Prepared by: Md. Wahid Rezwan

Sr. Executive, PMD

Chemist Laboratories Ltd.

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

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.

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).

Indications

Iron deficiency Anemia

Patients with Chronic Kidney Disease

Pregnant Woman with Iron deficiency

Patients who cannot tolerate Oral therapy

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

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

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)

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

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

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

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.

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

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

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

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

% 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

% 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

• Worldwide 42% of all Pregnant Woman are Anaemic

• Anaemia causes 25% of all Maternal Death

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

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.

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

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

Children:Not more than 3mg /kgOnce to Three times a Week as IV infusion* Depends on Hemoglobin level

Calculation of Dosage of Nefrofer cont.

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.