Zlatal 20mg/0.8ml solution for injection pre-filled syringes

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Methotrexate sodium

Διαθέσιμο από:

Nordic Pharma Ltd

Φαρμακολογική κατηγορία (ATC):

L01BA01

INN (Διεθνής Όνομα):

Methotrexate sodium

Δοσολογία:

25mg/1ml

Φαρμακοτεχνική μορφή:

Solution for injection

Οδός χορήγησης:

Subcutaneous; Intramuscular

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 08010300; GTIN: 8718481141328

Αρχείο Π.Χ.Π.

OBJECT 1
ZLATAL 20MG SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
Summary of Product Characteristics Updated 30-Aug-2017 | Nordic Pharma
Limited
1. Name of the medicinal product
Zlatal 20 mg solution for injection in pre-filled syringe
2. Qualitative and quantitative composition
1 ml of solution contains 25 mg methotrexate (as methotrexate
disodium).
1 pre-filled syringe of 0.8 ml contains 20 mg methotrexate.
Contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially
'sodium-free'.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe.
Clear, yellow solution with a pH of 8.0 - 9.0 and an osmolality of
approximately 300 mOsm/kg
4. Clinical particulars
4.1 Therapeutic indications
Zlatal is indicated for the treatment of
-active rheumatoid arthritis in adult patients,
-polyarthritic forms of severe, active juvenile idiopathic arthritis,
when the response to nonsteroidal anti-
inflammatory drugs (NSAIDs) has been inadequate,
-severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy such
as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis
in adult patients.
- mild to moderate Crohn's disease either alone or in combination with
corticosteroids in adult patients
refractory or intolerant to thiopurines.
4.2 Posology and method of administration
Important warning with reference to the dosing of methotrexate:
Methotrexate for the therapy of rheumatic diseases or diseases of the
skin must only be used ONCE
WEEKLY.
Faulty dosing of methotrexate may lead to serious adverse effects
including fatal course. Please read this
paragraph of the SmPC very carefully.
Zlatal should only be prescribed by physicians with experience in the
various properties of the medicinal
product and its mode of action. Zlatal is injected once weekly.
It must be explicitly pointed out to the patient that Zlatal is
applied ONLY ONCE A WEEK.
It is recommended to specify a certain day of the week as “day for
injection”