Monofer

Monofer

iron isomaltoside 1000

Manufacturer:

Pharmacosmos

Distributor:

DCH Auriga

Marketer:

Compai Pharma
Concise Prescribing Info
Contents
Ferric derisomaltose [formerly known as Fe (III) isomaltoside 1000]
Indications/Uses
Fe deficiency where there is a clinical need to deliver Fe rapidly or when oral Fe is ineffective or cannot be used.
Dosage/Direction for Use
Cumulative dose: Up to 2,000 mg should be considered based on body Fe deficit. IV bolus inj Up to 500 mg administered at rate 250 mg/min up to 3 times wkly. IV drip infusion Cumulative dose: Up to 20 mg/kg single infusion. Doses up to 1,000 mg should be given >15 min; doses >1,000 mg should be given ≥30 min for not more than once wkly. HD patient May be given directly into venous limb of dialyser. Therapeutic response can be seen w/in few days.
Contraindications
Hypersensitivity to other parenteral Fe products. Non-Fe deficiency anaemia (eg, haemolytic anaemia), Fe overload or disturbances in Fe utilisation (eg, haemochromatosis, haemosiderosis), decompensated liver cirrhosis, hepatitis.
Special Precautions
Hypersensitivity. Not to be used in patients w/ ongoing bacteraemia. History of severe asthma, eczema or other atopic allergy. Patients w/ immune or inflammatory conditions eg, SLE, RA; acute or chronic infection. Avoid too rapid IV inj. 1st trimester of pregnancy. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Uncommonly, blurred vision, numbness, dysphonia; dyspnoea; nausea, emesis, abdominal pain, constipation; flushing, pruritus, rash; cramps; anaphylactoid reactions, feeling hot, fever, soreness, inflammation near inj site, local phlebitic reaction.
Drug Interactions
Reduced oral Fe absorption. Falsely elevated values of serum bilirubin & falsely decreased values of serum Ca.
ATC Classification
B03AC - Iron, parenteral preparations ; Used in the treatment of anemia
Presentation/Packing
Form
Monofer soln for inj 100 mg/mL
Packing/Price
10 mL x 2 × 1's;5 mL x 5 × 1's
/malaysia/image/info/monofer soln for inj 100 mg-ml/100 mg-ml x 10 ml?id=532ceda8-06eb-4ec2-b244-a9d10087fd87
/malaysia/image/info/monofer soln for inj 100 mg-ml/100 mg-ml x 5 ml?id=86625578-9968-4c4b-adcc-a9d10087fd87
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