Seven Seas Iron Plus Syrup

Country: Malaysia

Language: English

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

Active ingredient:

NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; D-BIOTIN; SODIUM FEREDETATE

Available from:

PROCTER & GAMBLE (MALAYSIA ) SDN.BHD.

INN (International Name):

NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; D-BIOTIN; SODIUM FEREDETATE

Units in package:

100 kg

Manufactured by:

PT MERCK INDONESIA

Summary of Product characteristics

SEVEN SEAS IRON PLUS SYRUP
Iron used to prevent iron anemia and prevent anemia due to iron
deficiency. Iron helps in formation of red blood cell and at same time
to maintain good
health.
APPEARANCE: Brownish - yellow, clear solution, having an aromatic odor
COMPOSITION:
Each 1 mL contains;
Sodium Feredetate (equivalent to Iron 3 mg)
22.6 mg
Thiamine Hydrochloride (providing 0.178 mg)
0.2 mg
Pyridoxine Hydrochloride (providing 0.246 mg)
0.3 mg
Nicotinamide
3.0 mg
Riboflavin
0.2 mg
Biotin
0.06 mg
Methyl-4-hydroxy benzoate (0.39 mg), Propyl-4-Hydroxybenzoate (0.39mg)
as preservative:
DOSAGE RECOMMENDATION:
Children (1 - 4 years): 2.5mL per day after meals.
Children (above 4 years) and adult: 5mL per day after meals.
Unless otherwise prescribed by physician or pharmacist.
CONTRAINDICATION:
INDICATION:
1) Anemia other than Iron-deficiency anemia
As health supplement.
2) Hemochromatosis
3) Hemosoderosisi
4) Hypersensitivity to iron products
SIDE EFFECTS:
Adverse effects which might happen are: nausea, gastric irritation,
constipation, diarrhea and colic. These symptoms usually are mild and
can be
minimized by reducing
the dosage or administering the preparation after meals, though this
might decrease the absorption rate.
OVERDOSE & TREATMENT:
REFERENCE: electronic Medicines Compendium (eMC)
Initial symptoms of iron overdosage include nausea, vomiting,
diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and
circulatory
collapse. Hyperglycaemia and metabolic acidosis may occur.
TREATMENT OF OVERDOSAGE:
1. Administer an emetic.
2. Emesis should be followed by gastric lavage with desferrioxamine
solution (2g/l). Desferrioxamine 5g in 50ml to 100ml water should be
introduced into the stomach following gastric emptying.
3. Keep the patient under constant surveillance to detect possible
aspiration of vomitus. Maintain suction apparatus and standby
emergency
oxygen in case of need.
4. In adults, a drink of mannitol or sorbitol should be given to
induce small bowel emptying. Inducing diarrhoea in children may be