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GANCICLOVIR sodium, eq. 500mg base, powder, vial

https://unicat.msf.org/cat/product/11687
STD DINJGANC5V-

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
6.4.3 - Other antivirals
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J05AB06
Anatomical Therapeutic Chemical Classification according to WHOCC
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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GANCICLOVIR

Therapeutic Action

Antiviral (nucleoside analogue)

Indications

Cytomegalovirus (CMV) infections

Instructions for use

Must be given as slow IV infusion.

  • Reconstitute the 500 mg powder vial with 10 ml of water for injection to obtain a reconstituted solution at 50 mg/ml ganciclovir.
  • Shake the vial for 60 seconds until complete dissolution of the contents, the reconstituted solution must be clear and free of visible particles.
  • Dilute the reconstituted solution at the required dose in 5% dextrose or 0.9% NaCl.

Monitor full blood count closely (severe deterioration may require correction and possibly treatment interruption).

Oral valganciclovir has an equivalent systemic effect for CMV and is the preferred treatment.

Precautions for Use

Warning! Haematologic toxicity, impairment of fertility, foetal toxicity, mutagenesis and carcinogenesis:

  • Haematologic toxicity: granulocytopenia, anaemia, thrombocytopenia, and pancytopenia.
  • Impairment of fertility: may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
  • Foetal toxicity: potential to cause birth defects
  • Mutagenesis and carcinogenesis: potential to cause cancers

Advise women of child bearing to use effective contraception during treatment and for at least 30 days after the last dose.

Not recommended during pregnancy or breast feeding, except in the absence of an alternative treatment.

To be used with caution in patients with impaired renal function. Monitor serum creatinine or creatinine clearance before and during treatment.

Do not administer by rapid or bolus IV injection (risk of increasing the
toxicity of ganciclovir.).

Do not administer by IM or SC injection (risk of severe tissue irritation).

Avoid inhalation of the powder or direct contact of the powder or reconstituted solution with the skin or mucous membranes; if contact occurs, wash thoroughly with soap and water; rinse eyes thoroughly with plain water.

Cytotoxic medicine!

  • Dangerous substance for the staff handling it.
  • Cytotoxic drugs should not be handled or administered by pregnant staff members.
  • It is mandatory to train the staff and wear gloves during preparation, dispensation, stock management and disposal.

(See introduction: Cytotoxic drugs in the MSF Supply Chain)

Storage

  • Below 25ºC
  • Do not refrigerate or freeze.
  • After reconstitution, use the solution immediately; discard any unused open vial.