Lutrate Depot 22.5mg powder and solvent for prolonged-release suspension for injection

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

leuprorelin acetate

Available from:

GP-PHARM, S.A

ATC code:

L02AE02

INN (International Name):

leuprorelin acetate

Dosage:

22.5mg

Pharmaceutical form:

Powder and solvent for prolonged-release suspension for injection

Administration route:

intramuscular route

Units in package:

One (1) type I glass vial containing 22.5 mg

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

GP-PHARM, S.A

Therapeutic group:

Hormones and related agents. Gonadotropin-releasing hormones analogues

Therapeutic indications:

It is indicated for palliative treatment of hormone dependent advanced prostate cancer.

Authorization status:

Authorised

Authorization date:

2015-05-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

LUTRATE DEPOT 22.5 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION
FOR 
INJECTION 
leuprorelin acetate 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING 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. See section 4. 

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

1.  WHAT LUTRATE DEPOT IS AND WHAT IT IS USED FOR 
_ _
Lutrate Depot  is a vial containing a white
powder, which is made into a suspension for 
injection into a muscle. Lutrate Depot  contains the active ingredient leuprorelin (also called 
LEUPROLIDE), which belongs to a group of medicines called
luteinizing hormone releasing 
hormone (LHRH) agonists (medicines that reduce testosterone – a sex hormone).  

Your doctor has prescribed Lutrate Depot  for_  _palliative
treatment of advanced prostate 
cancer.  

2.  WHAT YOU NEED TO KNOW BEFORE YOU  USE LUTRATE DEPOT 

DO NOT USE LUTRATE DEPOT:  
- 
if  you are allergic (hypersensitive) to LHRH, LHRH
agonists or any of the other 
ingredients of this medicine  (listed  in  section  6). An allergic reaction may

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Lutrate Depot 22.5 mg powder and solvent for prolonged-release
suspension for 
injection 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vial contains 22.5 mg of leuprorelin acetate (equivalent to
21.42 mg leuprorelin 
free base). 
1 ml of reconstituted suspension contains 11.25 mg of leuprorelin
acetate. 
_Excipients with known effect: _
Each vial contains from 1.6 to 2.7 mg (<1 mmol) of sodium (as
carmellose sodium).  
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Powder and solvent for prolonged-release suspension for injection. 
Powder: white to off-white powder. 
Solvent: clear, colorless and particle free solution (pH 5.0 –
7.0). 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Lutrate Depot is indicated for palliative treatment of hormone
dependent advanced 
prostate cancer. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Posology 
The usual recommended dose of Lutrate Depot 22.5 mg presented
as a three months 
depot injection and administered as a
single intramuscular injection every three 
months. 

Lutrate Depot must be administered under direction of healthcare
professional having 
the appropriate expertise for monitoring the response
to treatment. 

The dose of Lutrate Depot 22.5 mg allowing the continuous release
of leuprorelin 
acetate over a three month period
is incorporated in a depot formulation. The 
lyophilized powder should be reconstituted and administered as
a single 
intramuscular injection every three months. Intraarterial
or intravenous administration 
must be avoided. The vial of Lutrate Depot
microsphere powder should be 
reconstituted immediately prior to administration by intramuscular
injection. As with 
other drugs administered regularly by injection, the injection
site should be varied 
periodically.