GANCICLOVIR MEDI-MARKET 500 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GANCICLOVIR AS SODIUM

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

J05AB06

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GANCICLOVIR AS SODIUM 500 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

HAINAN POLY PHARM CO., LTD., , PEOPLE’S REPUBLIC OF CHINA

Therapeutic area:

GANCICLOVIR

Therapeutic indications:

Ganciclovir Medi-Market 500 mg is indicated for the treatment of CMV retinitis in immunocompromised patiens, including patients with acquired immunodeficiency syndrome (AIDS). Ganciclovir Medi-Market 500 mg is also indicated for the prevention of CMV disease in transplant recipients at risk for CMV disease.

Authorization date:

2023-07-05

Summary of Product characteristics

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GANCICLOVIR MEDI-MARKET
500
MG
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
GANCICLOVIR MEDI-MARKET 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 concentrate for solution for infusion
white lyophilized powder for concentrate for solution for infusion.
CLINICAL PARTICULARS
1
INDICATIONS AND USAGE
GANCICLOVIR MEDI-MARKET 500 MG is indicated for the treatment of CMV
retinitis in immunocompromised patients,
including patients with acquired immunodeficiency syndrome (AIDS).
GANCICLOVIR MEDI-MARKET 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
GANCICLOVIR MEDI-MARKET 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.
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 intravenous GANCICLOVIR 500 MG _[see Warnings
and Precautions (5.1)]._
•
Impairment of Fertility: Based on animal data and limited human data,
GANCICLOVIR MEDI-MARKET 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, GANCICLOVIR MEDI-MARKET 500 MG
has the potential to cause birth
defects in humans_ [see Warnings and Precautions (5.4)]. _
•
Mutagenesis and Carcinogenesis: Based on animal data, GANCICLOVIR
MEDI-MARKET 500 MG has the
potential to cause cancers in humans _[see Warnings and Precautions
(5.5)]._
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DOSAGE AND ADMINISTRATION
CAUTION - DO NOT ADMINISTER GANCI