Avofer

Avofer Dosage/Direction for Use

iron sucrose

Manufacturer:

Abio

Distributor:

Apex
Full Prescribing Info
Dosage/Direction for Use
Calculation of Dosage: The total cumulative dose of Avofer, equivalent to the total iron deficit (mg) is determined by the haemoglobin level and body weight. The dose for the Avofer must be individually determined for each patient according to the total iron deficit calculated with the formula as follows: (See Equation 1.)

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Below 35 kg body weight: target Hb ~ 130 g/1 and depot iron - 15 mg/kg body weight.
35 kg body weight and above: target Hb ~ 150 g/1 and depot iron= 500mg.
* Factor 0.24 - 0.0034 x 0.07 x l000.
(Iron content of haemoglobin ~0.34%; Blood volume ~7% of body weight; Factor 1000 = conversion from g/1 to mg/I). (See Equation 2.)

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Alternatively, the total amount of Avofer Injection required in ml is determined from the following formula or dosage table. (See table.)

Click on icon to see table/diagram/image

To convert Hb (mM) to Hb (g/l), multiply the former by 16.1145.
Example: For a patient of 60 kg body weight with an actual Hb of 60 g/190 ml should be administered. (Alternatively 18 vials of5 ml should be administered.)
Normal Posology: Adults and the elderly: 5-10ml of Avofer (100-200 mg iron) one to three times a week depending on the haemoglobin level.
Children: There is limited data on children under study conditions. If there is clinical need, it is recommended not to exceed 0.15ml Avofer (3mg iron) per kg body weight one to three times per week depending on the haemoglobin level.
Method of Administration: Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Avofer Injection.
Avofer Injection should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each Avofer Injection.
Avofer Injection must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Avofer Injection must not be used for intramuscular injection.
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 Drip Infusion: Iron (III) hydroxide Sucrose Injection must be diluted only in sterile 0.9% m/v sodium chloride solution: 5 ml Avofer lnjection (100mg iron) in maximum 100 ml sterile 0.9% m/v sodium chloride solution.
25 ml Avofer Injection (500 mg iron) in maximum 500 ml sterile 0.9% m/v sodium chloride solution.
For stability reasons, dilutions to lower Avofer Injection concentrations are not permissible.
Dilution must take place immediately prior to infusion and the solution should be administered as follow: 100 mg iron (5ml Avofer) in at least 15 minutes.
200 mg iron (10ml Avofer) in at least 30 minutes.
300 mg iron (15ml Avofer) in at least 1 ½ hours.
400 mg iron (20ml Avofer) in at least 2 ½ hours.
500mg iron (25ml Avofer) in at least 3 ½ hours.
As intravenous infusion, maximum tolerated single dose per day given not more than once per week: Patient above 70kg : 500mg iron (25ml Avofer) in at least 3 ½ hours.
Patient of 70kg and below: 7mg iron/kg body weight in at least 3 ½ hours.
The maximum tolerated single dose is 7 mg iron per kg body weight given once per week, but not exceeding 500 mg iron.
Intravenous Injection: Avofer can be administered undiluted by slow intravenous injection as follow: 100 mg iron (5ml Avofer) in at least 5 minutes.
200 mg iron (10ml Avofer) in at least 10 minutes.
As intravenous injection, the maximum tolerated single dose per day is 200mg, given not more than three times per week at injection rate of 1 ml undiluted solution per minute.
200mg iron (10 ml Avofer) injected over at least 10 minutes.
Injection into dialyzer: Avofer may be administered during haemodialysis session directly into the venous limb of the dialyzer under the same condition as for intravenous injection.
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