GEMCITABINE TEVA CONCENTRATE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GEMCITABINE AS HYDROCHLORIDE

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L01BC05

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE AS HYDROCHLORIDE 40 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

ACTAVIS GROUP PTC EHF, ICELAND

Therapeutic group:

GEMCITABINE

Therapeutic area:

GEMCITABINE

Therapeutic indications:

GEMCITABINE TEVA® CONCENTRATE is indicated for the palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer.GEMCITABINE TEVA® CONCENTRATE is indicated for the treatment of patients with bladder cancer at the invasive stage.Breast cancer:GEMCITABINE TEVA® CONCENTRATE 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.Ovarian cancer:GEMCITABINE TEVA® CONCENTRATE in combination with carboplatin, is indicated for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed at least 6 months after platinum-based therapy.

Authorization date:

2018-10-31

Patient Information leaflet

העדוה
העדוה
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לע
הרמחה
הרמחה
(
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עדימ
עדימ
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ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
________
18
רבמבונ
2015
___
םש
רישכת
תילגנאב
רפסמו :םושירה
Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion
150.90.33868
םש
לעב
םושירה
קיבא :
קוויש .ד.ת ,מ"עב
8077
הינתנ ,
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL
WARNINGS AND
SPECIAL
PRECAUTIONS
FOR USE (4.4)
Posterior reversible encephalopathy syndrome
Reports of posterior reversible encephalopathy syndrome
(PRES) with potentially severe consequences have been
reported in patients receiving gemcitabine as single agent
or in combination with other chemotherapeutic agents.
Acute hypertension and seizure activity were reported in
most
gemcitabine
patients
experiencing
PRES.
Diagnosis is optimally confirmed by magnetic resonance
imaging. PRES was typically reversible with appropriate
supportive
measures.
Gemcitabine
should
be
permanently discontinued and supportive measures
implemented, including blood pressure control and anti-
seizure therapy, if PRES develops during therapy.
Capillary leak syndrome
Capillary leak syndrome has been reported in patients
receiving gemcitabine as single agent or in combination
with other chemotherapeutic agents (see section 4.8).
The condition is usually treatable if recognised early and
managed appropriately, but fatal cases have been
reported. The condition involves systemic capillary
hyperpermeability during which fluid and proteins from
the intravascular space leak into the interstitium. The
clinical features include generalised oedema, weight
gain, hypoalbuminaemia, severe hypotension, acute renal
impairment and pulmonary oedema. Gemcitabine should
be discontinued and supportive measures implemented if
capillary leak syndrome develops d

Summary of Product characteristics

Gemcitabine Teva Concentrate for Solution for Infusion Minor Updates,
04-2022, KL
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine Teva Concentrate
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 a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for IV infusion.
Clear, colourless or slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_Non-Small Cell Lung Cancer: _
Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion is
indicated for the
palliative treatment of patients with locally advanced or metastatic
non-small cell lung cancer.
_Breast Cancer: _
Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion 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.
_Pancreatic Cancer: _
Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion is
indicated for the
treatment of patients with locally advanced or metastatic
adenocarcinoma of the pancreas and
for patients with 5-FU refractory pancreatic cancer.
_Bladder Cancer: _
Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion is
indicated for the
treatment of patients with bladder cancer at the invasive stage.
_Ovarian Cancer: _
Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion in
combination with
carboplatin is indicated for the treatment of patients with recurrent
epithelial ovarian
carcinoma who have relapsed at least 6 months after platinum-based
therapy.
_ _
G