Gemcitabine Strides 38mg/mL Powder for Solution for Infusion (10ml)

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

GEMCITABINE

Tilgjengelig fra:

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

ATC-kode:

L01BC05

INN (International Name):

GEMCITABINE 38 mg/ml

Legemiddelform:

POWDER FOR SOLUTION FOR INFUSION

Sammensetning:

GEMCITABINE 38 mg/ml

Resept typen:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2014-03-05

Informasjon til brukeren

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

Preparatomtale

Page 1 of 17 

SUMMARY OF PRODUCT CHARACTERISTICS 

1.   
NAME OF THE MEDICINAL PRODUCT 

Gemcitabine Strides 38 mg/mL Powder for Solution for Infusion 

2.   
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One mL of reconstituted solution contains 38 mg gemcitabine, as
gemcitabine hydrochloride. 
One 200 mg vial contains 200 mg gemcitabine,
as gemcitabine hydrochloride for reconstitution in 5 
ml solvent. 
One 1000 mg vial contains 1000 mg gemcitabine, as gemcitabine
hydrochloride for reconstitution 
in 25 ml solvent. 

Excipients 
Each 200 mg vial contains 3.5 mg (<1 mmol) sodium. 

Each 1000 mg vial contains 17.5 mg (<1 mmol) sodium. 

For a full list of excipients, see section 6.1. 

3.   PHARMACEUTICAL 
FORM 

Powder for solution for infusion. 
White lyophilized powder or plug. 

The pH of the reconstituted solution in 0,9% sodium chloride is
between 2,7 and 3,3. 

The osmoloarity of the reconstituted solution (38 mg/ml gemcitabine
(as hydrochloride)) in 0,9% 
sodium chloride is between 706 and 765 mOsmol/kg. 

4.   CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Gemcitabine is indicated for the treatment of locally advanced
or metastatic bladder cancer in 
combination with cisplatin. 

Gemcitabine is indicated for treatment of patients with locally
advanced or metastatic 
adenocarcinoma of the pancreas. 

Gemcitabine, in combination with cisplatin is indicated as first line
treatment of patients with 
locally advanced or metastatic non-small cell lung cancer (NSCLC).
Gemcitabine monotherapy can 
be considered in elderly patients or those with performance status
2. 

Gemcitabine is indicated for the treatment of patients with locally
advanced or metastatic epithelial 
ovarian carcinoma, in combination with carboplatin, in patients with
relapsed disease following a 
recurrence-free interval of at least 6 months after platinum-based,
first-line therapy. 

Gemcitabine, in combination with pa