LECTRUM Powder for suspension for injection Ref.[50746] Active ingredients: Leuprorelin

Source: Marketing Authorisation Holder  Revision Year: 2019 

Product name and form

Lectrum 3.75mg.

Lectrum 7.50mg.

Lectrum 11.25mg.

Chemical name: 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-Larginyl-N-ethyl-L-prolinamide

Molecular formula: C59H84N16O12

CAS: 53714-56-0

Pharmaceutical Form

Powder for suspension for injection.

Qualitative and quantitative composition

Each vial with powder for suspension for injection contains 3.75mg; 7.5mg or 11.25mg of leuprolide acetate.

Active Ingredient Description
Leuprorelin

Leuprorelin is inactive when given orally due to poor membrane permeability and an almost complete inactivation by intestinal proteolytic enzymes. Leuprorelin has potent LHRH agonist properties when given during short-term and intermittent therapy, however, when administered in a continuous, nonpulsatile manner, LHRH analogs induce inhibition of gonadotropin secretion and suppression of testicular steroidogenesis.

List of Excipients

Excipients Lectrum 3.75 mg and Lectrum 7.5 mg

Gelatine
PLGA (copoly (DL-lactic acid/glycolic acid (75:25 mol %))
Mannitol

Each vial of diluent contains:

Sodium carboxymethylcellulose
Mannitol
Polysorbate 80
Water for injections

Excipients Lectrum 11.25 mg

Gelatine
PLA: polylactic acid
Mannitol

Each vial of diluent contains:

Sodium carboxymethylcellulose
Mannitol
Polysorbate 80
Water for injections

Pack sizes and marketing

Drugs

Drug Countries
LECTRUM Brazil, Ecuador

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