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ZYTIGA Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ZYTIGA 500 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 500 mg of abiraterone acetate. Excipients with known effect: Each film-coated tablet contains 253.2 mg of lactose and 13.5 mg of sodium. For the full list of excipients, ...

Pharmaceutical form

Film-coated tablet. Purple, oval-shaped, film-coated tablets (20 mm long by 10 mm wide), debossed with AA on one side and 500 on the other side.

Therapeutic indications

ZYTIGA is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation ...

Posology and method of administration

This medicinal product should be prescribed by an appropriate healthcare professional. Posology The recommended dose is 1,000 mg (two 500 mg tablets) as a single daily dose that must not be taken with ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Women who are or may potentially be pregnant (see section 4.6). Severe hepatic impairment [Child-Pugh Class C ...

Special warnings and precautions for use

Hypertension, hypokalaemia, fluid retention and cardiac failure due to mineralocorticoid excess ZYTIGA may cause hypertension, hypokalaemia and fluid retention (see section 4.8) as a consequence of increased ...

Interaction with other medicinal products and other forms of interaction

Effect of food on abiraterone acetate Administration with food significantly increases the absorption of abiraterone acetate. The efficacy and safety when given with food have not been established therefore ...

Fertility, pregnancy and lactation

Women of childbearing potential There are no human data on the use of ZYTIGA in pregnancy and this medicinal product is not for use in women of childbearing potential. Contraception in males and females ...

Effects on ability to drive and use machines

ZYTIGA has no or negligible influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile In an analysis of adverse reactions of composite Phase 3 studies with ZYTIGA, adverse reactions that were observed in ≥10% of patients were peripheral oedema, hypokalaemia, ...

Overdose

Human experience of overdose with ZYTIGA is limited. There is no specific antidote. In the event of an overdose, administration should be withheld and general supportive measures undertaken, including ...

Pharmacodynamic properties

Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents ATC code: L02BX03 Mechanism of action Abiraterone acetate (ZYTIGA) is converted in vivo to abiraterone, an androgen ...

Pharmacokinetic properties

Following administration of abiraterone acetate, the pharmacokinetics of abiraterone and abiraterone acetate have been studied in healthy subjects, patients with metastatic advanced prostate cancer and ...

Preclinical safety data

In all animal toxicity studies, circulating testosterone levels were significantly reduced. As a result, reduction in organ weights and morphological and/or histopathological changes in the reproductive ...

List of excipients

<u>Tablet core:</u> Microcrystalline cellulose (silicified) Croscarmellose sodium Hypromellose 2910 (15 mPa.S) Lactose monohydrate Magnesium stearate Colloidal anhydrous silica Sodium laurilsulfate <u> ...

Incompatibilities

Not applicable.

Shelf life

2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVdC/PE/PVC/aluminum blister of 14 film-coated tablets in a cardboard wallet. Each carton contains (56 film-coated tablets) 4 wallets. PVdC/PE/PVC/aluminum blister of 12 film-coated tablets in a cardboard ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. This medicinal product may pose a risk to the aquatic environment (see section 5.3).

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Marketing authorization number(s)

EU/1/11/714/002 56 film-coated tablets (4 wallet packs of 14) EU/1/11/714/003 60 film-coated tablets (5 wallet packs of 12)

Date of first authorization / renewal of the authorization

Date of first authorisation: 05 September 2011 Date of latest renewal: 26 May 2016

Date of revision of the text

26 February 2019

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