Gemcitabine Strides 38mg/mL Powder for Solution for Infusion (50ml)

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

GEMCITABINE

Διαθέσιμο από:

Strides Arcolab International Limited Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD 189 SS, United Kingdom

Φαρμακολογική κατηγορία (ATC):

L01BC05

INN (Διεθνής Όνομα):

GEMCITABINE 38 mg/ml

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION FOR INFUSION

Σύνθεση:

GEMCITABINE 38 mg/ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2014-03-05

Φύλλο οδηγιών χρήσης

460 x 180 mm - Front and Back side printing
Page 1 of 2
Front side printing
THE FOLLOWING INFORMATION IS INTENDED FOR 
MEDICAL OR HEALTHCARE PROFESSIONALS ONLY: 
INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL. 

1.  Use aseptic techniques during the 
reconstitution and any further dilution of 
gemcitabine for intravenous infusion 
administration. 

2.  Calculate the dose and the number of 
Gemcitabine Strides vials needed. 

3.  Reconstitute 200 mg vials with 5 ml of 
9 mg/ml (0.9 %) sterile sodium 
chloride solution for injection, without 
preservative, or 25 ml sterile sodium 
chloride solution for injection, without 
preservative to the 1000 mg vial. Shake 
to dissolve. The total volume after 
reconstitution is 5.26 ml (200 mg vial) 
or 26.3 ml (1000 mg vial) respectively. 
This dilution yields a gemcitabine 
concentration of 38 mg/ml, which 
includes accounting for the displacement 
volume of the lyophilised powder. 
Further dilution with sterile sodium 
chloride 9 mg/ml (0.9%) solution for 
injection, without preservative may be 
done. The resulting solution is clear and 
ranges in colour from colourless to light 
straw-coloured. 

4.  Parenteral medicinal products should be 
inspected visually for particulate matter 
and discolouration prior to administration. 
If particulate matter is observed, do not 
administer. 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
GEMCITABINE STRIDES 38 MG/ML 
POWDER FOR SOLUTION FOR INFUSION 
GEMCITABINE 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
RECEIVING THIS 
MEDICINE. 
-  Keep this leaflet. You may need to read it again. 
-  If you
have further questions, please ask your doctor, nurse or 
pharmacist. 
-  This medicine has been prescribed for you.
Do not pass it on to 
others. It may harm them, even if their symptoms are the
same 
as yours. 
-  If any of the sid

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Epirubicin hydrochloride 2 mg/ml Solution for Injection or
Infusion 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each ml of solution for injection or infusion contains 2 mg of
epirubicin hydrochloride. 

Each vial of 5 ml contains 10 mg of epirubicin hydrochloride. 
Each vial of 25 ml contains 50 mg of epirubicin hydrochloride. 
Each vial of 50 ml contains 100 mg of epirubicin hydrochloride. 
Each vial of 100 ml contains 200 mg of epirubicin hydrochloride. 

Excipient (S): 
1 ml of solution for injection or infusion contains
3.5 mg sodium. 
- 1 vial of 5 ml solution contains 17.7 mg sodium. 
- 1 vial of 25 ml solution contains 88.5 mg sodium. 
- 1 vial of 50 ml solution contains 177.0 mg sodium. 
- 1vial of 100 ml solution contains 354.1  mg sodium. 

For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Solution for Injection or Infusion. 

A red solution 
4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Epirubicin is used in the treatment of a range of neoplastic
conditions including; 
•  
Carcinoma of the breast 
•  
Gastric cancer 

When administered intravesically, epirubicin has been shown to be
beneficial in the treatment of: 
•  
Papillary transitional cell carcinoma of the bladder 
• 
Carcinoma-in-situ of the bladder 
• 
Intravesical prophylaxis of recurrences of superficial bladder
carcinoma following 
 transurethral 
resection. 

For intravesical use a positive benefit-risk ratio could only be
established in patients in whom live 
attenuated BCG is contra-indicated or inappropriate. 

Epirubicin hydrochloride 2 mg/ml can be used in polychemotherapy
schedules. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Epirubicin is for intravenous and intravesical use only. 

Intravenous administration: 

It is advisable to give the drug via the tubing of a freely running
I.V.