Soliris 300mg

$4,000.00

Category: HUMAN-GROWTH-HORMONE

Description
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Buy Soliris 300mg

SYNTHESIS

VIDAL pharmacotherapeutic classification

Buy Hemostasis – Hematopoiesis – Hemoglobinopathies > Hemoglobinopathy > Monoclonal antibodies ( Eculizumab )

Immunology – Transplantation > Selective immunosuppressants > Antilymphocyte antibodies > Monoclonal antibodies ( Eculizumab )

Neurology > Antimyasthenic > Monoclonal antibodies ( Eculizumab )

ATC classification

ANTINEOPLASTICS AND IMMUNOMODULATORS > IMMUNOSUPPRESSANTS > IMMUNOSUPPRESSANTS > COMPLEMENT INHIBITORS ( ECULIZUMAB )

Substanceeculizumab

Excipients

monosodium phosphate , disodium phosphate , sodium chloride , polysorbate 80 , water for injection

Excipients with known effect:

EEN with threshold dose: sodium

Presentation

SOLIRIS 300 mg S dilute perf Fl/ 30ml

Cip: 3400957113841

Storage conditions: Before opening: 2° < t < 8° for 30 months (Keep away from light, Keep in its packaging, Keep in the refrigerator, Do not freeze)

Marketed

PRESCRIPTION/DISPENSING/COVERAGE

List I
Medicine reserved for hospital use.
Prescription reserved for specialists in hematology, internal medicine, nephrology, pediatrics, or neurology.
Medicine requiring special monitoring during treatment.

AMM

EU/1/07/393/001; CIP 3400957113841 (Fl/30ml).

Approved for communities and included on the list of specialties supported in addition to T2A for:

treatment of pediatric and adult patients with atypical HUS.
treatment of adult patients with PNH with a history of transfusion.
the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who have anti-aquaporin 4 (AQP4) antibodies, who have the relapsing form of the disease (2 attacks in the last year or 3 attacks in the last two years including one in the previous year), and who have failed background immunosuppressive treatments (rituximab, azathioprine, mycophenolate mofetil). Management must be provided in a multiple sclerosis resource and skills center or in a center of the MIRCEM network (rare inflammatory diseases of the brain and spinal cord), with a prescription restricted to neurologists within the framework of a multidisciplinary RCP, justified in view of the risk of using SOLIRIS beyond the reimbursement scope defined by the Commission on the basis of the available data on efficacy and tolerance, in particular first-line use or in patients without anti-AQP4 antibodies (off-label).

Not approved for use in communities for the treatment of generalized acquired myasthenia gravis (GAg).

Price and liability rate (excluding VAT) per UCD: UCD 3400892992075 (30 ml bottle): 1895.339 euros.

Source: RCP of 07/24/2023

FORMS and PRESENTATIONS

Solution for dilution for infusion, clear, colourless, pH 7.0.
30 mL of solution for dilution in a vial (type I glass) with a stopper (butyl siliconised) and a cap (aluminium) with a flip-off cap (polypropylene). Box of one vial.

COMPOSITION

Eculizumab is a humanized monoclonal antibody (IgG _2/4 κ ) produced in an NSO cell line by recombinant DNA technology.

One 30 mL vial contains 300 mg eculizumab (10 mg/mL).

After dilution, the final concentration of the solution to be infused is 5 mg/mL.

Excipient(s) with known effect: sodium (5 mmol per vial).

Excipients:

Monosodium phosphate, disodium phosphate, sodium chloride, polysorbate 80, water for injections.

INDICATIONS

Soliris is indicated in adults and children for the treatment of:

Paroxysmal nocturnal haemoglobinuria (PNH).
Evidence of clinical benefit has been demonstrated in patients who present with haemolysis and clinical symptom(s) indicating high disease activity, regardless of transfusion history (see section Pharmacodynamics ).
Atypical hemolytic uremic syndrome (aHUS) (see Pharmacodynamics section ).
Refractory generalized acquired myasthenia gravis (GAM) in patients aged 6 years and older with anti-acetylcholine receptor (aRach) antibodies (see section Pharmacodynamics ).

Soliris is indicated in adults for the treatment of:

Neuromyelitis optica spectrum disorder (NMOSD) in patients with antiaquaporin 4 (AQP4) antibodies with relapsing disease (see section Pharmacodynamics ).