Gancyclovir for Injection 500mg (1vial/bpx, 10 vials/box)

• Dossier: Ctd
• Transport Package: Free
• Specification: 500mg
• Trademark: Sinolead
• Origin: China
• Model NO.: Powder Injection

Product Description

 

Generic Name	Gancyclovir for Injection 500mg
Strength	500mg
Packing	1vial/box,10 vials/box
Origin	China

Component:
The active ingredient is Ganciclovir sodium salt. Each bottle contains dry powder equivalent to 500 mg of gengenin lovir and approximately 45 mg (2mEq) of sodium.

Character:
This product is freeze-dried powder.

Indications:

For the prevention and treatment of life-threatening or visually impaired patients with CMV infection and for the prevention of organ transplant patients associated with CMV infection.

 

Usage and dosage:

1. Standard dose for treatment of cytomegalovirus retinitis

Induction therapy:

For patients with normal renal function, the dose is 5 mg/kg, and the intravenous infusion is more than 1 hour, repeated every 12 hours for 14 to 21 days.

Maintenance treatment:

The dose is 5 mg/kg intravenously infused for more than 1 hour, once a day, 7 times a week, or 6 mg/kg once a day, 5 times a week.

2. Standard prophylactic dose for organ transplant patients

Induction therapy: patients with normal kidney function, 5 mg/kg, intravenous infusion for more than 1 hour, 1 time /12 hours, a course of 7 to 14 days.

Maintenance treatment: 5 mg/kg, intravenous infusion for more than 1 hour, once a day, 7 times a week; Or 6 mg/kg once a day, 5 times a week.

3. Special medication guidance

Patients with renal insufficiency

Dosage is adjusted according to the table below.

Creatinine clearance can be calculated using serum creatinine according to the following formula.

Male =[140- age (years)× body weight (kg)]/[72×0.011× serum creatinine (μmol/L)];

Female =0.85 x male value.
Serum creatinine levels and creatinine clearance need to be carefully monitored due to dose adjustment in patients with renal insufficiency.

Patients with leukopenia, severe neutropenia, anemia and thrombocytopenia:

Patients receiving ganciclovir may have granulocytopenia (neutropenia), anemia, and thrombocytopenia. Clinical toxicity of ganciclovir includes leukopenia. For those with leukopenia, severe neutropenia, anemia, and/or thrombocytopenia, dose reduction should be considered.

It is recommended that the whole blood count and platelet count be checked frequently.

4. Preparation method of this product solution

Fill 10 ml of water for injection into a sterile vial of dry powder. Do not use water containing parabens(such as parahydroxybenzoates) for bacteria preparation, because these substances are insoluble with the dry powder and precipitate.

Shake to dissolve the medicine.

The preparation solution should be checked for particulates.

The prepared solution can maintain stability at room temperature for up to 12 hours and cannot be frozen for storage.

5. Preparation and usage of injection and infusion

The dosage is calculated according to the patient's body weight, and a certain volume of the preparation solution (concentration 50 mg/ml) is drawn from the bottle, and normal saline, 5% glucose water, Ringer's solution or lactate Ringer's solution is added, and the infusion concentration is recommended not to exceed 10 mg/ml.

This product should not be mixed with other intravenous fluids

Since this product is prepared with non-bacteriogenic sterile water, the injection and infusion should be used within 24 hours to avoid bacterial contamination.

Infusion should be refrigerated, but not stored frozen.

Note: Rapid administration or intravenous infusion should not be done because high plasma concentrations can lead to increased side effects.

Due to the high PH of Ganciclovir solution (pH≈11), intramuscular or subcutaneous injection can cause severe tissue irritation.

The recommended dose, number of uses and infusion speed should not be exceeded.

Precautions:

The following adverse reactions may occur when using this product. The occurrence of some adverse reactions may be related to underlying diseases.

1. Blood and lymphatic system: anemia, eosinopenia, hemoglobinic anemia, leukopenia, bone marrow suppression, various types of hemocytopenia, thrombocytopenia.

2. Gastrointestinal system: abdominal pain, constipation, diarrhea, dyspepsia, dysphagia, belching, fecal incontinence, flatulence, bleeding, abnormal liver function test, mouth ulcer, nausea, pancreatitis, tongue disorder, vomiting.

3, general: abdominal enlargement, anorexia, weakness, cellulitis, chest pain, chills, edema, fever, headache, infection, injection site abscess, injection site edema, injection site bleeding, injection site inflammation, injection site pain, injection site phlebitis, abnormal laboratory examination, general discomfort, pain, light sensitivity, sepsis.

4. Cardiovascular system: arrhythmia, deep thrombosis, phlebitis, hypertension, hypotension, migraine, vasodilation.

5. Respiratory system: Increased cough and difficulty breathing.

6. Central nervous system: abnormal dreams, abnormal gait, anxiety, ataxia, coma, confusion, depression, dizziness, dry mouth, euphoria, hypesthesia, insomnia, manic reactions, tension, paraesthesia, psychosis, seizures, lethargy, tremors.

7. Skin and accessories: acne, hair loss, herpes simplex, maculopapules, pruritus, rash, sweating, urticaria, etc.

8. Special sensation: visual abnormality, amblyopia, blindness, conjunctivitis, deafness, eye pain, glaucoma, retinal detachment, retinitis, palatosis, vitreous disease.

9. Metabolic and nutritional disorders: increased alkaline phosphatase, increased creatinine, decreased blood sugar, low potassium, elevated lactate dehydrogenase, elevated aminotransferase, etc.

10. Genitourinary system: abnormal kidney function, breast pain, reduced creatinine clearance, hematuria, increased hematuria nitrogen, kidney failure, frequency of urination, urinary tract infection.

11. Skeletal muscle system: myalgia, myasthenia.