Ilomedin

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Iloprost trometamol 134 µg/mL equivalent to 100 µg Iloprost/mL;  ;  

Disponível em:

Bayer New Zealand Limited

DCI (Denominação Comum Internacional):

Iloprost trometamol 134 µg/mL (equiv. 100 µg Iloprost/mL)

Dosagem:

50 mcg/0.5mL

Forma farmacêutica:

Solution for infusion

Composição:

Active: Iloprost trometamol 134 µg/mL equivalent to 100 µg Iloprost/mL     Excipient: Ethanol Hydrochloric acid Sodium chloride Trometamol Water for injection

Unidades em pacote:

Ampoule, 0.5ml, 5 dose units

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Bayer AG

Indicações terapêuticas:

Treatment of patients with severe peripheral arterial occlusive disease (PAOD) particularly those at risk of amputation and in whom surgery or angioplasty is not possible.

Resumo do produto:

Package - Contents - Shelf Life: Ampoule, 0.5ml - 5 dose units - 48 months from date of manufacture stored at or below 30°C

Data de autorização:

1990-04-27

Folheto informativo - Bula

ILOMEDIN
®
 CMI 

1 
CONSUMER MEDICINE INFORMATION 

ILOMEDIN
®

(I·LOM·ED·IN)

_iloprost (as trometamol) _

WHAT IS IN THIS LEAFLET 
This leaflet answers some common
questions about Ilomedin. It does not contain all 
the available information. It does not take the place
of talking to your doctor, nurse or 
pharmacist.  

All medicines have risks and benefits. Your doctor has weighed
the risks of you 
taking Ilomedin against the benefits they expect it will have
for you. 

IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR, NURSE OR 
PHARMACIST. 

KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read
it again. 

WHAT IS ILOMEDIN USED FOR AND HOW DOES IT WORK? 
Ilomedin contains the active substance
iloprost (as trometamol), which mimics the 
action of a natural substance known
as prostacyclin. Prostacyclin prevents 
inflammation, inhibits unwanted build up of platelets and
widens blood vessels. 

Ilomedin promotes the healing of ulcerations secondary to
ischaemia (decreased 
blood supply) and lessens the pain in
severe, long lasting disturbances of arterial 
circulation. 
Ilomedin also widens narrow blood vessels in the lung, which in
turn allows the heart 
to function more effectively.  

It is used for the treatment of: 
- 
Severe peripheral arterial occlusive disease (PAOD), where
the blood vessels in 
the arms and legs either become blocked or narrowed. 
- 
Advanced Buerger's disease - insufficient blood flow to the
hands and feet 
causing swelling and clotting of the blood vessels.  
- 
Severe disabling Raynaud's phenomenon - discolouration of the
fingers, toes, 
and occasionally other areas - which is unresponsive to
other therapies. 
- 
Moderate or severe
stages of pulmonary hypertension. Pulmonary hypertension 
is a condition where blood pressure i

Características técnicas

191205 Ilomedin Data sheet
Page 1 of 13
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ILOMEDIN® 50 microgram/0.5 mL Solution for Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ILOMEDIN 0.5 mL aqueous solution contains iloprost trometamol 67
micrograms (equivalent to
iloprost 50 micrograms)
3
PHARMACEUTICAL FORM
Clear, colourless, sterile pyrogen-free solution for infusion.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of patients with severe peripheral arterial occlusive
disease (PAOD), particularly those at
risk of amputation and in whom surgery or angioplasty is not possible.
Treatment of advanced thromboangiitis obliterans (Buerger's disease)
with critical limb ischaemia in
cases where revascularisation is not indicated.
Treatment of patients with severe disabling Raynaud's phenomenon
unresponsive to other
therapies.
Treatment of moderate or severe primary and secondary pulmonary
hypertension such as New York
Heart Association functional classes III and IV.
4.2
Dose and method of administration
ILOMEDIN should be used only under strict monitoring in hospitals or
out-patient clinics with
adequate facilities.
Pregnancy must be excluded before the start of treatment in women.
ILOMEDIN is administered after dilution as an intravenous infusion
over 6 hours daily via a
peripheral vein or a central venous catheter. The dose is adjusted
according to individual tolerability
within the range of 0.5 to 2.0 ng iloprost/kg body weight/min.
The infusion solution should be made up freshly each day to ensure
sterility.
The contents of the ampoule and the diluent should be mixed
thoroughly.
The blood pressure and heart rate must be measured at the start of the
infusion and after every
increase of the dose.
During the first 2 - 3 days, the individually tolerated dose is
established. For this purpose, treatment
should be started at an infusion rate to deliver 0.5 ng/kg/min. for 30
minutes. The dose should then
be increased at intervals of about 30 minutes in steps of 0.5
ng/kg/min. up to 2.0 ng/kg/min. The
exact inf