AMSIDINE 50 Mg/Ml Concentrate and solvent for solution for infusion

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

AMSACRINE

Доступна з:

NordMedica A/S

Код атс:

L01XX01

ІПН (Міжнародна Ім'я):

AMSACRINE

Дозування:

50 Mg/Ml

Фармацевтична форма:

Concentrate and solvent for solution for infusion

Тип рецепту:

Product subject to prescription which may not be renewed (A)

Терапевтична области:

Other antineoplastic agents

Статус Авторизація:

Authorised

Дата Авторизація:

2012-08-17

інформаційний буклет

AMSA IE  PIL Feb2016 
1

PATIENT INFORMATION LEAFLET 
AMSIDINE 50 MG/ML INJECTION 
Amsacrine Concentrate for Infusion 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 
THIS MEDICINE. 

Keep this leaflet. You may need to read it again. 
If you have any further questions, ask your doctor
or pharmacist. 
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 

In this leaflet: 
1. What Amsidine Injection is and what it is used for 
2. Before you are given Amsidine Injection 
3. How Amsidine Injection is given 
4. Possible side effects 
5. How to store Amsidine Injection 
6. Further information 

1. WHAT AMSIDINE INJECTION IS AND WHAT IT IS USED FOR 
Amsidine Injection is one of a group of medicines called
antineoplastic (anticancer) agents. 

It is used to treat acute leukaemia, a form of cancer
of the white cells in your blood. 

2. BEFORE YOU RECEIVE AMSIDINE INJECTION 

YOU SHOULD NOT BE GIVEN AMSIDINE INJECTION IF: 
•  You  know  that  you  are  allergic  to  amsacrine  or  to  any  of  the  other  ingredients  (see  section  6  of  this 
leaflet) 
•  You  are  already  receiving  other  treatments  for  cancer,  including  radiation,  which  have  affected  your 
bone marrow or you have received treatments in the past (your
doctor will advise you) 
• You are under 12 years old. 
• You are breast feeding 

Speak to your doctor _before _you are given this injection
if any of these apply to you. 

BEFORE YOU ARE GIVEN AMSIDINE INJECTION, YOUR DOCTOR WILL TAKE SPECIAL CARE IF ANY OF THE FOLLOWING 
SITUATIONS  APPLY  TO  YOU.  MAKE  SURE  YOUR  DOCTOR  IS  AWARE  OF  THESE  SITUATIONS  IF  IT  IS  NOT  ALREADY 
OBVIOUS: 

• You hav

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amsidine 50mg/ml Concentrate and Solvent for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 75mg amsacrine in 1.5ml (50mg per ml).
Each solvent vial contains 13.5ml of Lactic Acid and water for
injection to give a concentration of 0.0353M L-Lactic
acid.
Each ml of the combined solution of the concentrate when diluted with
the solvent contains 5mg amsacrine per ml
For a full list of exipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate and solvent for solution for Infusion.
Concentrate is a clear, bright orange/red coloured solution and
solvent for infusion is clear colourless solution.
The pH of the combined solution is 3.5 - 4.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amsidine is indicated for the induction and maintenance of remission
in acute leukaemia of adults. It is effective in
patients refractory to the anthracycline antibiotics used singly or in
combination with other chemotherapeutic agents,
and in patients who were formerly treated with maximum cumulative
doses of these antibiotics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous infusion
Amsidine must be diluted in 500ml 5% Dextrose Injection BP and infused
over 60 to 90 minutes. Phlebitis or pain at
the injection site may occur at doses greater than 70 mg/m
2
. (NOTE: DO NOT USE OTHER DILUENTS. AMSIDINE
IS INCOMPATIBLE WITH SALINE). Care must be taken that no extravasation
occurs which might produce severe
irritation or
necrosis. Caution in the handling and preparation of
the solution should be exercised,
and the use of
polyethylene gloves is recommended. If the solution of Amsidine
contacts the skin or mucosae,
immediately wash
thoroughly with soap and water.
Adults
Induction of remission phase
The usual dosage of Amsidine in the induction phase is 90mg/m
2
every day for five consecutive days (total dose 450
mg/m
2
per course of treatment).
If bone marrow biopsy performed on day six displays over 50%
cellularity and the
b