AVOFER INJECTION 100MG/5ML

NANG KUANG PHARMACEUTICAL CO., LTD., (TAIWAN)🇸🇬 Health Sciences Authority

Approval Date: Jun 16, 2022
Approval ID: 5835f84749f930d7
Company: NANG KUANG PHARMACEUTICAL CO., LTD., (TAIWAN)
Type: Therapeutic

Approval Details

Approval Id: 5835f84749f930d7
Drug Name: AVOFER INJECTION 100MG/5ML
Product Name: AVOFER INJECTION 100MG/5ML
Approval Number: SIN16513P
Approval Date: 2022-06-16
Registrant: APEX PHARMA MARKETING PTE. LTD.
Licence Holder: APEX PHARMA MARKETING PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: POSOLOGY AND METHOD OF ADMINISTRATION Calculation of Dosage Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of Avofer. Avofer 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. Posology The cumulative dose of Avofer must be calculated for each patient individually and must not be exceeded. Calculation of dosage The total cumulative dose of Avofer, equivalent to the total iron deficit (mg), is determined by the haemoglobin level (Hb) and body weight (BW). The dose of Avofer must be individually calculated for each patient according to the total iron deficit calculated with the following Ganzoni formula, for example: <img src="/TGIF/Avofer-Formula1.png" alt="Avofer Dosage Formula 1" /> <img src="/TGIF/Avofer-Formula2.png" alt="Avofer Dosage Formula 2" /> <img src="/TGIF/Avofer-Table1.png" alt="Avofer Dosage Table 1" /> To convert Hb (mM) to Hb (g/dl), multiply the former by 1.6. If the total necessary dose exceeds the maximum allowed single dose, then the administration must be divided. If no response of the haematological 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 Avofer dose to compensate for the iron deficit may be calculated according the following formulas: If the quantity of blood lost is known: The administration of 200 mg iron (10 ml of Avofer) should result in an increase in Hb approximately equivalent to 1 unit blood (400 ml with Hb = 15 g/dl). <img src="/TGIF/Avofer-Formula3.png" alt="Avofer Dosage Formula 3" /> If the Hb level is less than desired: Formula assumes that the storage iron does not need to be restored. Iron to be replaced [mg] = BW [kg] x 2.4 x (target Hb – actual Hb) [g/dl] <img src="/TGIF/Avofer-Image1_191022.png" alt="Avofer Dosage Image 1" /> For the maximum tolerated single and weekly dose, see “Normal posology” and “Maximum tolerated single and weekly doses”. Normal Posology Adult: 5–10ml of Avofer (100–200 mg iron) 1 to 3 times a week. For administration time and dilution ratio see “Method of administration”. Paediatric population There is moderate amount of data in children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml of Avofer (3 mg iron) per kg body weight not more than three times per week. For administration time and dilution ratio see “Method of administration”. Maximum tolerated single and weekly doses Adults As an injection, maximum tolerated dose per day given not more than 3 times per week: ➢ 10 ml of Avofer (200 mg iron) injected over at least 10 minutes As an infusion, maximum tolerated dose per day given not more than once per week: ➢ Patients above 70 kg body weight: 500 mg iron (25 ml of Avofer) over at least 3 ½ hours ➢ Patients of 70 kg body weight and below: 7 mg iron/kg body weight over at least 3 ½ hours The infusion times given in “Method of administration” should be strictly adhered to, even if the patient does not receive the maximum tolerated single dose. Method of Administration Avofer must only be administered by the intravenous route. This may be by drip infusion, slow injection or directly into the venous line of the dialysis machine. <ol class="decimalparen"> <li>Intravenous drip infusion Avofer must only be diluted in sterile 0.9% m/V sodium chloride (NaCl) solution. Dilution must take place immediately prior to infusion and the solution should be administered as follows: <img src="/TGIF/Avofer-Table2.png" alt="Avofer Dosage Table 2" /> </li> <li>Intravenous Injection Avofer may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute and not exceeding 10 ml (200 mg iron) per injection.</li> <li>Injection into venous line of dialysis machine Avofer may be administered during haemodialysis session directly into the venous line of the dialysis machine under the same conditions as for intravenous injection.</li> </ol>
Route Of Administration: INTRAVENOUS
Indication Info: INDICATIONS Avofer is indicated in 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 ➢ Where oral iron preparations are ineffective (e.g., in active inflammatory bowel disease). Avofer should only be administered where the indication is confirmed by appropriate investigations.
Contraindications: CONTRAINDICATIONS The use of Avofer is contraindicated in the following conditions: <ul> <li>Hypersensitivity to iron sucrose, Avofer or to any of its excipients listed in section List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</li> <li>Anaemia not caused by iron deficiency</li> <li>Evidence of iron overload or disturbances in utilisation of iron</li> <li>Pregnancy first Trimester</li> </ul>
Atc Code: B03AC
Atc Item Name: 非肠道用药的三价铁制剂
Pharma Manufacturer Name: APEX PHARMA MARKETING PTE. LTD.

Active Ingredients

IRON (III) HYDROXIDE SUCROSE COMPLEX EQV IRON (III)

100 MG/5 ML

Iron (III) Hydroxide Sucrose complex eqv Iron (III)

100mg/5ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 16, 2022

Approval ID

5835f84749f930d7

Type

Therapeutic

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