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SPC: TEMODAL Powder for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Temodal 2.5 mg/ml powder for solution for infusion.

Qualitative and quantitative composition

Each vial contains 100 mg of temozolomide. After reconstitution, 1 ml solution for infusion contains 2.5 mg temozolomide. Excipient with known effect: Each vial contains 2.4 mmol sodium. For the full list ...

Pharmaceutical form

Powder for solution for infusion. White powder.

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 with hard capsules In patients treated with TMZ in clinical trials, the most common adverse reactions were nausea, vomiting, constipation, anorexia, ...

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 5amino-imidazole4carboxamide ...

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

Mannitol (E421) Threonine Polysorbate 80 Sodium citrate (for pH adjustment) Hydrochloric acid concentrated (for pH adjustment)

Incompatibilities

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

Shelf life

Shelf life Unopened vial: 4 years. Reconstituted solution: after reconstitution the chemical and physical in-use stability has been demonstrated for 14 hours at 25°C, including infusion time. From a microbiological ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet. Each vial contains 100 mg TMZ. Temodal 2.5 mg/ml is supplied as a pack of 1 vial. ...

Special precautions for disposal and other handling

Caution must be exercised in handling Temodal 2.5 mg/ml powder for solution for infusion. The use of gloves and aseptic technique is required. If Temodal 2.5 mg/ml comes into contact with skin or mucosa, ...

Marketing authorization holder

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

Marketing authorization number(s)

EU/1/98/096/023

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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