MALTOFER SYRUP 50mg5ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

HYDROXIDE POLYMALTOSE COMPLEX EQV IRON

Available from:

VIFOR PHARMA ASIA PACIFIC PTE. LTD.

ATC code:

B03AB05

Dosage:

10mg/ml

Pharmaceutical form:

SYRUP

Composition:

HYDROXIDE POLYMALTOSE COMPLEX EQV IRON 50mg/5ml

Administration route:

ORAL

Prescription type:

General Sale List

Manufactured by:

Vifor SA

Authorization status:

ACTIVE

Authorization date:

1991-04-08

Patient Information leaflet

107160 
Pf 428-00
SYRUP
Pharmaceutical form: oral solution
COMPOSITION
1 ml of syrup contains 10 mg of iron as 
Iron(III)-Hydroxide Polymaltose Complex 
(IPC), flavour ing, sucrose, preservatives 
(E 216, E 218), excip. ad solutionem.
PROPERTIES
Pharmacotherapeutical group: 
Antianaemicum.
ATC Code: B03AB05
Maltofer
®
  syrup  is  an  iron  prepara tion 
for the treatment of latent iron deficien-
cy and iron deficiency anaemia. Iron is 
an important constituent of haemoglo-
bin, myoglobin, and the enzymes which 
contain iron. The treatment of iron defi-
ciency 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 fa tigue, lack of con-
centration,  irritability,  nervousness, 
head ache, 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
®
 syrup is present as 
Iron(III)-Hydroxide  Complex,  where 
indiv id ual particles are embedded in a 
carbohydrate  polymer  (polymaltose). 
This prevents the iron from causing any 
harm  in  the  gastro intestinal  system. 
This  protection  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 
 protein.  Due  to  this  similarity,  iron  is 
absorbed 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 
deficiency). Prophylactic therapy of iron 
deficiency dur

Summary of Product characteristics

2020 -06-17 SG MAL SY PI_v.2
MALTOFER
®
SYRUP
Pharmaceutical form: oral solution
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of syrup contains 10 mg of iron as iron(III)-hydroxide
polymaltose complex (IPC).
Excipients: purified water, sorbitol solution (70%), sucrose, ethanol,
cream essence,
methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and
sodium
hydroxide.
PROPERTIES/EFFECTS
Pharmacotherapeutical group: iron preparation.
ATC Code: B03AB05
_Mechanism of action _
_ _
The polynuclear iron(III) hydroxide core in IPC is surrounded at its
surface by a number
of non-covalently bound polymaltose molecules, which leads to an
average total
molecular weight of around 50 kDa. The polynuclear iron core of IPC
has a structure
similar to that of the physiological iron storage protein ferritin.
IPC is a stable complex
and releases no large quantities of iron under physiological
conditions. Due to its size,
the magnitude of IPC diffusion taking place through the mucosa is
around 40 times less
than
in
most
water-soluble
iron(II)
salts
present
in
aqueous
solution
as
a
hexaaqua-iron(II) complex. Iron is absorbed in the intestines from IPC
through an
active mechanism._ _
_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 iron
stores has been demonstrated in numerous clinical studies in infants,
children,
adolescents and adults. Both solid and liquid galenic forms of IPC
were used in these
studies. The primary goal of an oral iron replacement is to maintain
the body’s own
iron stores within normal limit values (to prevent an iron deficiency,
e.g. in case of
increased requirements), replenish iron stores or correct existing
iron deficiency
anaemia._ _
_Clinical studies in adults _
A total of 11 controlled clinical studies h