Gemcitabine Actavis 40mg/ml Concentrate for Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
24-06-2022
Summary of Product characteristics
(SPC)
24-06-2022
Active ingredient:
Gemcitabine
Available from:
Actavis Group hf
ATC code:
L01BC; L01BC05
INN (International Name):
Gemcitabine
Dosage:
40 milligram(s)/millilitre
Pharmaceutical form:
Concentrate for solution for infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Pyrimidine analogues; gemcitabine
Authorization status:
Marketed
Authorization date:
2016-03-04
Patient Information leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE ACTAVIS 40 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gemcitabine Actavis is and what it is used for
2.
What you need to know before you use Gemcitabine Actavis
3.
How to use Gemcitabine Actavis
4.
Possible side effects
5.
How to store Gemcitabine Actavis
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE ACTAVIS IS AND WHAT IT IS USED FOR
Gemcitabine Actavis belongs to a group of medicines called
“cytotoxics”. These medicines kill
dividing cells, including cancer cells.
Gemcitabine Actavis may be given alone or in combination with other
anti-cancer medicines,
depending on the type of cancer.
Gemcitabine Actavis is used in the treatment of the following types of
cancer:
-
Non-small cell lung cancer (NSCLC), alone or together with cisplatin
-
Pancreatic cancer.
-
Breast cancer, together with paclitaxel.
-
Ovarian cancer, together with carboplatin.
-
Bladder cancer, together with cisplatin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GEMCITABINE ACTAVIS
DO NOT USE GEMCITABINE ACTAVIS:
-
if you are allergic to gemcitabine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are breast-feeding
WARNINGS AND PRECAUTIONS
Before the first infusion you will have samples of your blood taken to
check if your liver and kidneys
are working well enough for you to receive this medicine. Before each
infusion you will have samples
of your blood taken to check if you have enough blood cells to receive
Gemcitabine Actavis. Your
doctor may decide to change the dose or delay treating you depend
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
23 June 2022
CRN00CYC8
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine Actavis 40mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 40 mg
gemcitabine (as gemcitabine hydrochloride).
Each 5 ml vial contains 200 mg gemcitabine (as gemcitabine
hydrochloride)
Each 25 ml vial contains 1 g gemcitabine (as gemcitabine
hydrochloride)
Each 50 ml vial contains 2 g gemcitabine (as gemcitabine
hydrochloride)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The pH of the concentrate is 2.4 ± 0.4 and the osmolarity is 270-280
mOsmol/kg.
Clear, colourless or pale yellow solution.
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 paclitaxel, is indicated for the
treatment of patients with unresectable, locally recurrent or
metastatic breast cancer who have relapsed following adjuvant /
neoadjuvant chemotherapy. Prior chemotherapy should have
included an anthracycline unless clinically contraindicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a
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