Urokinase 50,000unit powder for solution for injection vials

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Urokinase

Διαθέσιμο από:

medac UK

Φαρμακολογική κατηγορία (ATC):

B01AD04

INN (Διεθνής Όνομα):

Urokinase

Δοσολογία:

50000unit

Φαρμακοτεχνική μορφή:

Powder for solution for injection

Οδός χορήγησης:

Intravenous; Intraarterial

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: ; GTIN: 4037353123106

Αρχείο Π.Χ.Π.

OBJECT 1
UROKINASE 10,000 IU
Summary of Product Characteristics Updated 14-Mar-2018 | medac GmbH
1. Name of the medicinal product
Urokinase medac 10,000 I.U.
Urokinase medac 50,000 I.U.
Urokinase medac 100,000 I.U.
Urokinase medac 250,000 I.U.
Urokinase medac 500,000 I.U.
Powder for solution for injection or infusion
2. Qualitative and quantitative composition
Each vial contains 10,000, 50,000, 100,000, 250,000, or 500,000 I.U.
of human urokinase extracted from
human urine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion
4. Clinical particulars
4.1 Therapeutic indications
Lysis of blood clots in the following conditions:
• extensive acute proximal deep vein thrombosis
• acute massive pulmonary embolism
• acute occlusive peripheral arterial disease with limb threatening
ischaemia
• thrombosed arteriovenous haemodialysis shunts
• thrombosed intravascular catheters and cannulae
4.2 Posology and method of administration
Urokinase medac should only be used by physicians experienced in the
management of thrombotic
diseases in hospitals where adequate diagnostic and monitoring
techniques are available.
Depending on the indication, the route of administration of Urokinase
medac is by systemic intravenous
infusion, by local intra-arterial catheter-directed infusion during
arteriography, or by local instillation.
It must not be given by subcutaneous or intramuscular injection.
For instructions regarding reconstitution and further dilution of the
medicinal product before
administration, see section 6.6.
_ADULTS_
The dosage may be adjusted individually depending on the clinical
condition. The following dose
regimens should be used as a guideline.
Extensive acute proximal deep vein thrombosis
Urokinase medac should be administered by intravenous infusion into a
peripheral vein using an initial
dose of 4,400 I.U./kg bodyweight infused over 10 – 20 min, followed
by a maintenance dose of 100,000
I.U. per hour for 2 – 3 days.
Acute pulmonary embo