Download - Iron Sucrose
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Prepared by: Md. Wahid Rezwan
Sr. Executive, PMD
Chemist Laboratories Ltd.
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PresentationPresentation
Brand Name : Nefrofer Generic Name : Iron Sucrose BP Therapeutic Class : Hematinic Strength : 5ml Composition : 100mg Elementary
Iron per 5ml Dosage Form : Injection Trade Price : Tk. 270 Maximum Retail Price : Tk. 325
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Each Box contains:
1 Amber ampoule of 5ml Iron Sucrose 100ml Normal Saline 1 Infusion Set 1 Disposable Syringe 1 Alcohol Pad 1 First Aid Band
Presentation cont.Presentation cont.
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GENERAL INFORMATION:
• Nefrofer injection is an iron replacement product for intravenous use. Each ml contains 20 mg elemental iron as iron sucrose in water for injection.
• The drug contains approximately 30% sucrose w/v (300 mg/ml).
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Indications
Iron deficiency Anemia
Patients with Chronic Kidney Disease
Pregnant Woman with Iron deficiency
Patients who cannot tolerate Oral therapy
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Iron
Roles of Iron in Human Body:• Formation of Haemoglobin• Transport of oxygen to body cells• Formation of Myoglobin• Transport of oxygen to muscle cells• DNA Synthesis• Electron transport
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Recommended Dietary Allowance
Group RDA
Infants (0 to 6 months) 6 mg
Infants (6 months to 1 year) 4–10 mg
Children (1 to 10 years) 10 mg
Boys (11 to 18 years) 12 mg
Men (19+ years) 10 mg
Women (11 to 50 years) 15 mg
Women (50+ years) 10 mg
Pregnant women 30 mg
Breastfeeding women 15 mg
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Daily Loss Requirement Total Loss for Growth Urine, skin, Faeces, etc. menses
Infant (0-4 months) 0.5 0.5 (5-12months) 0.5 0.5 1.0Child 0.5 0.5 1.0Adolescent male 0.9 0.9 1.8Adolescent female 0.9 1.0 0.5 2.4Menstruating female 0.9 1.9 2.8Adult male 0.9 0.9Post menopausal female 0.9 0.9
Daily iron losses (mg)
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References Standard of Blood
IronTotal Body Iron:• Men : 3.8 g • Women : 2.3 g
In Blood:• Men : 50-175 mcg/dL or 8.9-31.3 mcmol/L• Women : 40-150 mcg/dL or 7.2-26.8 mcmol/L
Hemoglobin• Men: 13.8 to 18.0 g/dL (138 to 180 g/L, or 8.56 to 11.17 mmol/L) • Women: 12.1 to 15.1 g/dL (121 to 151 g/L, or 7.51 to 9.37 mmol/L) • Children: 11 to 16 g/dL (111 to 160 g/L, or 6.83 to 9.93 mmol/L) • Pregnant women: 11 to 14 g/dL (110 to 140 g/L, or 6.83 to 8.69 mmol/L
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Ferritin (Ferritin is a protein that stores iron and releases it in a controlled fashion)
References Standard cont.
Men 18-270 nanograms per milliliter (ng/mL) or 18-270 micrograms per liter (mcg/L)
Women 18-160 ng/mL or 18-160 mcg/L
Children (6 months to 15 years) 7-140 ng/mL or 7-140 mcg/L
Infants (1 to 5 months) 50-200 ng/mL or 50-200 mcg/L
Neonates 25-200 ng/mL or 25-200 mcg/L
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Iron Deficiency
Lower levels of iron in the body. • Men < 3.8 g and
• Women < 2.3 g
It is estimated that
Worldwide 60-80% people are suffering from
Iron Deficiency, causing almost one million deaths each year
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Anaemia
Anaemia is a condition that indicates lower than normal levels of red blood cells or haemoglobin in the body that are responsible to carry oxygen around the body.
Low levels of hemoglobin and RBCs cause the blood supply insufficient amounts of Oxygen to the tissues that create various problems in the body.
