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SPC, UK: CYMEVENE Powder for concentrate for solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cymevene 500 mg powder for concentrate for solution for infusion.

Qualitative and quantitative composition

Each vial contains 500 mg of ganciclovir (as ganciclovir sodium). After reconstitution with 10 mL of water for injections, each mL provides 50 mg of ganciclovir. Excipient(s) with known effect: approximately ...

Pharmaceutical form

Powder for concentrate for solution for infusion (powder for concentrate). White to off-white solid cake.

Therapeutic indications

Cymevene is indicated in adults and adolescents ≥12 years of age for the: treatment of cytomegalovirus (CMV) disease in immunocompromised patients; prevention of CMV disease using pre-emptive therapy in ...

Posology and method of administration

Posology Treatment of CMV disease Adults and Paediatric Population ≥12 years of age with normal renal function Induction treatment: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours ...

Contraindications

Hypersensitivity to the active substance or valganciclovir or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).

Special warnings and precautions for use

Cross-hypersensitivity Due to the similarity of the chemical structure of ganciclovir and that of aciclovir and penciclovir, a cross-hypersensitivity reaction between these drugs is possible. Caution should ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetic interactions Probenecid Probenecid given with oral ganciclovir resulted in statistically decreased renal clearance of ganciclovir, and led to clinically significant increased exposure. ...

Fertility, pregnancy and lactation

Fertility A small clinical study with renal transplant patients receiving Valcyte for CMV prophylaxis for up to 200 days demonstrated an impact of valganciclovir/ganciclovir on spermatogenesis, with decreased ...

Effects on ability to drive and use machines

Ganciclovir may have a major influence on the ability to drive and use machines (see section 4.8).

Undesirable effects

Summary of the safety profile Valganciclovir is a pro-drug of ganciclovir, and adverse reactions associated with valganciclovir can be expected to occur with ganciclovir. Oral ganciclovir is no longer ...

Overdose

Symptoms Reports of overdoses with i.v. ganciclovir, some with fatal outcomes, have been received from clinical trials and during post-marketing experience. The majority of the reports were either not ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors ATC code: J05AB06 Mechanism of action Ganciclovir ...

Pharmacokinetic properties

The systemic exposure (AUC<sub>0-∞</sub>) reported following dosing with a single 1-hour IV infusion of 5mg/kg ganciclovir in adult liver transplant patients was on average 50.6 µg.h/mL (CV% 40). In this ...

Preclinical safety data

Ganciclovir was mutagenic in mouse lymphoma cells and clastogenic in mammalian cells. Such results are consistent with the positive mouse carcinogenicity study with ganciclovir. Ganciclovir is a potential ...

List of excipients

Sodium hydroxide (for pH-adjustment) Hydrochloric acid (for pH-adjustment)

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Do not use bacteriostatic water for injections containing ...

Shelf life

Shelf life: 3 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injections. Do ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions after reconstitution and after dilution of the medicinal product, see section 6.3.

Nature and contents of container

Single-dose glass vials of 10 mL with fluoro-resin laminated/siliconised rubber stopper and aluminum closure with flip-off cap. Available in packs of 1 vial or 5 vials. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

Caution should be exercised in the handling of Cymevene. Since Cymevene is considered a potential teratogen and carcinogen in humans, caution should be observed in its handling. Avoid inhalation or direct ...

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Marketing authorization number(s)

PL 27041/0013

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 June 1988 Date of latest renewal: 28 April 2016

Date of revision of the text

15/02/2019

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