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CAMPTO Concentrate for solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CAMPTO 20 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

The concentrate contains 20 mg/ml irinotecan hydrochloride, trihydrate (equivalent to 17.33 mg/ml irinotecan). One vial of 2 ml contains 34.66 mg of irinotecan as 40 mg of irinotecan hydrochloride, trihydrate ...

Pharmaceutical form

Concentrate for solution for infusion.

Therapeutic indications

CAMPTO is indicated for the treatment of patients with advanced colorectal cancer: in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease, as a ...

Posology and method of administration

Posology For adults only. CAMPTO solution for infusion should be infused into a peripheral or central vein. Recommended dosage In monotherapy (for previously treated patient): The recommended dosage of ...

Contraindications

Chronic inflammatory bowel disease and/or bowel obstruction (see section 4.4). Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Lactation (see section 4.6). ...

Special warnings and precautions for use

The use of CAMPTO should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of ...

Interaction with other medicinal products and other forms of interaction

Concomitant use contraindicated (see section 4.3) Yellow fever vaccine: Risk of fatal generalised reaction to vaccines Saint Johns Wort: Decrease in the active metabolite of irinotecan, SN-38, plasma levels. ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women of childbearing potential and men have to use effective contraception during and up to 1 month and 3 months after treatment respectively. ...

Effects on ability to drive and use machines

CAMPTO has moderate influence on the ability to drive and use machines. Patients should be warned about the potential for dizziness or visual disturbances which may occur within 24 hours following the ...

Undesirable effects

Clinical studies Adverse reaction data have been extensively collected from studies in metastatic colorectal cancer; the frequencies are presented below. The adverse reactions for other indications are ...

Overdose

Symptoms There have been reports of overdosage at doses up to approximately twice the recommended therapeutic dose, which may be fatal. The most significant adverse reactions reported were severe neutropenia ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cytostatic topoisomerase I inhibitor ATC Code: L01XX19 Mechanism of action Experimental data Irinotecan is a semi-synthetic derivative of camptothecin. It is an antineoplastic ...

Pharmacokinetic properties

Absorption At the end of the infusion, at the recommended dose of 350 mg/m², the mean peak plasma concentrations of irinotecan and SN-38 were 7.7 µg/ml and 56 ng/ml, respectively, and the mean area under ...

Preclinical safety data

Irinotecan and SN-38 have been shown to be mutagenic in vitro in the chromosomal aberration test on CHO-cells as well as in the in vivo micronucleus test in mice. However, they have been shown to be devoid ...

List of excipients

Sorbitol E420 Lactic acid Sodium hydroxide (to adjust to pH 3.5) hydrochloride acid (for pH adjustment) Water for injections

Incompatibilities

None known. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life The shelf life of unopened vials is 24 months (40 mg in 2 mL presentation) or 36 months (100 mg in 5 mL and 300 mg in 15 mL presentations). CAMPTO solution is physically and chemically stable ...

Special precautions for storage

For storage conditions after dilution of the medicinal product, see section 6.3. Store below 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Single amber-coloured medical-grade polypropylene vial closed with halobutyl rubber stopper. Vials contain 40 mg/2 ml; 100 mg/5ml or 300 mg/15 ml of solution. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

As with other antineoplastic agents, CAMPTO must be prepared and handled with caution. The use of glasses, mask and gloves is required. If CAMPTO solution or infusion solution should come into contact ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/0627

Date of first authorization / renewal of the authorization

Date of first authorisation: 05 May 1995 Date of latest renewal: 26 August 2014

Date of revision of the text

05/2018

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