CYMEVENE 500 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

GANCICLOVIR SODIUM

Tilgængelig fra:

TZAMAL BIO-PHARMA LTD

ATC-kode:

J05AB06

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

GANCICLOVIR SODIUM 500 MG

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Terapeutisk gruppe:

GANCICLOVIR

Terapeutisk område:

GANCICLOVIR

Terapeutiske indikationer:

Cymevene IV is indicated for the treatment of CMV retinitis in immunocompromised patiens, including patients with acquired immunodeficiency syndrome (AIDS). Cymevene IV is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease.

Autorisation dato:

2013-05-31

Produktets egenskaber

Page 1 of 20
CYMEVENE
® 500 MG
FULL PRESCRIBING INFORMATION
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL
TOXICITY,
MUTAGENESIS AND CARCINOGENESIS
•
HEMATOLOGIC TOXICITY: GRANULOCYTOPENIA, ANEMIA, THROMBOCYTOPENIA, AND
PANCYTOPENIA HAVE BEEN REPORTED IN
PATIENTS TREATED WITH CYMEVENE 500 MG _[SEE WARNINGS AND PRECAUTIONS
(5.1)]. _
•
IMPAIRMENT OF FERTILITY: BASED ON ANIMAL DATA AND LIMITED HUMAN DATA,
CYMEVENE 500 MG MAY CAUSE
TEMPORARY OR PERMANENT INHIBITION OF SPERMATOGENESIS IN MALES AND
SUPPRESSION OF FERTILITY IN FEMALES _[SEE _
_WARNINGS AND PRECAUTIONS (5.3)]._
•
FETAL TOXICITY: BASED ON ANIMAL DATA, CYMEVENE 500 MG HAS THE
POTENTIAL TO CAUSE BIRTH DEFECTS IN HUMANS
_[SEE WARNINGS AND PRECAUTIONS (5.4)]. _
•
MUTAGENESIS AND CARCINOGENESIS: BASED ON ANIMAL DATA, CYMEVENE 500 MG
HAS THE POTENTIAL TO CAUSE
CANCERS IN HUMANS _[SEE WARNINGS AND PRECAUTIONS (5.5)]._
NAME OF THE MEDICINAL PRODUCT
CYMEVENE
®
500 MG
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 543 mg ganciclovir sodium equivalent to 500 mg
ganciclovir
For a full list of excipients, see section 11.
PHARMACEUTICAL FORM
Powder for solution for infusion
white to off-white powder.
CLINICAL PARTICULARS
1 INDICATIONS AND USAGE
CYMEVENE 500 MG is indicated for the treatment of CMV retinitis in
immunocompromised patients, including patients
with acquired immunodeficiency syndrome (AIDS). CYMEVENE 500 MG is
also indicated for the prevention of CMV
disease in transplant recipients at risk for CMV disease (see
_Clinical Studies 14.1, 14.2_
).
SAFETY AND EFFICACY OF
CYMEVENE 500 MG
HAVE NOT BEEN ESTABLISHED FOR CONGENITAL OR
NEONATAL CMV DISEASE; NOR FOR THE TREATMENT OF ESTABLISHED CMV DISEASE
OTHER THAN
RETINITIS; NOR FOR USE IN NON-IMMUNOCOMPROMISED INDIVIDUALS.
Page 2 of 20
2
DOSAGE AND ADMINISTRATION
CAUTION - DO NOT ADMINISTER CYMEVENE 500 MG SOLUTION BY RAPID OR BOLUS
INTRAVENOUS
INJECTION. THE TOXICITY OF CYMEVENE 500 MG MAY BE INCREASED AS A
RESULT OF EXCESSIVE
PLASMA LEVELS.
CAUTION - INTRAMUSCULAR OR SUBCUTAN