DIPHERELINE Powder and solvent for suspension for injection (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Triptorelin embonate.

2. Qualitative and quantitative composition

Diphereline 3.75mg 1 month formulation: Each vial contains a triptorelin content which allows the administration of an effective dose of 3.75 mg triptorelin. After reconstitution in 2 mL of solvent, ...

3. Pharmaceutical form

Powder and solvent for suspension for injection, prolonged release granules. White to off-white powder.

4.1. Therapeutic indications

Diphereline is indicated for the treatment of hormone-dependent locally advanced or metastatic prostate cancer. Diphereline 22.5mg 6 month formulation only: Diphereline 22.5 mg is indicated for ...

4.2. Posology and method of administration

Diphereline 3.75mg 1month formulation: The recommended dose of Diphereline is 3.75 mg triptorelin (1 vial) administered once a month as a single intramuscular injection. Diphereline 11.25mg ...

4.3. Contraindications

Diphereline is contraindicated in patients with known hypersensitivity to the active substance triptorelin, GnRH, other GnRH agonist analogues or to any of the excipients (see Section 6.1 LIST OF EXCIPIENTS). ...

4.4. Special warnings and precautions for use

Prostate Cancer Initially triptorelin causes a transient increase in serum testosterone levels. As a consequence, isolated cases of transient worsening of signs and symptoms of prostate cancer may occasionally ...

4.5. Interaction with other medicinal products and other forms of interaction

Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Diphereline with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade ...

4.6. Fertility, pregnancy and lactation

Effects on fertility In chronic toxicity studies at clinically relevant doses, triptorelin induced changes in the reproductive organs of male rats, dogs and monkeys. These were considered to reflect the ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However the ability to drive and use machines may be impaired should the patient experience dizziness, somnolence, ...

4.8. Undesirable effects

Reporting suspected adverse effects Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal ...

4.9. Overdose

The pharmaceutical properties of Diphereline and its route of administration make accidental or intentional overdose unlikely. There is no experience of overdose from clinical trials. Animal tests suggest ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Hormones and related agents, gonadotropin releasing hormone analogues ATC code: L02AE04 Mechanism of action Triptorelin, a gonadotrophin releasing hormone (GnRH) ...

5.2. Pharmacokinetic properties

Absorption In a sub-study of the pivotal efficacy trial DEB-96-TRI-01 of the 1- and 3-month doses in patients with prostate cancer, triptorelin exposure based on plasma AUC was comparable after intramuscular ...

5.3. Preclinical safety data

Genotoxicity In vitro genotoxicity tests for gene mutations and chromosomal damage, and a mouse micronucleus test have provided no evidence for genotoxic effects. Carcinogenicity Carcinogenicity ...

6.1. List of excipients

Composition of the Powder: Polyglactin Mannitol Carmellose sodium Polysorbate 80 Composition of the Solvent: Water for Injections

6.2. Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging. After opening: ...

6.4. Special precautions for storage

Store below 25°C. For storage conditions after first opening of the medicinal product, see Section 6.3 SHELF LIFE.

6.5. Nature and contents of container

Diphereline 3.75 mg 1 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and purple aluminium flip-off capsule. Diphereline 11.25 mg 3 month formulation: 6 ...

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

7. Marketing authorization holder

Ipsen Pty Ltd, Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley Victoria 3150 Telephone: 1800 317 033

9. Date of first authorization / renewal of the authorization

Date of first approval: 28 August 2006

10. Date of revision of the text

15 December 2022

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