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SPC: CAELYX Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Caelyx 2 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

One ml of Caelyx contains 2 mg doxorubicin hydrochloride in a pegylated liposomal formulation. Caelyx, a liposome formulation, is doxorubicin hydrochloride encapsulated in liposomes with surface-bound ...

Pharmaceutical form

Concentrate for solution for infusion. The suspension is sterile, translucent and red.

Therapeutic indications

Caelyx is indicated: As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. For treatment of advanced ovarian cancer in women who have failed a first-line ...

Posology and method of administration

Caelyx should only be administered under the supervision of a qualified oncologist specialised in the administration of cytotoxic agents. Caelyx exhibits unique pharmacokinetic properties and must not ...

Contraindications

Hypersensitivity to the active substance, peanut or soya, or to any of the excipients listed in section 6.1. Caelyx must not be used to treat AIDS-KS that may be treated effectively with local therapy ...

Special warnings and precautions for use

Given the difference in pharmacokinetic profiles and dosing schedules, Caelyx should not be used interchangeably with other formulations of doxorubicin hydrochloride. Cardiac toxicity It is recommended ...

Interaction with other medicinal products and other forms of interaction

No formal medicinal product interaction studies have been performed with Caelyx, although phase II combination trials with conventional chemotherapy agents have been conducted in patients with gynaecological ...

Fertility, pregnancy and lactation

Pregnancy Doxorubicin hydrochloride is suspected to cause serious birth defects when administered during pregnancy. Therefore, Caelyx should not be used during pregnancy unless clearly necessary. Women ...

Effects on ability to drive and use machines

Caelyx has no or negligible influence on the ability to drive and use machines. However, in clinical studies to date, dizziness and somnolence were associated infrequently (<5%) with the administration ...

Undesirable effects

Summary of the safety profile The most common undesirable effect reported in breast/ovarian clinical trials (50 mg/m² every 4 weeks) was palmar-plantar erythrodysesthesia (PPE). The overall incidence of ...

Overdose

Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and thrombocytopaenia. Treatment of acute overdose of the severely myelosuppressed patient consists of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cytotoxic agents (anthracyclines and related substances) ATC code: L01DB01 Mechanism of action The active ingredient of Caelyx is doxorubicin hydrochloride, a cytotoxic anthracycline ...

Pharmacokinetic properties

Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride. Pegylated liposomes contain surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol (MPEG). ...

Preclinical safety data

In repeat dose studies conducted in animals, the toxicity profile of Caelyx appears very similar to that reported in humans who receive long-term infusions of standard doxorubicin hydrochloride. With Caelyx, ...

List of excipients

α-(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)--methoxypoly(oxyethylen)-40 sodium salt (MPEG-DSPE) Fully hydrogenated soy phosphatidylcholine (HSPC) Cholesterol Ammonium sulphate Sucrose ...

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life: 20 months. After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately. ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. For storage conditions of the diluted medicinal product, see section 6.3.

Nature and contents of container

Type I glass vials, each with a siliconised grey bromobutyl stopper, and an aluminium seal, with a deliverable volume of 10 ml (20 mg) or 25 ml (50 mg). Caelyx is supplied as a single pack or packs of ...

Special precautions for disposal and other handling

Do not use material that shows evidence of precipitation or any other particulate matter. Caution must be exercised in handling Caelyx solution. The use of gloves is required. If Caelyx comes into contact ...

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization number(s)

EU/1/96/011/001 EU/1/96/011/002 EU/1/96/011/003 EU/1/96/011/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 June 1996 Date of lastest renewal: 19 May 2006

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