FORTRANS FOR ORAL SOLUTION [SIN09234P]
Active ingredients: FORTRANS FOR ORAL SOLUTION
Product Info
FORTRANS FOR ORAL SOLUTION
[SIN09234P]
Product information
Active Ingredient and Strength | MACROGOL 4000 (INN) - 64 G |
Dosage Form | GRANULE, FOR SOLUTION |
Manufacturer and Country | MAYOLY INDUSTRIE - FRANCE |
Registration Number | SIN09234P |
Licence Holder | DKSH SINGAPORE PTE. LTD. |
Forensic Classification | PHARMACY ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A06AX |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Colon lavage in the preparation of patients prior to :
endoscopic or radiological investigations,
colon surgery.
Fortrans is indicated in adults only.
Dosing
4.2 Posology and method of administration
Posology
FOR USE IN ADULTS ONLY
Oral route.
Each sachet must be dissolved in one litre of water.
Stir until complete dissolution of the powder.
The dosage is approximately one litre of the solution for 15 to 20 kg of body weight, which corresponds to an average dosage of 3 to 4 litres.
Method of administration
It is possible to ingest the preparation as a single dose or as divided doses, providing that the total amount of the reconstituted solution is always fully ingested (average of 3 to 4 litres of solution according to the patient’s body weight):
In divided doses: either 2 litres ingested in the evening before the procedure and 1 to 2 litres in the morning of the procedure, the last glass being ingested 3 to 4 hours before the procedure, or 3 litres ingested the night before and 1 litre on the morning of the procedure, the last glass being ingested at the latest 3 to 4 hours before the procedure.
In a single dose: 3 to 4 litres in the evening before the procedure, possibly with a break of one hour after the first 2 litres.
The recommended ingestion rate is 1 to 1.5 litres an hour (i.e. 250 ml every 10 to 15 minutes).
The doctor may adjust the recommended rate according to the patient clinical condition and to potential comorbidities.
Patients with renal impairment
Insufficient data are available for this population (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).Paediatric population.
The safety and efficacy of Fortrans in children aged <18 years has not been established.
Contraindications
4.3 Contraindications
Hypersensitivity to the active substances or to one of the excipients referred to in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Severe heart failure
Serious deteriorations in general health such as dehydration
Advanced carcinoma or any other colonic pathology causing excessive mucosal fragility
Acute phases of intestinal tract inflammation including Crohn's disease and ulcerative colitis;
Gastrointestinal perforation or risk of perforation;
Toxic colitis or toxic megacolon
Patients likely to have or who already have an ileus
Patients likely to have or who already have a gastrointestinal obstruction or stenosis
Gastric emptying disorders (e.g.: gastroparesis, gastric stasis)
