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SPC: TEMODAL Capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Temodal 5 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 5 mg temozolomide. Excipient with known effect: Each hard capsule contains 132.8 mg of anhydrous lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Hard capsule (capsule). The hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink. The cap is imprinted with Temodal. The body is imprinted with 5 mg, the Schering-Plough ...

Therapeutic indications

Temodal is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. children from the ...

Posology and method of administration

Temodal should only be prescribed by physicians experienced in the oncological treatment of brain tumours. Anti-emetic therapy may be administered (see section 4.4). Posology Adult patients with newly-diagnosed ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to dacarbazine (DTIC). Severe myelosuppression (see section 4.4).

Special warnings and precautions for use

Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the ...

Interaction with other medicinal products and other forms of interaction

In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole ...

Fertility, pregnancy and lactation

Pregnancy There are no data in pregnant women. In preclinical studies in rats and rabbits receiving 150 mg/m² TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3). Temodal should ...

Effects on ability to drive and use machines

TMZ has minor influence on the ability to drive and use machines due to fatigue and somnolence (see section 4.8).

Undesirable effects

Summary of the safety profile Clinical trial experience In patients treated with TMZ in clinical trials, the most common adverse reactions were nausea, vomiting, constipation, anorexia, headache, fatigue, ...

Overdose

Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was haematological and was reported with any dose but is ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents Other alkylating agents ATC code: L01AX03 Mechanism of action Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to ...

Pharmacokinetic properties

TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC). MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide ...

Preclinical safety data

Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs. The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, ...

List of excipients

Capsule content: Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid Stearic acid *Capsule shell: Gelatin, Titanium dioxide (E 171) Sodium laurilsulfate Yellow iron ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Bottle presentation: Do not store above 30°C. Store in the original bottle in order to protect from moisture. Keep the bottle tightly closed. Sachet presentation: Do not store above 30°C.

Nature and contents of container

Bottle presentation: Type I amber glass bottles with polypropylene child-resistant closures containing 5 or 20 hard capsules. The carton contains one bottle. Sachet presentation: Sachets are composed of ...

Special precautions for disposal and other handling

Capsules should not be opened. If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided. If Temodal comes into contact with skin or mucosa, it should be ...

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/98/096/001 EU/1/98/096/002 EU/1/98/096/024 EU/1/98/096/025

Date of first authorization / renewal of the authorization

Date of first authorisation: 26 January 1999 Date of latest renewal: 26 January 2009

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