उत्पाद विवरण
1. Technical Specifications
| Attribute |
Details |
| Brand Name |
Gavir Injection |
| Generic Name |
Ganciclovir |
| Strength |
500 mg per vial |
| Dosage Form |
Lyophilized powder for injection (to be reconstituted) |
| Route of Administration |
Intravenous (IV) infusion |
| Packaging Type |
Single-use vial |
| Medicine Type |
Antiviral (Synthetic nucleoside analog) |
| Manufacturer |
United Biotech Pvt. Ltd. / Other licensed manufacturers |
| Distributed By |
Authorized distributors |
2. Product Description
Gavir 500 mg Injection contains Ganciclovir, an antiviral drug that inhibits viral DNA synthesis.
It is primarily used in immunocompromised patients such as those with HIV/AIDS, cancer chemotherapy, or organ transplantation to treat and prevent cytomegalovirus (CMV) infections.
The drug is administered by intravenous infusion after reconstitution with sterile water and dilution in compatible IV fluids.
3. Product Highlights
| Attribute |
Details |
| Therapeutic Category |
Antiviral (Nucleoside analog) |
| Application Area |
Treatment & prophylaxis of CMV infections in immunocompromised patients |
| Mechanism of Action |
Phosphorylated to active triphosphate inhibits viral DNA polymerase blocks viral DNA replication |
| Administration |
Intravenous infusion (not to be given as IV bolus or IM) |
| Storage Conditions |
Store vials below 25 C; reconstituted solution stable for limited time under refrigeration |
4. Therapeutic Uses
-
Treatment of CMV retinitis in patients with AIDS
-
Prevention of CMV disease in solid organ or bone marrow transplant recipients
-
May also be used in other severe CMV infections (as per physicians discretion)
5. Side Effects
Common:
-
Fever, rash, sweating
-
Nausea, vomiting, diarrhea
-
Anemia, neutropenia, thrombocytopenia (low blood counts)
-
Headache, insomnia
Serious / Severe:
-
Bone marrow suppression (risk of infection, bleeding)
-
Kidney dysfunction (increased serum creatinine)
-
Liver toxicity (elevated liver enzymes)
-
Seizures, confusion, hallucinations (rare but possible)
6. Precautions
-
Bone Marrow Function: Monitor complete blood counts (CBC) frequently; discontinue if severe cytopenia develops.
-
Kidney Function: Dose adjustment required in renal impairment; hydration is important to reduce nephrotoxicity risk.
-
Pregnancy & Breastfeeding: Contraindicated risk of teratogenicity and embryo-fetal toxicity. Effective contraception required during and after therapy.
-
Drug Interactions: Increased toxicity with other myelosuppressive drugs (e.g., zidovudine, chemotherapy agents) or nephrotoxic drugs (e.g., cyclosporine, amphotericin B).
-
Route of Use: Only for IV infusion never administer intramuscularly or as IV bolus.