FLEET PHOSPHO - SODA

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Produkta apraksts Produkta apraksts (SPC)
06-12-2021

Aktīvā sastāvdaļa:

SODIUM PHOSPHATE DIBASIC DIHYDRATE; SODIUM PHOSPHATE MONOBASIC

Pieejams no:

COMBIPHAR - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

SODIUM PHOSPHATE DIBASIC DIHYDRATE; SODIUM PHOSPHATE MONOBASIC

Deva:

2,4 G/5 ML; 0,9 G/5 ML

Zāļu forma:

LARUTAN / CAIRAN

Vienības iepakojumā:

DUS, 1 BOTOL PLASTIK @ 45 ML

Ražojis:

COMBIPHAR - Indonesia

Autorizācija datums:

2019-02-28

Produkta apraksts

                                COMPOSITION
Each dose (45 mL) contains:
Sodium dihydrogen phosphate dihydrate 24.4 g;
Disodium phosphate dodecahydrate 10.8 g
Also includes: Ethanol, sodium benzoate. Sodium content 5.0 g per each
45 mL dose.
MODE OF ACTION
Phospho-soda produces bowel actions which cleanse the bowel.
Phospho-soda acts by osmotic process to
increase fluid retention in the lumen of the small intestine. Fluid
accumulation in the ileum produces distension
and, in turn, promotes peristalsis and bowel evacuation. It usually
work within 30 minutes, although it may
take as long as six hours.
INDICATIONS
Phospho-soda is used as part of a bowel cleansing procedure before
X-ray of the bowel, colonoscopy
(looking into the bowel with an instrument) or before a bowel
operation.
CONTRAINDICATIONS
Phospho-soda is contraindicated:
• In children under 15 years (particularly at risk of dehidration).
• Patient with faecal impaction, paralytic ileus, bowel obstruction,
hypomotility, Hirschsprung’s disease
(congenital megacolon), imperforate anus, congestive heart failure,
ascites conditions, renal insufficiency
and impaired renal function and pre-existing potential
fluid/electrolyte disturbance.
• Patients at risk of dehydration due to altered senses and/or poor
fluid intake.
• Patients with known or suspected gastrointestinal obstruction or
lack of motility.
• Patients with known active inflammatory bowel disease.
• Patients when nausea, vomiting or abdominal pain are present.
• Patients with known hypersensitivity to active ingredients or any
of the excipient.
WARNING
Serious electrolyte disturbances (hypernatremia, hypokalemia,
hyperphosphatemia, hypocalcemia)
dehydration, metabolic acidosis, renal failure, tetany and death have
been attributed to physicians prescribing
more than 45 ml dose (usually a minimum of 90 ml during a 24-hour
period) as a bowel preparation for
colonoscopy, surgery or barium enema and/or prescribing it for people
at medical risk.
PRECAUTIONS
Phospho-soda should be used with extreme caution in the elderly, i
                                
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