Octostim 15 micrograms/ml Solution for injection

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

DESMOPRESSIN ACETATE

Предлага се от:

Ferring Ireland Ltd

АТС код:

H01BA; H01BA02

INN (Международно Name):

DESMOPRESSIN ACETATE

дозиране:

15 microgram(s)/millilitre

Лекарствена форма:

Solution for injection

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Vasopressin and analogues; desmopressin

Статус Оторизация:

Not marketed

Дата Оторизация:

2006-04-28

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTOSTIM
® 15 MICROGRAMS/ML SOLUTION FOR INJECTION
Desmopressin acetate
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 Octostim Injection is and what it is used for
2. What you need to know before Octostim Injection is given
3. How Octostim Injection will be given
4. Possible side effects
5. How to store Octostim Injection
6. Contents of the pack and other information
1. WHAT OCTOSTIM INJECTION IS AND WHAT IT IS USED FOR
Octostim Injection is a clear, colourless solution. It contains
desmopressin acetate, an
antidiuretic (reduces urine production).
It is used:
•
during surgery or following trauma in patients with mild to moderate
haemophilia (blood
condition) or von Willebrand’s disease (blood clotting condition) to
increase blood clotting
factors Note: Octostim Injection is not suitable for every patient or
for the treatment of all
types of haemophilia or von Willebrand’s disease.
•
to test for fibrinolytic response (a test to measure the capacity of
the body to dissolve
blood clots once they have formed).
2. WHAT YOU NEED TO KNOW BEFORE OCTOSTIM INJECTION IS GIVEN
OCTOSTIM INJECTION WILL NOT BE GIVEN:
•
if you are allergic to desmopressin or any of the ingredients listed
in section 6
•
if you drink unusually large quantities of fluids, or if you
experience excessive thirst
•
if you are taking diuretics (water tablets)
•
if you suffer from angina or have heart problems
•
if you have type IIB von Willebrand’s disease
•
if you have low bl

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Octostim 15 micrograms/ml Solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 15 micrograms desmopressin
acetate equivalent to 13.4 micrograms
desmopressin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Uncoloured glass ampoule containing a clear aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OCTOSTIM
®
solution for subcutaneous injection or as intravenous infusion as
follows:
For short-term use to increase factor eight levels in patients with
mild to moderate haemophilia or von
Willebrand's disease under going surgery or following trauma, and who
respond positively to a test dose.
To test for Fibrinolytic response.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
0.3 micrograms/kg body weight subcutaneously or diluted in
physiological saline to 50-100 ml and given as an
intravenous infusion over 15-30 minutes. If a positive effect is
obtained, the initial OCTOSTIM dose may be
repeated 1-2 times with intervals of 6-12 hours. Further repetition of
the dose may result in a reduced effect.
In patients with haemophilia A the desired increase of VIII:C is
appraised by the same criterion as in the treatment
with Factor VIII-concentrate. If the OCTOSTIM infusion does not lead
to the desired increase of the concentration
of VIII:C in plasma, the treatment may be complemented with
administration of factor VIII concentrate. Treatment
of haemophilia patients should be conducted in consultation with each
patient’s coagulation laboratory.
Determination of coagulation factors and bleeding time before
OCTOSTIM-treatment:
Plasma levels of VIII:C and vWF:Ag increase substantially after the
desmopressin administration. However it has
not been possible to establish any correlation between the plasma
concentration of these factors and the bleeding
time, either before or after desmopressin. The effect of Desmopressin
on the bleeding time should therefore