Methotrexate (Hospira)

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Nopērc to tagad

Produkta apraksts Produkta apraksts (SPC)
01-10-2007

Aktīvā sastāvdaļa:

Methotrexate 10 mg/mL;  

Pieejams no:

Hospira NZ Ltd

SNN (starptautisko nepatentēto nosaukumu):

Methotrexate 10 mg/mL

Deva:

20 mg/2mL

Zāļu forma:

Solution for injection

Kompozīcija:

Active: Methotrexate 10 mg/mL   Excipient: Sodium chloride Sodium hydroxide Water for injection

Vienības iepakojumā:

Vial, glass, 5 x 2 mL, 10 mL

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Fermion Oy

Produktu pārskats:

Package - Contents - Shelf Life: Vial, glass, 2 mL - 5 dose units - 30 months from date of manufacture stored at or below 25°C protect from light

Autorizācija datums:

1982-07-29

Produkta apraksts

                                 
                      
             
Data Sheet – New Zealand 
 
Hosp 2.0 
                 1 
DBL
®
 METHOTREXATE INJECTION AND TABLETS 
 
NAME OF MEDICINE 
Methotrexate BP 
 
PRESENTATION 
DBL
®
 Methotrexate Injection is
a sterile solution of Methotrexate BP in Water for Injections
BP.  Sodium 
chloride is included for isotonicity except in the 1 g/10 mL
vial.  DBL
®
 Methotrexate Injection is preservative-
free.  DBL
®
 Methotrexate Injection has a pH of 7.5 to 9.0.  DBL
®
 Methotrexate Tablets contain 2.5 mg of 
Methotrexate BP. The 2.5 mg tablets are unscored. 
 
USES  
_ACTIONS _
Methotrexate is an antimetabolite and an analogue of folic acid. It
enters the cells via an active transport 
system for reduced folates and, due to a relatively
irreversible binding, exerts its cytotoxic effect by 
competitively inhibiting the enzyme dihydrofolate reductase which
catalyses the conversion of folic acid to 
tetrahydrofolate. This interferes with the synthesis of thymidylic
acid and purines which in turn inhibits 
DNA synthesis and cell reproduction and to a lesser extent protein
and RNA synthesis.  
 
The affinity of dihydrofolate reductase for methotrexate is far
greater than its affinity for folic or 
dihydrofolic acid and, therefore, even very large amounts of folic
acid given simultaneously will not 
reverse the effects of methotrexate. Methotrexate seems also to cause
an increase in intracellular 
deoxyadenosine triphosphate, which is thought to inhibit
ribonucleotide reduction and polynucleotide 
ligase, an enzyme concerned in DNA synthesis and repair. 
 
Methotrexate acts specifically on the S-phase of the cell cycle.
Tissues with a high cellular proliferation 
rate such as neoplastic tissue, bone marrow, epithelial cells or
foetal cells seem to be the most 
susceptible. Methotrexate is used for this reason in the
treatment of psoriasis, where the
                                
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