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XAGRID Capsule (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Xagrid 0.5 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride). Excipient(s) with known effect: Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous lactose (65.8 mg). For ...

Pharmaceutical form

Hard capsule. An opaque white hard capsule imprinted with S 063.

Therapeutic indications

Xagrid is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not ...

Posology and method of administration

Treatment with Xagrid should be initiated by a clinician with experience in the management of essential thrombocythaemia. Posology The recommended starting dose of anagrelide is 1 mg/day, which should ...

Contraindications

Hypersensitivity to anagrelide or to any of the excipients listed in section 6.1. Patients with moderate or severe hepatic impairment. Patients with moderate or severe renal impairment (creatinine clearance ...

Special warnings and precautions for use

Hepatic impairment The potential risks and benefits of anagrelide therapy in a patient with mild impairment of hepatic function should be assessed before treatment is commenced. It is not recommended in ...

Interaction with other medicinal products and other forms of interaction

Limited pharmacokinetic and/or pharmacodynamic studies investigating possible interactions between anagrelide and other medicinal products have been conducted. Effects of other active substances on anagrelide ...

Fertility, pregnancy and lactation

Women of child-bearing potential Women of child-bearing potential should use adequate birth-control measures during treatment with anagrelide. Pregnancy There are no adequate data from the use of anagrelide ...

Effects on ability to drive and use machines

In clinical development, dizziness was commonly reported. Patients are advised not to drive or operate machinery while taking anagrelide if dizziness is experienced.

Undesirable effects

Summary of the safety profile The safety of anagrelide has been examined in 4 open label clinical studies. In 3 of the studies 942 patients who received anagrelide at a mean dose of approximately 2 mg/day ...

Overdose

Post-marketing case reports of intentional overdose with anagrelide have been received. Reported symptoms include sinus tachycardia and vomiting. Symptoms resolved with conservative management. Anagrelide, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other antineoplastic agents ATC Code: L01XX35 Mechanism of action The precise mechanism by which anagrelide reduces blood platelet count is unknown. In cell culture studies, ...

Pharmacokinetic properties

Absorption Following oral administration of anagrelide in man, at least 70% is absorbed from the gastrointestinal tract. In fasted subjects, peak plasma levels occur about 1 hour after administration. ...

Preclinical safety data

Repeated dose toxicity Following repeated oral administration of anagrelide in dogs, subendocardial haemorrhage and focal myocardial necrosis was observed at 1mg/kg/day or higher in males and females with ...

List of excipients

<u>Capsule contents:</u> Povidone (E1201) Lactose, anhydrous Lactose monohydrate Cellulose, microcrystalline (E460) Crospovidone Magnesium stearate <u>Capsule shell:</u> Gelatin Titanium dioxide (E171) ...

Incompatibilities

Not applicable.

Shelf life

4 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

High-density polyethylene (HDPE) bottles with child-resistant closures and desiccant containing 100 capsules.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland

Marketing authorization number(s)

EU/1/04/295/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 16 November 2004 Date of latest renewal: 16 November 2014

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