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SPC: FOSCAN Solution for injection (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Foscan 1 mg/ml solution for injection.

Qualitative and quantitative composition

Each ml contains 1 mg of temoporfin. Excipients with known effect: Each ml contains 376 mg of ethanol anhydrous and 560 mg of propylene glycol. For the full list of excipients, see section 6.1

Pharmaceutical form

Solution for injection. Dark purple solution.

Therapeutic indications

Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy. ...

Posology and method of administration

Foscan photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Porphyria or other diseases exacerbated by light. Hypersensitivity to porphyrins. Tumours known to be eroding ...

Special warnings and precautions for use

All patients who receive Foscan will become temporarily photosensitive. Precautions must be taken to avoid exposure of skin and eyes to direct sunlight or bright indoor light during the first 15 days after ...

Interaction with other medicinal products and other forms of interaction

There is potential for exacerbation of skin photosensitivity if temoporfin is used with other photosensitising active substances. Such a reaction has been reported with topical 5-fluorouracil. No other ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of temoporfin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Foscan should not be used during pregnancy unless the clinical ...

Effects on ability to drive and use machines

The amount of alcohol in this medicinal product may impair the ability to drive or use machines. On the basis of the pharmacodynamic profile, temoporfin is presumed to be safe or unlikely to produce an ...

Undesirable effects

Summary of the safety profile All patients who receive Foscan will become temporarily photosensitive and must be instructed to observe precautions to avoid sunlight and bright indoor light. Regarding the ...

Overdose

In the event of an overdose, laser treatment would result in deeper tumour necrosis than would be expected with the recommended dose. Illumination of the tumour should only be carried out if the potential ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents ATC code: L01XD05 Temoporfin is a photosensitising agent used in the photodynamic therapy of tumours. The pharmacological activity ...

Pharmacokinetic properties

Temoporfin is a low clearance substance with a terminal plasma half-life of 65 hours in patients. Peak plasma levels occur at 2-4 hours post-injection thereafter plasma levels decline in a bi-exponential ...

Preclinical safety data

In repeated dose toxicity studies in rats and dogs, the main undesirable effects of temoporfin were phototoxicity and adverse injection site reactions. Local irritancy of Foscan solution for injection ...

List of excipients

Ethanol, anhydrous (E1510) Propylene glycol (E1520)

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Foscan must not be diluted with aqueous solutions.

Shelf life

Shelf life: 5 years. Once opened, the solution must be used immediately.

Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

Nature and contents of container

Type I amber glass vials with a bromobutyl elastomer stopper and aluminium seal containing either 1 ml or 3 ml or 6 ml of solution for injection. Each pack contains 1 vial and a filter with Luer lock connections ...

Special precautions for disposal and other handling

Appropriate precaution must be taken when handling this medicinal product. Studies have shown that Foscan is non-irritant. Each vial represents a single dose and any unused solution must be discarded. ...

Marketing authorization holder

biolitec Pharma Ltd., Otto-Schott-Str. 15, 07745, Jena, Germany

Marketing authorization number(s)

EU/1/01/197/003 EU/1/01/197/004 EU/1/01/197/005

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 October 2001 Date of latest renewal: 22 September 2011

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