GEMCITABINE MEDAC 1500 MG

Israel - English - Ministry of Health

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Active ingredient:
GEMCITABINE AS HYDROCHLORIDE
Available from:
TZAMAL BIO-PHARMA LTD
ATC code:
L01BC05
Pharmaceutical form:
POWDER FOR SOLUTION FOR INFUSION
Composition:
GEMCITABINE AS HYDROCHLORIDE 1500 MG
Administration route:
I.V
Prescription type:
Required
Manufactured by:
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
Therapeutic group:
GEMCITABINE
Therapeutic area:
GEMCITABINE
Therapeutic indications:
Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locallyadvanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreaticcancer.Gemcitabine is indicated for the treatment of patients with bladder cancer at the invasive stage.Breast cancer:Gemcitabine in combination with paclitaxel is indicated for the treatment of patients with unresectable locallyrecurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy.Prior chemotherapy should have included an anthracycline unless clinically contraindicated.Ovarian cancer:Gemcitabine in combination with carboplatin is indicated for the treatment of patients with recurrent epithelialovarian carcinoma whom have relapsed at least six months after platinum - based therapy.
Authorization number:
143 62 32991 00
Authorization date:
2015-05-31

טסוגוא

2019

ה/דבכנ ת/חקור ,ה/אפור

:ןודנה

Gemcitabine medac 200 mg

ןיבטיצמג

קאדמ

ג"מ

Gemcitabine medac

ןיבטיצמג

קאדמ

ג"מ

Gemcitabine medac

ןיבטיצמג

קאדמ

ג"מ

ליעפ ביכרמ

Gemcitabine medac 200 mg: 200mg Gemcitabine

Gemcitabine medac 100 mg: 1000 mg Gemcitabine

Gemcitabine medac 150 mg: 1500 mg Gemcitabine

ןונימ תרוצ

Powder For Solution For Infusion

תויוותה תורשואמ

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 is indicated for the

treatment of patients with bladder cancer at the invasive stage.

Breast cancer: 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.

Ovarian cancer: Gemcitabine in combination with carboplatin is indicated for the

treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed

at least six months after platinum - based therapy.

תרבח מצ ויב ל

המראפ

מ"עב

תשקבמ

עידוהל םכ

לע

םינוכדע םיאבה ןולעב אפורל ה לש רישכת

תועצמאב תנמוסמ הרמחה

תחת וק

ש , ועמשמ הל רושקה עדימ תפסות איה ות הרמח

Posology and method of administration

Recommended posology:

Cisplatin has been used at doses between 75-100 mg/ m

once every 3 or 4 weeks

Paediatric population (<18 years)

Gemcitabine is not recommended for use in children under 18 years of age

due to insufficient data on safety and efficacy.

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, but other symptoms such as

headache, lethargy, confusion and blindness could also be present. Diagnosis

is optimally confirmed by magnetic resonance imaging (MRI). 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

Renal

Haemolytic uraemic syndrome

Clinical findings consistent with the haemolytic uraemic syndrome (HUS) were

rarely reported (post- marketing data) in patients receiving gemcitabine (see

section 4.8). HUS is a potentially life threatening disorder. Gemcitabine should

be discontinued at the first signs of any evidence of microangiopathic

haemolytic anaemia, such as rapidly falling haemoglobin with concomitant

thrombocytopenia, elevation of serum bilirubin, serum creatinine, blood urea

nitrogen, or LDH. Renal failure may not be reversible with discontinuation of

therapy and dialysis may be required.

ולעה

בה דרשמ רתאבש תופורתה רגאמב םוסרפל חלשנ רשואמה לבקל ןתינו תואיר ספדומ ו

ידי לע ,םושירה לעבל היינפ ויב למצ

המראפ

מ"עב :ןופלט ,

073-7151111

,הכרבב

ויב למצ

מ"עב המראפ

Combination use in ovarian cancer

Grade 3 and 4 Adverse Events

Carboplatin versus Gemcitabine plus carboplatin

Number

(%) of Patients

Carboplatin arm

Gemcitabine plus

174)

carboplatin arm

175)

Grade 3

Grade 4

Grade 3

Grade 4

Laboratory

Anaemia

10(5.7)

(2.3)

39 (22.3)

9 (5.1)

Neutropenia

(10.9)

(1.1)

73 (41.7)

50 (28.6)

Thrombocytopenia

(10.3)

(1.1)

53 (30.3)

8 (4.6)

Leucopenia

(6.3)

(0.6)

84 (48.0)

9 (5.1)

Non-laboratory

Haemorrhage

(0.0)

(0.0)

3 (1.8)

(0.0)

Febrile neutropenia

0 (0.0)

0 (0.0)

2 (1.1)

(0.0)

nfection without

(0.0)

(0.0)

1 (0.6)

neutropenia

Sensory neuropathy was also more frequent in the combination arm than with single agent

carboplatin.

Reporting suspected adverse reactions after authorization of the medicinal product is important.

lt allows continued monitoring of the benefiUrisk balance of the medicinal product .

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType

AdversEffectMedic@m

oh.health.gov.il.

4.9

Overdose

There is חס known antidote for overdose of gemcitabine. Doses as high as 5,700 mg/m

2

have

been administered by intravenous infusion over 30-minutes every 2 weeks with clinically

acceptable toxicity. ln the event of suspected overdose, the patient should be monitored with

appropriate blood counts and receive supportive therapy, as necessary.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Pyrimidine analogues ATC code: L01 BC05

Cytotoxic activity in cell cultures

Gemcitabine shows significant cytotoxic effects against a variety of cultured murine and human

tumour cells. lts action is phase-specific such that gemcitabine primarily kills cells that are

undergoing DNA synthesis (S-phase) and, under certain circumstances, blocks the progression

of cells at the junction of the G1/S phase boundary. ln vitro, the cytotoxic effect of gemcitabine is

dependent סח both concentration and time.

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