Venofer 100 mg/5 ml (IV Injection or Infusion)

Indications

• Treatment of Venofer deficiency
• Rapid Venofer supply
• Inflammatory bowel disease treatment
• Chronic kidney disease treatment
• Treatment for surgical procedures
• Anemia treatment

Pharmacology

• Therapeutic class: haematinic
• Sterile brown aqueous complex
• Approximately 30% Sucrose w/v
• pH of 10.5-11.1
• Dissociated into Iron and Sucrose
• Iron distribution in liver and bone marrow
• Transferrin synthesis increase in Iron deficiency
• Elimination half-life 6h
• Total clearance 1.2 L/h
• Volume distribution in blood and extravascular fluid

Dosage

• Adult dosage: 5-10 ml Iron Sucrose Injection
• Children dosage: not to exceed 0.15 ml Iron Sucrose Injection per kg body weight

Administration

• Intravenous injection
• Slow intravenous injection rate
• Maximum 10 ml Iron Sucrose Injection per injection
• Infusion by drip infusion
• Dilution with 0.9% w/v Sodium Chloride
• Infusion time based on Iron content
• Test dose for new patients

Interaction

• No studied drug-drug interactions
• Avoid concomitant oral iron preparations
• Oral iron therapy should not be given until 5 days after last injection

Contraindications

• Iron overload evidence
• Known hypersensitivity to Iron Sucrose
• Anaemia not caused by Iron deficiency
• History of allergic disorders, liver disease, infections

Side Effects

• Hypotension, cramps, nausea, headache, vomiting, diarrhea
• Various adverse reactions
• Hypersensitivity reactions including anaphylactoid reactions

Pregnancy & Lactation

• Pregnancy Category-B
• Caution during lactation

Precautions & Warnings

• Periodic monitoring of hematologic and haematinic parameters
• Caution for hypersensitivity reactions and hypotension
• Safety and effectiveness in pediatric and geriatric use

Use in Special Populations

• Safety and effectiveness in pediatric patients not established
• Administered directly into the venous limb of the dialyser
• Specific dosages for Hemodialysis Dependent-Chronic Kidney Disease Patients and Non-Dialysis Dependent-Chronic Kidney Disease Patient

Overdose Effects

• Venofer accumulation leading to hemosiderosis
• Symptoms of overdosage or rapid infusion
• Caution to avoid Venofer overload

Therapeutic Class

• Parenteral Iron Preparations

Storage Conditions

• Store in a cool (15°C-30°C) & dry place
• Protected from light
• Do not freeze

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