Country: Сингапур
Језик: Енглески
Извор: HSA (Health Sciences Authority)
IRON HYDROXIDE POLYMALTOSE EQV IRON
VIFOR PHARMA ASIA PACIFIC PTE. LTD.
B03AB05
50 mg/ml
SOLUTION
IRON HYDROXIDE POLYMALTOSE EQV IRON 50 mg/ml
ORAL
General Sale List
VIFOR SA
ACTIVE
1991-04-08
107157 Pf 427-00 DROPS Pharmaceutical form: oral solution COMPOSITION 1 ml (20 drops) contains 50 mg of iron as Iron(III)-Hydroxide Poly maltose Complex (IPC), flavouring, sucrose, preservatives (E 217, E 219), excip. ad solutionem. PROPERTIES Pharmacotherapeutical group: Antianaemicum. ATC Code: B03AB05 Maltofer ® drops is an iron prepara tion for the treatment of latent iron deficiency and iron deficiency anaemia. Iron is an important constituent of haemoglobin, myoglobin, and the enzymes which con- tain iron. The treatment of iron deficiency in infants up to one year of age is of extreme importance. Iron deficiency at this age can impair the development of the brain. In general, iron deficiency can cause chronic fatigue, lack of concentra- tion, irritability, nervousness, headache, loss of appetite, susceptibility to stress and infection, pale ness, cracks at the corners of the mouth (rhagades), dry skin, brittle hair and nails as well as loss of interest in play in children. The iron in Maltofer ® drops is present as Iron(III)-Hydroxide Complex, where indi- vi d ual particles are embedded in a car- bohydrate polymer (polymaltose). This prevents the iron from causing any harm in the gastro intestinal system. This pro- tection inhibits interactions of the iron with food. Moreover, it ensures the bio- availability of the iron. The structure of IPC is similar to ferritin, the naturally occurring iron storage pro- tein. Due to this similarity, iron is ab - sorbed through natural mechanisms. IPC has no pro-oxidative properties such as there are with bivalent iron salts. INDICATIONS Treatment of latent iron deficiency and iron deficiency anaemia (manifest iron def Прочитајте комплетан документ
2020-06-17 SG MAL DR PI_v.2 MALTOFER® DROPS Pharmaceutical form: oral solution Qualitative and quantitative composition1 ml (20 drops) contains 50 mg of iron as iron(III)-hydroxide polymaltose complex (IPC). Excipients: purified water, sucrose, cream essence, sodium methyl hydroxybenzoate (E219), sodium propyl hydroxybenzoate (E217) and sodium hydroxide. PROPERTIES/EFFECTS Pharmacotherapeutical group: iron preparation. ATC Code: B03AB05 Maltofer® drops are an iron preparation for the treatment of iron deficiency without anaemia and iron deficiency anaemia. Iron is an important constituent of haemoglobin, myoglobin, and iron-containing enzymes. In general, iron deficiency can cause chronic fatigue, lack of concentration and reduced mental performance, irritability, anxiety, headache, loss of appetite, susceptibility to infection, conspicuous paleness, cracks at the corners of the mouth (rhagades), dry skin and brittle hair and nails. In the iron(III)-hydroxide polymaltose complex, the polynuclear iron(III)-hydroxide core is superficially surrounded by a number of non-covalently bound polymaltose molecules resulting in an overall average molecular weight of approximately 50 kDa. The polynuclear core of IPC has a structure similar to that of the physiological iron storage protein, ferritin. IPC is a stable complex and does not release large amounts of iron under physiological conditions. Because of its size, the extent of diffusion of IPC through the membrane of the mucosa is about 40 times less than that of the hexaquo-iron(II) complex. Iron from IPC is taken up in the gut via an active mechanism. In contrast to iron(II) salts, IPC does not have pro-oxidative properties. _Pharmacodynamics _ The iron absorbed is bound to transferrin and is used for Hb synthesis in the bone marrow or stored primarily in the liver bound to ferritin. _Clinical Efficacy _ The efficacy of Maltofer compared to a placebo or similar preparations with different iron formulations in terms of normalising haemoglobin values and replenishing i Прочитајте комплетан документ