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SPC, UK: COSMEGEN Lyophilised powder for solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

COSMEGEN LYOVAC 500 micrograms powder for solution for injection.

Qualitative and quantitative composition

Cosmegen Lyovac is supplied as a yellow-orange, lyophilised powder, in a vial containing 500 micrograms dactinomycin with 20 mg mannitol E421.

Pharmaceutical form

Lyophilised powder for solution for injection.

Therapeutic indications

Cosmegen is a cytotoxic, antineoplastic antibiotic with immunosuppressant properties. Cosmegen, as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment ...

Posology and method of administration

Toxic reactions due to Cosmegen are frequent and may be severe (see 4.8 Undesirable effects), thus limiting the amount that may be administered in many cases. However, the severity of toxicity varies markedly ...

Contraindications

Hypersensitivity to any component of this product. Use in patients with varicella or herpes zoster. If Cosmegen is given at or about the time of infection with chickenpox or herpes zoster, a severe generalised ...

Special warnings and precautions for use

Cosmegen should be administered only under the supervision of a physician who is experienced in the use of a cancer chemotherapeutic agent. Due to the toxic properties of dactinomycin (e.g. corrosivity, ...

Interaction with other medicinal products and other forms of interaction

Much evidence suggests that Cosmegen potentiates the effects of X-ray therapy. The converse also appears likely: that Cosmegen may be more effective when radiation therapy is given concurrently. See 4.4 ...

Pregnancy and lactation

Dactinomycin has been shown to be teratogenic in animals and should not normally be given to pregnant women. Cosmegen, dactinomycin should not be administered to mothers who are breast-feeding.

Effects on ability to drive and use machines

There are no data available. The potential side effects, fatigue and lethargy, should be taken into account (see 4.8 Undesirable effects).

Undesirable effects

Toxic effects (except nausea and vomiting) do not usually become apparent until two to four days after a course of therapy is stopped, and may not peak until one to two weeks have elapsed. Deaths have ...

Overdose

In the event of overdosage, dactinomycin therapy should be withdrawn immediately. Limited information is available on overdosage in humans. Manifestations of overdose have included nausea, vomiting, diarrhoea, ...

Pharmacodynamic properties

Mode of action: Cosmegen inhibits the proliferation of cells by forming a stable complex with DNA and interfering with DNA-dependent RNA synthesis. Generally, the actinomycins exert an inhibitory effect ...

Pharmacokinetic properties

Results of a study in patients with malignant melanoma indicate that dactinomycin (<sup>3</sup>H actinomycin D) is minimally metabolised, is concentrated in nucleated cells and does not penetrate the blood ...

Preclinical safety data

The international Agency on Research on Cancer has judged that dactinomycin is a positive carcinogen in animals. Local sarcomas were produced in mice and rats after repeated subcutaneous or intraperitoneal ...

List of excipients

Mannitol E421

Incompatibilities

Use of water containing preservatives (benzyl alcohol or parabens) to reconstitute Cosmegen for injection results in the formation of a precipitate.

Shelf life

The shelf-life is 36 months.

Special precautions for storage

Store below 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.

Nature and contents of container

Glass vials containing 500 micrograms dactinomycin with 20 mg mannitol.

Special precautions for disposal and other handling

Reconstitution and administration Cosmegen is reconstituted by adding 1.1 ml of water for Injections Ph Eur without preservative to the vial. For injection, 1.0 ml of the reconstituted solution, which ...

Marketing authorization holder

Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France

Marketing authorization number(s)

PL 15266/0018

Date of first authorization / renewal of the authorization

Date of grant at last renewal: 12 July 2006

Date of revision of the text

30 September 2019

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