Indication

HemoferTM 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 cannot 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 anemia in patients undergoing surgical procedures, patients donating blood, postpartum
patients.


Dosage & Administration

Administration: HemoferTM has exclusively to be administered intravenously by drip infusion, by slow injection or directly into the venous limb of the dialyser and is not suitable for intramuscular use and for total dose infusion (TDI), where the full dose of Iron required, representing the patient's total Iron deficit is administered in one complete infusion. Before administration of the first therapeutic dose, a test dose should be given. If any allergic reactions or intolerance occurs during administration, the therapy must be stopped immediately.

 

Intravenous injection: HemoferTM can be administered undiluted by slow intravenous injection at the (normal) recommended rate of 1 ml HemoferTM (20 mg Iron) per minute [5 ml HemoferTM (100 mg Iron) in 2 to 5 minutes]. A maximum of 10 ml HemoferTM (200 mg Iron) can be injected per injection. Before administration of the therapeutic dose in a new patient a test dose of 1 ml HemoferTM (20 mg Iron) in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be injected over 1 to 2 minutes. If no adverse reactions occur within a waiting period of 15 minutes, the remaining portion of the injection can be administered at recommended speed. After an injection the arm of the patient should be extended.

 

Infusion: HemoferTM should preferably be administered by drip infusion (in order to reduce the risk of hypotensive episodes and paravenous injection) in a dilution of 1 ml HemoferTM (20 mg Iron) in max. 20 ml 0.9% w/v Sodium Chloride [5 ml (100 mg Iron) in max. 100 ml 0.9% w/v NaCl e.t.c. up to 25 ml (500 mg Iron) in max. 500 ml 0.9% w/v NaCI]. Dilution must take place immediately prior to infusion and the solution should be administered as follows: 100 mg Iron in at least 15 minutes; 200 mg Iron in at least 30 minutes; 300 mg Iron in at least 1.5 hours; 400 mg Iron in at least 2.5 hours and 500 mg Iron in at least 3.5 hours. For the administration of the maximum tolerated single dose of 7 mg Iron/kg body weight, an infusion time of at least 3.5 hours has to be respected, independently of the total dose.

 

Before administration of the therapeutic dose in a new patient the first 20 mg Iron in adults and in children with a body weight greater than 14 kg and half the daily dose (1.5 mg Iron/kg) in children with a body weight less than 14 kg should be infused over 15 minutes as a test dose. If no adverse reactions occur, the remaining portion of the infusion can be administered at recommended speed.

 

Injection into dialyser: HemoferTM 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): HemoferTM 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% NaCl 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 Patients (NDD-CKD): HemoferTM is administered as a total cumulative dose of 1,000 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.

 

Peritoneal Dialysis Dependent-Chronic Kidney Disease Patients (PDD-CKD): HemoferTM is administered as a total cumulative dose of 1,000 mg in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later. The HemoferTM dose should be diluted in a maximum of 250 ml of 0.9% NaCl.

 

NOTE: Do not mix Iron Sucrose with other medications or add to parenteral nutrition solutions for intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Calculation of Dosage:
The dosage has to be individually adapted according to the total Iron deficit calculated with the following formula:
Total Iron deficit [mg] = body weight [kg] x (target Hb - actual Hb) [g/dl] x 2.4* + depot Iron [mg]
Below 35 kg body weight: target Hb = 13 g/dl resp. depot Iron = 15 mg/kg body weight.
35 kg body weight and above: target Hb = 15 g/dl resp. depot Iron = 500 mg.
*Factor 2.4=0.0034x0.07x10000 (Iron content of hemoglobin 0.34%/Blood volume 7% of body weight/Factor 10000 = conversion from
g/dl to mg/l)
                                                                                              Total Iron deficit [mg]
Total amount of HemoferTM to be administered (in ml) = ---------------------------------------
                                                                                                      20 mg/ml

 

(1 ampoule of HemoferTM corresponds to 5 ml).

 

 

 

Calculation of No. of ampoules required for differtent body weight and different hemoglobin level

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 6 g/dl

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 7.5 g/dl

1.5

3

4.5

5.5

7

8.5

11.5

12

13

14

15

16

16.5

17.5

18.5

19.5

20.5

21.5

Hb 9 g/dI

1.5

2.5

3.5

5

6

7.5

10

11

11.5

12

13

13.5

14.5

15

16

16.5

17

18

Hb 10.5 g/dI

1

2

3

4

5.5

6.5

9

9.5

10

10.5

11

11.5

12

12.5

13

13.5

14

14.5

 

 

If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split. If no response of the
hematological parameters is observed after 1 to 2 weeks the original diagnosis should be reconsidered.
Calculation of dosage for Iron replacement secondary to blood loss and to support autologous blood donation: The required HemoferTM dose
to compensate the Iron deficit is calculated according the following formulas: If the quantity of blood lost is known: The administration of 200
mg IV Iron (=10 ml HemoferTM) results in an increase in hemoglobin which is equivalent to 1 unit blood (= 400 ml with 150 g/l Hb content).
Iron to be replaced [mg] = number of blood units lost x 200 or Amount of HemoferTM needed (ml) = number of blood units lost x 10.

If the Hb level is reduced: Use the previous formula considering that the depot Iron does not need to be restored.
Iron to be replaced [mg] = body weight [kg] x 0.24 x (target Hb-actual Hb) [g/I]
e.g.: body weight 60 kg, Hb deficit = 10 g/I Iron to be replaced 150 mg 7.5 ml HemoferTM needed
Normal Dosage
Adults and the Elderly: 5-10 ml HemoferTM (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 HemoferTM (3 mg Iron) per kg body weight once to three times per week depending on the hemoglobin level.


Precautions

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 hematinic 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 Pregnancy: Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Use in Lactation: 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. 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.


Product Details


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