LUTRATE DEPOT Powder and solvent for prolonged-release suspension for injection Ref.[6974] Active ingredients: Leuprorelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Product name and form

Lutrate 1 month Depot 3.75 mg powder and solvent for prolonged-release suspension for injection.

Pharmaceutical Form

Powder and solvent for prolonged-release suspension for injection.

Powder: white to off-white powder.

Solvent: clear transparent solution (pH 5.0–7.0).

Qualitative and quantitative composition

Each vial contains 3.75 mg of leuprorelin acetate (equivalent to 3.57 mg leuprorelin free base).

1 ml of reconstituted suspension contains 1.875 mg of leuprorelin acetate.

Excipients with known effect: Each vial contains from 1.3 to 2.2 mg (<1 mmol) of sodium (as carmellose sodium).

For the full list of excipients, see section 6.1.

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 of the lyophilizate (vial):

Polysorbate 80
Mannitol (E421)
Carmellose sodium (E466)
Triethyl citrate
Poly(DL-lactide-co-glycolide) (PLGA)

Excipients of the solvent (prefilled syringe):

Mannitol (E421)
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injection

Pack sizes and marketing

The commercial kit includes:

  1. One (1) type I glass vial containing 3.75 mg of leuprorelin acetate as a freeze-dried powder, sealed with a bromobutyl stopper and an aluminium flip-off cap.
  2. One (1) type I glass prefilled syringe containing 2 ml of solvent sealed with an elastomer cap.
  3. One (1) polycarbonate / HDPE adaptor system including one (1) sterile 20 gauge needle.

Marketing authorization holder

Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 12762/0509

Date of first authorization: 16 June 2015

Drugs

Drug Countries
LUTRATE Austria, Estonia, Spain, Hong Kong, Croatia, Ireland, Lithuania, Malta, Poland, Romania
 
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