ZOLADEX Implant, in pre-filled syringe (2017)
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Περιεχόμενα
Name of the medicinal product
Zoladex 3.6 mg Implant.
Qualitative and quantitative composition
Goserelin acetate (equivalent to 3.6 mg goserelin). For the full list of excipients, see section 6.1.
Pharmaceutical form
Implant, in pre-filled syringe.
Therapeutic indications
Treatment of prostate cancer in the following settings (see also section 5.1):In the treatment of metastatic prostate cancer where Zoladex has demonstrated comparable survival benefits to surgical castrations ...
Posology and method of administration
Posology Adults One 3.6 mg depot of Zoladex injected subcutaneously into the anterior abdominal wall, every 28 days. No dosage adjustment is necessary for patients with renal or hepatic impairment, or ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pregnancy and lactation (see section 4.6).
Special warnings and precautions for use
There is an increased risk of incident depression (which may be severe) in patients undergoing treatment with GnRH agonists, such as Goserelin. Patients should be informed accordingly and treated as appropriate ...
Interaction with other medicinal products and other forms of interaction
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of Zoladex with medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de ...
Pregnancy and lactation
Pregnancy Zoladex should not be used during pregnancy since concurrent use of LHRH agonists is associated with a theoretical risk of abortion or foetal abnormality. Prior to treatment, potentially fertile ...
Effects on ability to drive and use machines
Zoladex has no or negligible influence on the ability to drive and use machines.
Undesirable effects
The following frequency categories for adverse drug reactions (ADRs) were calculated based on reports from Zoladex clinical trials and post-marketing sources. The most commonly observed adverse reactions ...
Overdose
There is not much experience of overdose in humans. In cases where Zoladex has been given before the planned time of administration, or when a bigger dose of Zoladex than originally planned has been given, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Gonadotropin releasing hormone analogues ATC code: L02AE03 Zoladex (D-Ser(But)<sup>6</sup> Azgly<sup>10</sup> LHRH) is a synthetic analogue of naturally occurring LHRH. On chronic ...
Pharmacokinetic properties
The bioavailability of Zoladex is almost complete. Administration of a depot every four weeks ensures that effective concentrations are maintained with no tissue accumulations. Zoladex is poorly protein ...
Preclinical safety data
Following long-term repeated dosing with Zoladex, an increased incidence of benign pituitary tumours has been observed in male rats. Whilst this finding is similar to that previously noted in this species ...
List of excipients
Lactide/glycolide copolymer
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Single dose Safe System syringe applicator with a protective sleeve.
Special precautions for disposal and other handling
Use as directed by the prescriber. Use only if pouch is undamaged. Use immediately after opening pouch. Dispose of the syringe in an approved sharps collector.
Marketing authorization holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK
Marketing authorization number(s)
PL 17901/0064
Date of first authorization / renewal of the authorization
Date of first authorisation: 1<sup>st</sup> May 2001 (formerly 13.05.1993) Date of latest renewal: 24<sup>th</sup> November 2005
Date of revision of the text
24<sup>th</sup> January 2017
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