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EYEZIRGAN is a brand name for Ganciclovir, supplied as a gel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: EYEZIRGAN (ganciclovir ophthalmic gel) 0.15% is a topical ophthalmic antiviral that is indicated for the treatment of superficial acute herpes simplex keratitis (dendritic ulcers). 1.1 Pediatrics (<18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for…
Verbatim from this product's HC label. Tap a section to expand.
1 Pregnant Women 06/2024 PATIENT MEDICATION INFORMATION 06/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 4 5 OVERDOSAGE..............................................................................................................
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1 Adverse Reaction Overview Ganciclovir ophthalmic gel was studied in a total of 218 patients in three Phase 2 studies and one Phase 3 study over treatment periods of 0-28 days. 5 mg/g ganciclovir and 157 were treated with acyclovir 3%.
The most commonly reported treatment-emergent adverse events were related to eye disorders (eye irritation (burning and stinging), blurred vision, superficial punctuate keratitis and conjunctival hyperaemia). There were no serious adverse reactions reported in clinical trials.
In the post-marketing setting, the following serious adverse reactions have been reported: leukopenia, thrombocytopenia, eye irritation, eye pain, eye swelling, keratitis, blurred vision and corneal abrasion. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The clinical safety of EYEZIRGAN has been evaluated in a total of 4 clinical trials (three Phase 2 studies and one Phase 3 study) performed in patients with dendritic or geographic herpetic keratitis.
The incidence of treatment-emergent adverse reactions reported at any time during treatment with EYEZIRGAN or the active control acyclovir ophthalmic ointment 3% by ≥1% of subjects in Phase 2 and 3 EYEZIRGAN (ganciclovir) Page 8 of 20 trials is presented in Table 1.
1 Pregnant Women 06/2024 PATIENT MEDICATION INFORMATION 06/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 4 5 OVERDOSAGE..............................................................................................................
4 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 7 8 ADVERSE REACTIONS ..................................................................................................
8 9 DRUG INTERACTIONS .................................................................................................. 9 10 CLINICAL PHARMACOLOGY .........................................................................................
10 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 11 PART II: SCIENTIFIC INFORMATION .......................................................................................
12 13 PHARMACEUTICAL INFORMATION ............................................................................ 12 14 CLINICAL TRIALS ........................................................................................................
• EYEZIRGAN is contraindicated in patients who are hypersensitive to ganciclovir, valganciclovir, acyclovir or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ganciclovir in Canada.
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0 a Pooled Phase 2 and 3 clinical trials b The active control used in clinical trials was acyclovir 3% ophthalmic ointment; this formulation of acyclovir is not approved for use in Canada. 5 Post-Market Adverse Reactions The following serious post-market adverse drug reactions have been reported following use of ganciclovir ophthalmic ointment.
Blood and lymphatic system disorders:
Leukopenia, Thrombocytopenia Eye disorders: Eye pain, Eye swelling, Corneal abrasion, Lacrimation increased Gastrointestinal disorders: Ascites General disorders and administration site conditions: Application site pain Immune system disorders: Renal transplant failure Infections and infestations: Pathogen resistance, Pseudomonas infection Investigations: Coma scale abnormal, Liver function test abnormal, Viral load increased, White blood cell increased Nervous system disorders: Balance disorder, Cerebrovascular accident, Headache, Hepatic encephalopathy Psychiatric disorders: Confusional state
13 15 MICROBIOLOGY ........................................................................................................ 14 16 NON-CLINICAL TOXICOLOGY .....................................................................................
15 PATIENT MEDICATION INFORMATION .................................................................................. 15% is a topical ophthalmic antiviral that is indicated for the treatment of superficial acute herpes simplex keratitis (dendritic ulcers).
1 Pediatrics (<18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 CONTRAINDICATIONS • EYEZIRGAN is contraindicated in patients who are hypersensitive to ganciclovir, valganciclovir, acyclovir or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing see 6 DOSAGE FORMS, STRENGTHS, […]