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SPC, UK: GLIADEL Implant (2015)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Archimedes Pharma UK Ltd
Διεύθυνση :
250 South Oak Way, Green Park, Reading, RG2 6UG, UK
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Περιεχόμενα

Name of the medicinal product

GLIADEL 7.7 MG IMPLANT.

Qualitative and quantitative composition

Each implant contains 7.7 mg of carmustine. For a full list of excipients, see section 6.1.

Pharmaceutical form

Implant. Off-white to pale yellow flat discoid implant.

Therapeutic indications

GLIADEL Implant is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL Implant is indicated for use as an adjunct to surgery in patients with ...

Posology and method of administration

For intralesional use in adults only. Each GLIADEL Implant contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight implants are placed in the tumour resection cavity. It is recommended ...

Contraindications

Hypersensitivity to the active substance carmustine or to any of the excipients of GLIADEL Implant.

Special warnings and precautions for use

Patients undergoing craniotomy for glioblastoma and implantation of GLIADEL Implant should be monitored closely in view of known complications of craniotomy which includes convulsions, intracranial infections, ...

Interaction with other medicinal products and other forms of interaction

Interactions of GLIADEL Implant with other drugs or chemotherapy have not been formally evaluated.

Pregnancy and lactation

Pregnancy There are no studies of GLIADEL Implant in pregnant women and no studies assessing the reproductive toxicity of GLIADEL Implant. Carmustine, the active component of GLIADEL Implant, when administered ...

Effects on ability to drive and use machines

No effects on ability to drive and use machines have been observed. However, driving is not advisable following treatment.

Undesirable effects

The spectrum of undesirable effects observed in patients with newly-diagnosed high-grade malignant glioma and recurrent malignant gliomas was generally consistent with that encountered in patients undergoing ...

Overdose

Not applicable.

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents ATC Code: L01AD01 Preclinical data GLIADEL Implant delivers carmustine directly into the surgical cavity created after tumoural resection. On exposure to ...

Pharmacokinetic properties

The absorption, distribution, metabolism, and excretion of the copolymer in humans is unknown. Carmustine concentrations delivered by GLIADEL Implant in human brain tissue have not been determined. Plasma ...

Preclinical safety data

No carcinogenicity, mutagenicity, embryo-foetal toxicity, pre- and post-natal toxicity and impairment of fertility studies have been conducted with GLIADEL Implants. Carmustine, the active component of ...

List of excipients

Polifeprosan 20

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

Store in a freezer at or below -20°C. Unopened outer sachets may be kept at a temperature of not more than 22°C for a maximum of six hours. The product may be refrozen only once if the sachets have been ...

Nature and contents of container

GLIADEL Implant is available in a box containing eight implants. Each implant is individually packaged in two aluminium foil laminate sachets.

Special precautions for disposal and other handling

Implants should be handled by personnel wearing surgical gloves because exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use of double gloves is recommended and the outer ...

Marketing authorization holder

MGI PHARMA LIMITED, Holborn Gate, 1st Floor, 330 High Holborn, London,WC1V 7QT, United Kingdom

Marketing authorization number(s)

PL 18753/0001

Date of first authorization / renewal of the authorization

Date of first authorisation: 28/05/1999 Date of last renewal: 10/12/2008

Date of revision of the text

02 February 2015

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