Siklos 1000mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Hydroxycarbamide

可用日期:

Nordic Pharma Ltd

INN（国际名称）:

Hydroxycarbamide

剂量:

1gram

药物剂型:

Tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 09010300

产品特点

OBJECT 1
SIKLOS 1000MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-Jun-2018 | Nordic Pharma
Limited
1. Name of the medicinal product
Siklos 100 mg film-coated tablets.
Siklos 1000 mg film-coated tablets.
2. Qualitative and quantitative composition
Siklos 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of hydroxycarbamide.
Siklos 1000 mg film-coated tablets
Each film-coated tablet contains 1,000 mg of hydroxycarbamide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Siklos 100 mg film-coated tablets
Off-white oblong-shaped, film-coated tablet with half-scoring on both
sides.
The tablet can be divided into two equal parts. Each half of tablet is
embossed “H” on one side.
Siklos 1000 mg film-coated tablets
Off-white, capsule-shaped, film-coated tablet with triple scoring on
both sides.
The tablet can be divided into four equal parts. Each quarter of
tablet is embossed “T” on one side.
4. Clinical particulars
4.1 Therapeutic indications
Siklos is indicated for the prevention of recurrent painful
vaso-occlusive crises including acute chest
syndrome in adults, adolescents and children older than 2 years
suffering from symptomatic Sickle Cell
Syndrome (see section 5.1).
4.2 Posology and method of administration
Treatment with Siklos should be initiated by a physician experienced
in the management of Sickle Cell
Syndrome.
Posology
_In adults, adolescents and children older than 2 years _
The posology should be based on the patient's body weight (b.w.).
The starting dose of hydroxycarbamide is 15 mg/kg b.w. and the usual
dose is between 15 and 30 mg/kg
b.w./day.
As long as the patient responds to therapy either clinically or
haematologically (e.g. increase of
haemoglobin F (HbF), Mean Corpuscular Volume (MCV), neutrophil count)
the dose of Siklos should be
maintained.
In case of non-response (re-occurrence of crises or no decrease in
crisis rate) the daily dose may be
increased by steps of 2.5 to 5 mg/kg b.w./day using t