Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
GRANUPAS is indicated for use as part of an appropriate combination regimen for multi-drug resistant tuberculosis in adults and paediatric patients from 28 days of age and older when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4 g (one sachet) three times per day. The recommended schedule is 4 g every 8 hours. GRANUPAS can be taken with food. Maximum daily dose is 12 g. Usual duration of treatment is 24 months.
Desensitization can be accomplished by starting with 10 mg para-aminosalicylic acid (PAS) given as a single dose. The dosage is doubled every 2 days until reaching a total of 1 gram after which the dosage is divided to follow the regular schedule of administration. If a mild temperature rise or skin reaction develops, the increment is to be dropped back one level or the progression held for one cycle. Reactions are rare after a total dosage of 1.5 g.
The optimal dose regimen in children is uncertain. Limited pharmacokinetic data suggest no substantial difference between adults and children.
For infants, children and adolescents the dosage will be adapted to the patient’s weight at 150 mg/kg per day, divided in two intakes. A dosing spoon is provided to measure small doses below 4 g for young children.
The safety and efficacy of para-aminosalicylic acid in neonates have not been established. No data are available.
Oral use.
The contents of the sachet should be added to a glass of orange or tomato juice. They will not dissolve, but swirling the juice in the glass will help re-suspend the granules if they sink. It should be drunk at once ensuring that the granules are not left in the glass. Any granules left-over at the bottom of the glass should be swallowed immediately by adding a small quantity of liquid. Smaller doses in children should be measured using the dosing spoon and given by sprinkling on apple sauce or yogurt.
The medicinal product should be swallowed immediately after mixing with orange juice, tomato juice, apple sauce and yogurt whilst the granules are intact.
The granules should not be crushed or chewed, as this impairs the gastro-resistant coating
There is no experience with overdose in humans. In the event of overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse reactions and that appropriate symptomatic treatment is instituted immediately.
Shelf life: 2 years.
The sachets can be stored below 25°C up to 24 hours after first opening.
Do not store above 25°C.
For storage conditions after first opening of the medicinal product, see section 6.3.
Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.
Pack size of 30 sachets. A calibrated measuring spoon is provided.
The sachet should not be used if it is swollen or if the granules have lost their light brown colour, and are turning dark brown or purple.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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