circumstances, higher doses may be
required. The maintenance 
doses should be determined individually. 
The recommended route of administration is subcutaneous. However, in
instances where a 
rapid response is required, e.g. carci