CosmoFer

Read all of this leaflet carefully

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, nurse or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor,nurse or pharmacist.

In this leaflet

  • What CosmoFer® is and what it is used for
  • Before you are given CosmoFer®
  • How CosmoFer® is given
  • Possible side effects
  • How CosmoFer® will be stored
  • Further information


CosmoFer® - Iron(lII)-hydroxlde dextran complex

-The active substance is iron(lII)-hydroxide dextran complex 5%, which is equivalent to 50 mg of iron per rnl.
-The other ingredient is water for injection
Imported by: Inspire Pharmaceutical Company, 55, Ahmed El Sawy, Nasr city, Cairo, Egypt
Marketing Authorization Holder: Pharmacosmos A/S, Denmark
Batch releaser: Pharmacosmos A/S, Denmark

What CosmoFer® is and what it is used for

CosmoFer® is a solution of iron(III)-hydroxide dextran complex for injection and infusion.
It will be given to you when you are suffering from iron deficiency anaemia and it is not possible to give iron orally.

Before you are given CosmoFer®

You should not be given CosmoFer®:

  • If you are allergic (hypersensitive) to iron(III)-hydroxide dextran complex or other iron mono- or disaccharide complexes
  • If you have anaemia that is not caused by a lack of iron (haemolyticanaemia)
  • If you have iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis).
  • If you have decompensated liver cirrhosis.
  • If you have infectious hepatitis.

Take special care with CosmoFer®

Please inform the person who is about to give you an injection of CosmoFer® of any medical allergies that you may have, as Iron Dextran Injection can cause severe allergic reactions. Large doses of CosmoFer® (5 ml or more) have been reported to give a brown colour to serum from a blood sample that has been drawn four hours after administration. The drug may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium.

Pregnancy
Ask your doctor or pharmacist for advice before being given CosmoFer® if you are pregnant

Breast-feeding
Ask your doctor or pharmacist for advice before being given CosmoFer® if you are breast-feeding.

Taking other medicines
You should not be given an injection of CosmoFer® if you are also taking other iron supplements. Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those you have bought yoursetf.

How CosmoFer® will be given to you

CosmoFer® can be given to you by an injection or infusion into a vein (intravenously) or injection into a muscle (intramuscularily).
To avoid adverse reactions the injection will be given to you slowly and may be diluted in sodium chloride or glucose solution.
When CosmoFer® is injected directly into the muscle, it is not diluted. CosmoFer® may be given two or three times a week depending on your haemoglobin level. As a precaution a small dose will be given to you to make sure that you have no reactions to it. Provided you show no reaction to this, the remaining dose can be given to you. The normal dosage schedule is 100 to 200 mg iron daily or every other day. You may also be given the complete dose in a single infusion, diluted in saline or glucose. This will be given to you over a period of 4 to 6 hours.

If you are given more Iron Dextran Injection than you should
As a trained person will give you CosmoFer®, it is highly unlikely that you will be given too much. If you think a child or anyone else has accidentally taken any of this treatment, let a hospital casualty department or hospital staff know immediately.

Possible sideeffects

Like all medicines, CosmoFer® can have side effects.

There is a risk of severe allergic reactions (anaphylactoid reactions).
The necessary emergency equipment will be immediately available before you are given Iron Dextran Injection to counter
the effects of this. Other allergic reactions such as difficulty breathing (dyspnoea), flushing, chest pains, and low blood
pressure are also uncommon. The most common side effects are itching of the skin and shortness of breath. Other side
effects, which you may experience, are chest pains, nausea, low blood pressure, enlargement of lymph nodes, upset stomach,diarrhoea, flushing, headache, and pains in your joints and muscles. You may feel some pain and also some inflammation
at the site of injection in addition to some discolouration of the skin. If you notice any side effects not mentioned in this leaflet, please inform the person giving you CosmoFer® or your doctor.

Storing Cosmofer®

It is unlikely that you will be asked to store CosmoFer-yourself, however if you have to please:
Keep out of the reach and sight of children
Store at room temperature
Do not use after the expiry date stated on the carton

Further information

For any information about this medicinal product, please contact the local representative of Pharmacosmos A/S as given below.
Inspire Pharmaceutical Company, 55, Ahmed El Sawy, Nasr city, Cairo, Egypt

Technical Information Leaflet

Name of the medicinal product

CosmoFer®
Iron(III)-Hydroxide dextran complex

Qualitative and quantitative composition
2 ml ampoule containing 100 mg iron(III) as Iron(III)-hydroxide dextran complex
5 ml ampoule containing 250 mg iron(III) as Iron(III)-hydroxide dextran complex
Each ml contains 50 mg Iron (III).

Pharmaceutical form
Solution for injection and for infusion, single dose container

Clinical particulars
Therapeutic indications
CosmoFer® is indicated for the treatment of iron deficiency in the following indications:

  • Demonstrated intolerance to oral iron preparations.
  • Where there is a clinical need to deliver iron rapidly to iron stores
  • Demonstrated lack of effect of oral iron therapy
  • The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Serum ferritin, serum iron, transferrin saturation and hypochromic red cells).

