Tablet: Treatment of Ulcerative colitis: Active disease: Adults: Individual dosage, up to 4 g daily in divided doses.
Children (≥6 years of age): Individual dosage, starting with 30-50 mg/kg/day in divided doses.
Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: Adults: Individual dosage. Recommended dosage, 2 g once daily. Can also be taken in divided doses.
Children (≥6 years of age): Individual dosage, starting with 15-30 mg/kg/day in divided doses.
The total dose should not exceed 2 g/day (recommended adult dose).
Treatment of Crohn's disease: Active disease: Adults: Individual dosage, up to 4 g daily in divided doses.
Children (≥6 years of age): Individual dosage, starting with 30-50 mg/kg/day in divided doses.
Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: Adults: Individual dosage, up to 4 g daily in divided doses.
Children (≥6 years of age): Individual dosage, starting with 15-30 mg/kg/day in divided doses.
The total dose should not exceed 4 g/day (recommended adult dose).
There is only limited documentation for an effect in children (age 6-18 years). It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Granules: Posology: Ulcerative colitis: Adults: Active disease: Individual dosage, up to 4 g mesalazine once daily or divided into 2-4 doses.
Maintenance treatment: Individual dosage. Recommended dosage, 2 g mesalazine once daily.
Pediatric population: The safety and efficacy in children below 6 years of age have not been established.
There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older: Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses.
Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Crohn's disease: Treatment of active disease: Children 6 years of age and older: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: Children 6 years of age and older: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Suppository: 1 suppository 1-2 times daily.
Paediatric population: There is little experience and only limited documentation for an effect in children.
Rectal Suspension: Adults: 1 rectal suspension at bedtime.
Paediatric population: There is little experience and only limited documentation for an effect in children.
Method of Administration: Tablet: Mesalazine (PENTASA) tablets must not be chewed. To facilitate swallowing the tablets may be dispersed in 50 ml of cold water. Stir and drink immediately.
Granules: Oral use.
The granules must not be chewed.
The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately.
Suppository: A visit to the toilet is recommended before administration of suppositories.
Rectal Suspension: A visit to the toilet is recommended before administration of enemas. Shake the enema container well before use. The enema is protected by an aluminium foil bag and should be used immediately after opening of the bag.
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