Inofar – IV Injection or Infusion 100 mg/pcs

৳  300.00

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Generic Name: Iron Sucrose
Therapeutic class: Haematinics (Haematinics)
Manufacturer :Aristopharma Ltd

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Indications

This is indicated for the treatment of Iron deficiency in the following indications:

  • Where there is a clinical need for a rapid Iron supply
  • In patients who can not tolerate oral Iron therapy or who are non-compliant
  • In active inflammatory bowel disease where oral Iron preparations are ineffective
  • Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
  • Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
  • Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
  • Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin
  • It is also indicated in the treatment of Iron deficiency anaemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.

Dosage & Administration

Adults and Elderly: 5-10 ml Iron Sucrose Injection (100-200 mg Iron) once to three times a week depending on the hemoglobin level.

Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Iron Sucrose Injection (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.

Side Effects

  • Adverse reactions, whether or not related to Iron Sucrose injection are as follows: hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron.
  • Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders
  • General: hypotension, chest pain, hypertension, hypervolemia.
  • Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes.
  • Central and Peripheral Nervous System: dizziness.
  • Musculoskeletal System: cramps/leg cramps, musculoskeletal pain.
  • Respiratory System: dyspnea pneumonia, cough.
  • Skin and appendages: pruritus, application site reaction.
  • Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with Iron Sucrose administration can occur. So, patients should be given a small test dose initially.

Pregnancy & Lactation

Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.

Precautions & Warnings

General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained 48 hours after IV dosing.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies.

Hypotension: Hypotension has been reported frequently in hemodialysis patients receiving intravenous Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron Sucrose according to recommended guidelines.

Use in Special Populations

Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.

Geriatric Use
: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.Injection into dialyser: Iron Sucrose Injection may be administered directly into the venous limb of the dialyser under the same conditions as for intravenous injection.Hemodialysis Dependent-Chronic Kidney Disease Patients (HDD-CKD): Iron Sucrose Injection may be administered undiluted as a 100 mg slow intravenous injection over 2 to 5 minutes or as an infusion of 100 mg, diluted in a maximum of 100 ml of 0.9% NaCI over a period of at least 15 minutes per consecutive hemodialysis session for a total cumulative dose of 1,000 mg.Non-Dialysis Dependent-Chronic Kidney Disease Patient (NDD-CKD): Iron Sucrose Injection is administered as a total cumulative dose 1000 mg over a 14 day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within the 14 day period.

Overdose Effects

Dosages of Iron Sucrose Injection in excess of Iron needs may lead to accumulation of Iron in storage sites leading to hemosiderosis. Periodic monitoring of Iron parameters such as serum ferritin and transferrin saturation may assist in recognizing Iron accumulation. Iron Sucrose should not be administered to patients with Iron overload and should be discontinued when serum ferritin levels equal or exceed established guidelines. Particular caution should be exercised to avoid Iron overload where anaemia unresponsive to treatment has been incorrectly diagnosed as Iron deficiency anaemia. Symptoms associated with overdosage or infusing Iron Sucrose too rapidly included hypotension, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema. and cardiovascular collapse. Most symptoms have been successfully treated with IV fluids, hydrocortisone, and/or antihistamines. Infusing the solution as recommended or at a slower rate may also alleviate symptoms.

Therapeutic Class

Parenteral Iron Preparations

Storage Conditions

Store in a cool (15°C- 30°C) & dry place, protected from light. Keep out of the reach of children. Do not freeze.

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Inofar IV Injection or Infusion 100 mg 5 ml Aristopharma Ltd.

Inofar - IV Injection or Infusion 100 mg/pcs

৳  300.00

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