Camptosar

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Irinotecan hydrochloride trihydrate 20 mg/mL;  ;  

Disponible depuis:

Pfizer New Zealand Limited

DCI (Dénomination commune internationale):

Irinotecan hydrochloride trihydrate 20 mg/mL

Dosage:

20 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Irinotecan hydrochloride trihydrate 20 mg/mL     Excipient: Hydrochloric acid Lactic acid Sodium hydroxide Sorbitol Water for injection

Unités en paquet:

Vial, glass, 2 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Olon SpA

Descriptif du produit:

Package - Contents - Shelf Life: Vial, glass, - 2 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, glass, - 5 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, plastic, Polypropylene - 2 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, plastic, Polypropylene - 5 mL - 36 months from date of manufacture stored at or below 30°C protect from light - Vial, plastic, Polypropylene - 15 mL - 36 months from date of manufacture stored at or below 30°C protect from light

Date de l'autorisation:

1996-08-30

Notice patient

CAMPTOSAR
®
1
CAMPTOSAR
®
_Irinotecan hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CAMPTOSAR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of treating you with
CAMPTOSAR against the expected
benefits it will have for you.
ASK YOUR DOCTOR IF YOU HAVE ANY
CONCERNS ABOUT BEING TREATED WITH
THIS MEDICINE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CAMPTOSAR IS
USED FOR
CAMPTOSAR is used to treat bowel
cancer which has spread to other
parts of the body. Cancer which has
spread cannot be treated by surgery
alone. One of the options in this
situation is treatment with an
anticancer medicine, known as
chemotherapy.
CAMPTOSAR may be used once
spread of cancer beyond the bowel is
first diagnosed. At this time
CAMPTOSAR will be given in
combination with other anticancer
medicines. Alternatively,
CAMPTOSAR is used alone when
the cancer has not responded or has
returned after initial treatment.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
CAMPTOSAR HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
_USE IN CHILDREN _
It is not known if CAMPTOSAR is
safe and effective in the treatment of
children.
BEFORE BEING TREATED
WITH CAMPTOSAR
_WHEN CAMPTOSAR MUST _
_NOT BE GIVEN _
CAMPTOSAR must not be given if
you:
are allergic to irinotecan
hydrochloride or any of the
ingredients listed at the end of
this leaflet
are or may become pregnant
are breastfeeding or intend to
breastfeed.
_BEFORE TREATMENT WITH _
_CAMPTOSAR _
You should be treated with
CAMPTOSAR by a doctor who is
experienced in treating patients with
cancer. Treatment will normally take
place in a hospital because of the
need for hospital facilities and skilled
personnel.
It is likely that your doctor will give
you one or more medicines before
administering CAMPTOSAR, to help
stop you vomiting or feelin

Résumé des caractéristiques du produit

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NEW ZEALAND DATA SHEET
1. PRODUCT NAME
CAMPTOSAR® Injection: Irinotecan hydrochloride injection 20 mg/mL.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of CAMPTOSAR Injection contains 20 mg irinotecan
hydrochloride.
Excipient(s) with known effects:

Sorbitol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
CAMPTOSAR injection is supplied as a sterile, light yellow or pale
yellow, clear, aqueous
solution with pH 3.5. It is intended for dilution with 5% Glucose
Injection or 0.9% Sodium
Chloride Injection prior to infusion.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CAMPTOSAR is indicated for the first line treatment of patients with
metastatic carcinoma
of the colon or rectum, in combination with 5FU/leucovorin. CAMPTOSAR
is also
indicated for patients with metastatic carcinoma of the colon or
rectum whose disease has
recurred or progressed following initial therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
It is recommended that patients receive premedication with antiemetic
agents. Prophylactic
or therapeutic administration of atropine should be considered in
patients experiencing
cholinergic symptoms (see section 4.4).
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COMBINATION AGENT THERAPY
DOSAGE REGIMENS
CAMPTOSAR injection in Combination with 5-Fluorouracil (5-FU) and
Leucovorin (LV)
CAMPTOSAR should be administered as an intravenous infusion over 90
minutes (see
Preparation of Infusion Solution). For all regimens, the dose of LV
should be administered
immediately after CAMPTOSAR, with the administration of 5-FU to follow
immediately
after the administration of LV. The recommended regimens are shown in
Table 1.
TABLE 1: COMBINATION AGENT DOSAGE REGIMENS AND DOSE MODIFICATIONS
A
REGIMEN 1
6 week cycle.
Treatment resumes Day 43
CAMPTOSAR
LV
5-FU
125 mg/m
2
IV over 90 min on Day 1, 8, 15, 22, then 2 wk rest
20 mg/m
2
IV bolus injection Day 1, 8, 15, 22, then 2 wk rest
500mg