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How Red Blood Cell are Produced
Anemia Effects video - Animation by Cal Shipley, M.D. Trial Image Inc. (SD).mp4
How Red Blood Cells are produced Erythropoiesis (SD).mp4
Effect of Hemoglobin in Anaemia
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Causes of Anaemia
• An iron-poor diet, especially in infants, children, teens, vegans, and vegetarians
• The metabolic demands of pregnancy and breastfeeding that deplete a woman's iron stores
• Menstruation
• Frequent blood donation
• Endurance training• Digestive conditions such as Cron’s disease or surgical
removal of part of the stomach or small intestine• Certain drugs, foods, and caffeinated drinks
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Symptoms of Anaemia
• Weakness
• Headache• Irritability• Fatigue• Difficulty exercising• Unusually rapid heart beat, particularly with exercise
• Shortness of breath and headache, particularly with exercise• Difficulty concentrating• Dizziness• Leg cramps• Insomnia
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Diagnosis of Anaemia
WHO's Hemoglobin thresholds used to define anemia (1 g/dL = 0.6206 mmol/L)
Age or gender group Hb threshold (g/dl) Hb threshold (mmol/l)
Children (0.5–5.0 yrs) 11.0 6.8
Children (5–12 yrs) 11.5 7.1
Teens (12–15 yrs) 12.0 7.4
Women, non-pregnant (>15yrs)
12.0 7.4
Women, pregnant 11.0 6.8
Men (>15yrs) 13.0 8.1
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% of Anemia prevalence in Different Areas of Bangladesh, 2004
61.1
5052.9
5055.6
52.355.2
5154.3
39.2
52.9
60.8
39.5
29.936 33.1
39.735.6
79.673.9
66.8 64.8
71.8
79.9
B aris al C hittag ong Dhaka K hulna R ajs hahi S y lhet
P reg nant Women Non P reg nant Women Adoles c ent C hildren
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% of Anaemia Prevalance in different age groups
47.4
25.4
41.8
30.2
12.7
23.9
0
5
10
15
20
25
30
35
40
45
50
P res c hool-ag echildren
S chool-ag echildren
P reg nant women Non-preg nantwomen
Men E lderly
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• Worldwide 42% of all Pregnant Woman are Anaemic
• Anaemia causes 25% of all Maternal Death
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Calculation of Dosage of Nefrofer
Total Iron Deficit (mg)
Nefrofer (ml) =
20mg/ml
Total Iron Deficit (mg) =
Body weight (kg) x (Target Hb – Actual Hb) [g/l] x 0.24* + Depot Iron
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Total Iron Deficit (mg) = Body weight (kg) x (Target Hb – Actual Hb) [g/l] x 0.24* + Depot iron
Up to 30kg body weight:
Target Hb = 130 g/l & Depot Iron = 15 mg/kg body weight
Above 30kg body weight:
Target Hb = 150 g/l & Depot Iron = 500 mg
Calculation of Dosage of Nefrofer cont.
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Calculation of No. of Ampoules required
Hb Level
5 kg
10 kg
15 kg
20 kg
25 kg
30 kg
35 kg
40 kg
45 kg
50 kg
55 kg
60 kg
65 kg
70 kg
75 kg
80 kg
85 kg
90 kg
Hb 60 g/l
1.5 3 5 6.5 8 9.512.5
13.5
15 16 17 18 19 20 2122.5
23.5
24.5
Hb 75 g/l
1.5 3 4.5 5.5 7 8.511.5
12 13 14 15 1616.5
17.5
18.5
19.5
20.5
21.5
Hb 90 g/l
1.5 2.5 3.5 5 6 7.5 10 11.5
11.5
12 13 13.5
14.5
15 16 16.5
17 18
Hb 105 g/l
1 2 3 4 5.5 6.5 9 10 1010.5
1111.5
1212.5
1313.5
1414.5
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If quantity of blood lost is known:
1 Unit Blood = 5ml x 2 = 200mg IV Iron
Iron to be replaced (mg) = Number of blood unit lost x 200
Amount of Nefrofer needed (ml) = Number of blood unit lost x 10 x 2
Calculation of No. of Ampoules required -2
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Children:Not more than 3mg /kgOnce to Three times a Week as IV infusion* Depends on Hemoglobin level
Calculation of Dosage of Nefrofer cont.
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Situation AnalysisMarket Size MAT Sales Cr LC
MAT Share %
MAT Gr %
Total Pharma Market 9388.69 100 13.5
Iron Sucrose 11.18 93.81 37.65
Brand Company Saline MAT Sales Cr LC
MAT Share % MAT Gr. %
Feroven Orion √ 3.09 25.78 16.13
Xenofer Beacon X 2.19 19.66 -5.78
Hemofer Popular √ 1.76 15.75 94.97
Veniron Beximco X 1.33 12.36 115.12
Kidifer General √ 1.64 10.76 999
Inofer Aristopharma X 0.58 5.72 19.75
Nefrofer Chemist √ 27.83 Lkh. 2.5
2013 32.74 Lkh.
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