MITOMYCIN C 2 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MITOMYCIN C ( CRYSTALLINE )

Available from:

DEXCEL LTD, ISRAEL

ATC code:

L01DC03

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

MITOMYCIN C ( CRYSTALLINE ) 2 MG/VIAL

Administration route:

I.V, INTRA-PERITONEAL, INTRA-VESICALLY, INTRA-ARTERIAL, INTRAPLEURAL, INTRATHECAL

Prescription type:

Required

Manufactured by:

KYOWA HAKKO KIRIN CO. LTD., JAPAN

Therapeutic group:

MITOMYCIN

Therapeutic area:

MITOMYCIN

Therapeutic indications:

Remission of subjective and objective symptoms assocciated with the following diseases: Chronic lymphocytic leukemia, chronic myelocytic leukemia, gastric cancer, colorectal cancer, lung cancer, pancreatic cancer, liver cancer, cervix cancer, cancer of the endometrium, breast cancer, head and neck tumor and bladder tumor.

Authorization date:

2014-06-30

Summary of Product characteristics

EF No.147404
MIT-S
(
2
)(
10
)
イスラエル
1.
NAME OF THE MEDICINAL PRODUCT
MITOMYCIN C 2 MG
MITOMYCIN C 10 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of MITOMYCIN C contains Mitomycin C 2 mg or 10 mg
For the full list of excipients see Section 6.1
3.
PHARMACEUTICAL FORM
Injectable solution to be reconstituted before use
Blue-purple crystalline powder
Brand name
MITOMYCIN C 2mg
(2 mg potency/vial)
MITOMYCIN C 10mg
(10 mg potency/vial)
pH range
5.5 to 8.5
5.5 to 8.5
Osmotic
pressure ratio
Approx. 1 when
reconstituted with
5ml of distilled
water for injection
(JP)
Approx. 1 when
reconstituted with
25ml of distilled
water for injection
(JP)
Concentration
of sodium
chloride
0.96% when
reconstituted with
5ml of distilled water
for injection (JP)
0.96% when
reconstituted with
25ml of distilled
water for injection
(JP)
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Remission of subjective and objective symptoms associated with the
following diseases:
Chronic lymphocytic leukemia, chronic myelocytic leukemia, gastric
cancer,
colorectal cancer, lung cancer, pancreatic cancer, liver cancer,
cervix cancer,
cancer of endometrium, breast cancer, head and neck tumor and bladder
tumor.
4.2
Posology and method of administration
1) Intermittent administration
Usually for adults, 4 to 6mg (potency)/day of Mitomycin C is
administered
intravenously once or twice a week.
2) Administration on consecutive days
Usually for adults, 2mg (potency)/day of Mitomycin C is administered
intravenously every day.
3) Intermittent massive administration
Usually for adults, 10 to 30mg (potency)/day of Mitomycin C is
administered
intravenously every 1 to 3 weeks or at longer intervals.
4) Concurrent use with other antineoplastic agents
Usually for adults, 2 to 4mg (potency)/day of Mitomycin C is
administered
once or twice a week in combination with other antineoplastic agents.
Mitomycin C may be administered, if necessary, intraarterially,
intrathecally,
intrapleurally or intraperitoneally at a usual dose of 2 to 10mg
(potency)