Posology and method of administration
Adults and elderly
The total cumulative dose of CosmoFer® is determined by haemoglobin level and body weight. The dose and dosage schedule for CosmoFer® must be individually estimated for each patient based on a calculation of the total iron deficit.

Children (under 14 years)
CosmoFer® should not nornally be given in the first 4 months of life. The total cumulative dose of CosmoFer® is deternined by haemoglobin level and bodyweight. The dose and dosage schedule for CosmoFer® must be individually estimated for each patient based on a calculation of the total iron deficit.

Dosage:
The normal recommended dosage schedule is 100-200 mg iron corresponding to 2-4 ml, two or three times a week depending on thehaemoglobin level. However CosmoFer® may be administered as a total dose infusion upto a total replacement dose corresponding to 20 mg iron/kg body weight, if dinical circumstances require rapid delivery of iron to the body iron stores.

Administration:
CosmoFer® solution for injection can be administered by an intravenous drip infusion or by a slow intravenous injection or
intramuscular injection. Intravenous drip infusion is the preferred route of administration, as this may help to reduce the risk of hypotensive episodes.

Test dose:
Before administering the first dose to a new patient, a test dose of CosmoFer® corresponding to 25 mg iron or equal to ½ ml solution isrecommanded. If no adverse reactions are seen after 60 minutes, the remaining dose can be given. Anaphylactoid reactions to CosmoFer® are usually evident within a few minutes, and close observation is necessary to ensure recognition. Administration must be stopped immediately if any signs of a hypersensitivity reaction or intolerance are detected at any time during the intravenous administration of CosmoFer®. Facilities for cardia-pulmonary resuscitation including adrenaline (1:1000), corticosteroides and antihistamines must be available when administering CosmoFe®.

Intravenous drip infusion:
CosmoFer® must be diluted only in 0.9% sodium chloride solution (normal saline) or in 5% glucose solution. CosmoFer® in a dose of 100-200 mg iron (2-4ml) may be diluted in 100 ml. The first 25 mg of iron should be infused over a period of 15 minutes. If no adverse reactions occur during this time the remaining portion of the infusion should be given at an infusion rate of not more than 100 ml in 30 minutes.

Intravenous injection:
CosmoFer® may be administered in a dose of 100 – 200 mg iron (2-4 ml) by slow intravenous injection (0.2 ml/min) preferably diluted in 10 – 20 ml 0.9% sodium chloride or 5% glucose solution. Before administering a slow intravenous injection, 25 mg of iron should be injected slowly over a period of 1 to 2 minutes. If no adverse reactions occur within 15 minutes, the remaining portion of the injection may be given.

Total dose infusion:
Immediately before administration the total amount of CosmoFer® required, determined from the dosage table or by calculation, is added aseptically to the required volume, usually 500 ml of sterile normal sodium chloride or 5% glucose solutions. The total amount ofCosmoFer®, up to 20 mg/kg bodyweight, is infused intravenously over 4 – 6 hours. The first 25 mg of iron should be infused over a period of 15 minutes. The patient must be kept under close medical observation during this period. If no adverse reactions occur during this time, then the remaining portion of the infusion should be given. The rate of infusion may be increased progressively to 45 – 60 drops per minute. Patients should be observed carefully during the infusion and for at least 1 hour after completion.
Total Dose Infusion (TDI) has been associated with an increased incidence of adverse reactions, in particular delayed
hypersensitivity–like reactions. The intravenous administration of CosmoFer® by the total dose infusion method should be restricted to hospital use only.

Injection into dialyser:
CosmoFer® may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same
procedures as outlined for intravenous administration.

Intramuscular injection:
The total amount of CosmoFer® required is determined either from the dosage table or by calculation. It is administered undiluted as a series of injections. The volume of each is normally determined by the patient's body weight. Normally 2.0 ml up to a maximum of 4.0 ml. If the patient is moderately active, injections may be given daily into alternate buttocks. In inactive or bedridden patients, the frequency of injections should be reduced to once or twice weekly.
CosmoFer® must be given by deep intramuscular injection to minimise the risk of subcutaneous staining. It should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas. A 20 - 21 gauge needle at least 50 mm long should be used for normal adults. while for small adults a shorter and smaller needle (23 gauge x 32 mm) is used.
The patient should be lying in the lateral position with the injection site uppermost, or standing bearing their weight on the leg opposite the injection site. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. CosmoFer® is injected slowly and smoothly. It is important to wait for a few seconds before withdrawing the needle to allow the muscle mass to accommodate the injection volume. To minimise leakage up the injection track, the patient should be encouraged not to rub the injection site.

Calculation of dose - adults and eldely:

a) Iron replacement in patients with iron deficiency anaemia:
Factors contributing to the formula are shown below. The required dose has to be individually adapted according to the total iron deficit calculated by the following formula – haemoglobin in g/l or mmol/l.

