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SPC, UK: LUTRATE DEPOT Powder and solvent for prolonged-release suspension for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

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

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: ...

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).

Therapeutic indications

Metastatic prostate cancer. Locally advanced prostate cancer, as an alternative to surgical castration. As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced ...

Posology and method of administration

Posology The usual recommended dose of Lutrate 1 month Depot is 3.75 mg presented as a one month depot injection and administered as a single intramuscular injection every month. Lutrate 1 month Depot ...

Contraindications

Hypersensitivity to the active substance, luteinising hormone releasing hormone (LHRH) analogues or to any of the excipients listed in section 6.1. Reports of anaphylactic reactions to synthetic LHRH or ...

Special warnings and precautions for use

In the initial stages of Lutrate 1 month Depot treatment, as occurs during treatment with other LHRH agonists, a transient rise in levels of testosterone may occur. In some cases, this may be associated ...

Interaction with other medicinal products and other forms of interaction

No pharmacokinetic-based drug-drug interaction studies have been conducted with leuprorelin acetate. However, because leuprorelin acetate is a peptide that is primarily degraded by peptidase and not by ...

Fertility, pregnancy and lactation

Pregnancy Lutrate 1 month Depot is not indicated for use in pregnant women. Leuprorelin acetate injection may cause foetal harm when administered to a pregnant woman. Therefore, the possibility exists ...

Effects on ability to drive and use machines

No specific studies on the effects of Lutrate 1 month Depot on the ability to drive and use machines have been performed. However, the ability to drive and use machines may be impaired due to visual disturbances ...

Undesirable effects

Unless otherwise specified, the following safety profile of Lutrate 1 month Depot is based on the results of a phase III clinical trial in which prostate cancer patients were treated with six intramuscular ...

Overdose

There is no clinical experience with the effects of an acute overdose of Lutrate 1 month Depot or leuprorelin acetate. In clinical trials using daily subcutaneous leuprorelin acetate in patients with prostate ...

Pharmacodynamic properties

Pharmacotherapeutic group: Endocrine therapy. Hormones and related agents. Gonadotropin-releasing hormones analogues ATC code: L02AE02 Mechanism of action The chemical name of Leuprorelin acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L- ...

Pharmacokinetic properties

Absorption Following three once-monthly injections of Lutrate 1 month Depot in a sample of prostate cancer patients (N=12), maximal leuprorelin acetate plasma concentration was similar among the three ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity conducted with leuprorelin acetate. As expected from ...

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 ...

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. No other solvent other than the sterile solvent provided for Lutrate 1 month Depot can be ...

Shelf life

Shelf life: 3 years unopened. Once reconstituted with the solvent the suspension should be administered immediately.

Special precautions for storage

Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

The commercial kit includes: 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. One (1) type I ...

Special precautions for disposal and other handling

Method of administration The vial of Lutrate 1 month Depot microsphere powder should be reconstituted immediately prior to administration by intramuscular injection. Make sure an aseptic technique is followed. ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 12762/0509

Date of first authorization / renewal of the authorization

Date of first authorization: 16 June 2015

Date of revision of the text

04/07/2017

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