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ZYTIGA Tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

ZYTIGA 250 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains 250 mg of abiraterone acetate. <u>Excipients with known effect:</u> Each tablet contains 189 mg of lactose and 6.8 mg of sodium. For the full list of excipients, see section 6.1. ...

3. Pharmaceutical form

Tablet. White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side.

4.1. 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 ...

4.2. Posology and method of administration

This medicinal product should be prescribed by an appropriate healthcare professional. Posology The recommended dose is 1,000 mg (four 250 mg tablets) as a single daily dose that must not be taken with ...

4.3. 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 ...

4.4. 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 ...

4.5. 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 ...

4.6. 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 ...

4.7. Effects on ability to drive and use machines

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

4.8. 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, ...

4.9. 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 ...

5.1. Pharmacodynamic properties

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

5.2. 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 ...

5.3. 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 ...

6.1. List of excipients

Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Povidone (K29/K32) Colloidal anhydrous silica Sodium laurilsulfate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

This medicinal product does not require special storage conditions.

6.5. Nature and contents of container

Round white HDPE bottles fitted with a polypropylene child-resistant closure containing 120 tablets. Each pack contains one bottle.

6.6. Special precautions for disposal and other handling

Based on its mechanism of action, this medicinal product may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle it without protection, e.g., gloves. Any unused ...

7. Marketing authorization holder

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

8. Marketing authorization number(s)

EU/1/11/714/001

9. Date of first authorization / renewal of the authorization

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

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