Total dose (mg Fe) - Hb in g/l :
(Body weight (kg) x (target Hb - actual Hb) (g/l) x 0.24) + mg iron for iron stores

The factor 0.24 is derived from the following assumptions:
a) Blood volume 70 ml/kg of body weight ≈ 7% of body weight
b) Iron content of haemoglobin 0.34%
Factor 0.24 = 0.0034 x 0.07 x 1000 (conversion from g to mg).
Total dose (mg Fe) – Hb in mmol/l :
Body weight in kg x (target Hb in mmol/l – actual Hb in mmol/l) x 3.84 + mg iron for iron stores.

The factor 3.84 is derived from the following assumptions:
a) Blood volume 70 ml/kg of body weight ≈ 7% body weight
b) Iron content of haemoglobin 0.34%
c) Factor for conversion from haemoglobin g/l to mmol/l is 0.06205

Factor 3.84 = 0.0034 x 0.07 x 1000 / 0.06205
The table below shows the number of millilitres of CosmoFer® injection solution to be used at various degrees of iron deficiency anaemia.
The figures in the table below are based on a target haemoglobin of 150 g/l or 9.3 mmol/l and iron stores of 500 mg which apply to a body weight exceeding 35 kg. Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. This total iron requirement reflects the amount of iron needed to restore haemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of haemoglobin. It should be remembered that iron deficiency anaemia will not appear until essentially all iron stores have been depleted. Therapy, thus, should aim at not only replenishment of haemoglobin iron but of iron stores as well.
If the total necessary dose exceeds the maximum allowed daily dose, the administration must be split. Evidence of a therapeutic response can be seen within a few days of administration of CosmoFer® as an increase in the reticulocyte count. Serum ferritin levels usually provide a good guide to the replenishment of iron stores. In renal dialysis patients receiving CosmoFer®, this correlation may not be valid.

Total dose of CosmoFer® in Millilitres to beadministered in iron deficiency anaemia

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Haemoglobin content

 

Body weight (kg)

60 g/l ≈ 3.7 mmol/l

75 g/l ≈ 4.7 mmol/l

90 g/l ≈ 5.6 mmol/l

105 g/l ≈ 6.5 mmol/l

120 g/l ≈ 7.4 mmol/l

135 g/l ≈ 8.4 mmol/l

35

25

23

20

18

15

12.5

40

27

24

22

19

16

13

45

29

26

23

20

16.5

13

50

32

28

24

21

17

13.5

55

34

30

26

22

18

14

60

36

32

27

23

18.5

14.5

65

38

33

29

24

19.5

14.5

70

40

35

30

25

20

15

75

42

37

32

26

21

15.5

80

45

39

33

27

21.5

16

85

47

41

34

28

22

16

90

49

42

36

29

23

16.5


Note: The table and accompanying formula are applicable for dose determination only in patients with iron deficiency anaemia.

They are not to be used for dose determination in patients requiring iron replacement for blood loss.
b) Iron replacement for blood loss:
Iron therapy in patients with blood loss should be directed toward replacement of an amount of iron equivalent to the amount of iron represented in the blood loss. The table and formula described are not applicable for simple iron replacement values. Quantitative estimates of the individual’s periodic blood loss and hematocrit during the bleeding episode provide a convenient method of calculation of the required iron dose. The required CosmoFer® dose to compensate the iron deficit is calculated according to the

following formulas:

  • If the volume of blood lost is unknown: The administration of 200 mg i.v. iron (4 ml CosmoFer) results in an increase of haemoglobin which is equivalent to 1 unit blood (= 400 ml with 150 g/l Hb content or 9.3 mmolHb/l – equivalent to 0.34% of 0.4 x 150 or 204 mg iron). Iron to be replaced [mg] = number of blood units lost x 200. Millilitres of CosmoFer® needed = number of blood units lost x 4.
  • If the Hb level is reduced: Use the previous formula considering that the depot iron does not need to be restored. Mg iron to be replaced = body weight (kg) x 0.24 x (target Hb in g/l - actual Hb in g/l).Or Mg iron to be replaced = body weight (kg) x 3.84 x (target Hb in mmol/l – actual Hb in mmol/l). E.g.: body weight 60 kg, Hb deficit = 10 g/l or 0.62 mmol/l: Iron to be replaced = 60 x 0.24 x 10 = 60 x 3.84 x 0.62 = 143 mg (≈ 3 millilitresCosmoFer) Calculation of dose

children up to 14 years

The dosage table can not be used for children due to their lower iron stores. The required dose has to be individually adapted according to the total iron deficit calculated by the following formula -haemoglobin in g/l or mmo/l.
Total dose (mg Fe) -Hb in g/l:
Body weight (kg) x (target Hb -actual Hb) (g/l) x 0.024 =mg Fe (100 mg =2 ml)
Total dose (mg Fe) -Hb in mmol/I:
Body weight (kg) x (target Hb -actual Hb) (mmoVI) x 3.84 =mg Fe (100 mg =2 ml)