Iron Sucrose

Iron Sucrose Injection

2. Prepared by:
Md. Wahid Rezwan
Sr. Executive, PMD
Chemist Laboratories Ltd.

3. Presentation Presentation
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

4. 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.

5. 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).

6. Indications
Iron deficiency Anemia
Patients with Chronic Kidney Disease
Pregnant Woman with Iron deficiency
Patients who cannot tolerate Oral therapy

7. 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

8. 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

9. 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 1.0
Child 0.5 0.5 1.0
Adolescent male 0.9 0.9 1.8
Adolescent female 0.9 1.0 0.5 2.4
Menstruating female 0.9 1.9 2.8
Adult male 0.9 0.9
Post menopausal female 0.9 0.9
Daily iron losses (mg)

10. References Standard of Blood
 Iron
Total 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

11.  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

12. 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

13. 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.

14. 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

15. 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

16. 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

17. Diagnosis of Anaemia
WHO's Hemoglobin thresholds used to define anemia
(1 g/dL = 0.6206 mmol/L)
Age or gender groupHb 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

19. % of Anemia prevalence in Different Areas
of Bangladesh, 2004
61.1
50
52.9
50
55.6
52.3
55.2
51
54.3
39.2
52.9
60.8
39.5
29.9
36
33.1
39.7
35.6
79.6
73.9
66.8
64.8
71.8
79.9
B aris al C hittagong Dhaka K hulna Rajs hahi S ylhet
P reg nant Women Non P reg nant Women Adoles c ent C hildren

20. % 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
Preschool-age
children
S chool-age
children
Preg nant womenNon-pregnant
women
Men E lderly

21. •Worldwide 42% of all Pregnant Woman
are Anaemic
•Anaemia causes 25% of all Maternal
Death

22. 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

23. 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.

24. 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 9.5
12.
5
13.
5
15 16 17 18 19 20 21
22.
5
23.
5
24.
5
Hb 75
g/l
1.5 3 4.55.5 7 8.5
11.
5
12 13 14 15 16
16.
5
17.
5
18.
5
19.
5
20.
5
21.
5
Hb 90
g/l
1.52.53.5 5 6 7.510
11.
5
11.
5
12 13
13.
5
14.
5
15 16
16.
5
17 18
Hb 105
g/l
1 2 3 4 5.56.5 9 10 10
10.
5
11
11.
5
12
12.
5
13
13.
5
14
14.
5

25. 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

26. Children:
Not more than 3mg /kg
Once to Three times a Week as IV infusion
* Depends on Hemoglobin level
Calculation of Dosage of
Nefrofer cont.

27. Situation Analysis
Market 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.