Saferon Syrup

Valsts: Malaizija

Valoda: angļu

Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
26-11-2020

Aktīvā sastāvdaļa:

Iron (111) Hydroxide polymaltose

Pieejams no:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

SNN (starptautisko nepatentēto nosaukumu):

Iron (111) Hydroxide polymaltose

Vienības iepakojumā:

150ml mL; 30 ml mL

Ražojis:

GLENMARK PHARMACEUTICALS LTD

Produkta apraksts

                                PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
foodstuff components (phytin, oxalates, tannin, etc.) and concomitant
administration of medicaments
(tetracyclines, antacids) is unlikely to occur. SAFERON SYRUP does not
cause teeth staining.
The haemoccult-test (selective for haemoglobin) for the detection of
occult blood is not impaired and
therefore iron therapy must not be interrupted.
RECOMMENDED DOSAGE
Dosage and duration of therapy are dependent upon the extent of iron
deficiency.
The daily dose can be divided into separate doses or can be taken at
one time. SAFERON SYRUP should
be taken during or immediately after a meal.
In cases of manifest iron deficiency the therapy takes 3 - 5 months
until a normalisation of the
haemoglobin value is achieved. Afterwards the therapy should be
continued for several weeks with a
dosage such as described for latent iron deficiency to replenish the
iron stores.
OVERDOSAGE
In case of overdose neither intoxication nor iron overload have been
reported.
DOSAGE FORMS AVAILABLE & STRENGTH
Syrup: 50mg/5ml
Chewable Tablets: 100mg/ tablet
STORAGE CONDITIONS
O
Store below 25 C. Protect from light.
SHELF LIFE
30 months
PACK SIZE
A Bottle of 150 ml
MAL06021261XZ
DATE OF REVISION:
1 October 2018
COMPOSITION
Each 5 ml contains
Iron (III) hydroxide polymaltose complex
equivalent to Elemental Iron
50 mg.
In a syrup base.
PRESERVATIVES :
Methyl Hydroxybenzoate BP
12.5 mg
Propyl Hydroxybenzoate BP
1.25 mg
THERAPEUTIC CLASS:
I 0100
DESCRIPTION OF PRODUCT & PACKAGE
SAFERON SYRUP is haematinic syrup, packed in a printed carton
containing insert, measuring cup &
labeled, sealed 150 ml amber coloured pet bottle.
MECHANISM /MODE OF ACTION
The absorption of ferric iron from iron (III) polymaltose complex is
controlled by a feedback
mechanism. When iron (III) polymaltose complex comes in contact with
the iron binding sites at the
surface of the mucosal cells, a physiological exchange is assumed to
occur, iron (III) polymaltose
complex releases the require
                                
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