Spectrila 10,000unit powder for concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Asparaginase

Available from:

medac UK

ATC code:

L01XX02

INN (International Name):

Asparaginase

Dosage:

10000unit

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 4037353016651

Summary of Product characteristics

OBJECT 1
SPECTRILA 10,000 U POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 18-Aug-2017 | medac GmbH
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Spectrila 10,000 U powder for concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 10,000 units of asparaginase*.
One unit (U) is defined as the quantity of enzyme required to liberate
one µmol ammonia per minute at
pH 7.3 and 37°C.
After reconstitution each ml contains 2,500 units of asparaginase.
*Produced in _Escherichia coli _cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
White powder.
4. Clinical particulars
4.1 Therapeutic indications
Spectrila is indicated as a component of antineoplastic combination
therapy for the treatment of acute
lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18
years and adults.
4.2 Posology and method of administration
Spectrila should be prescribed and administered by physicians and
health care personnel experienced in
the use of antineoplastic products. It should only be given in a
hospital setting where appropriate
resuscitation equipment is available.
Posology
Spectrila is usually employed as part of combination chemotherapy
protocols with other antineoplastic
agents (see also section 4.5).
_Adults and children older than 1 year _
The recommended intravenous dose of asparaginase is 5,000 units per
square metre (U/m²) body surface
area (BSA) given every third day.
Treatment may be monitored based on the trough serum asparaginase
activity measured three days after
administration of Spectrila. If asparaginase activity values fail to
reach target levels, a switch to a
different