Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Parasitic infestations by trematodes, of which:
The dosage varies according to the parasite:
| Schistosoma haematobium | A single dose of 40 mg per kg of body weight |
| Schistosoma mansoni, Schistosoma intercalatum | A single dose of 40 mg or 2 doses of 20 mg per kg of body weight administered every 24 hours. |
| Schistosoma japonicum | A single dose of 60 mg or 2 doses of 30 mg per kg of body weight every 24 hours. |
| Clonorchis sinensis, Opisthorchis viverrini | 3 doses of 25 mg per kg of body weight given in 24 hours |
| Paragonimus westermani | 3 × 25 mg/day per kg of body weight for 2 days |
Safety in children under 1 year of age has not been established. Currently available data is described in section 5.1.
For oral administration.
The tablets should be swallowed whole, with a little liquid, preferably during or after meals.
In order to prevent choking in children under 6 years old, the tablets may be crushed or broken up and mixed with semi-solid food or liquid.
For the once-daily dosing, it is recommended take the tablets in the evening.
If ingestion of tablets several times a day is prescribed, the interval between administration should not be less than 4h and not more than 6h.
The number of tablets needed can be calculated from the following table:
| Body weight (kg) | No. of tablets (=20mg/kg) | Body weight (kg) | No. of tablets (=25mg/kg) | Body weight (kg) | No. of tablets (=30mg/kg) |
|---|---|---|---|---|---|
| 20-25/26 | 3/4 | 22-26 | 1 | 24-28 | 1 1/4 |
| 26/27-33 | 1 | 27-33 | 1 1/4 | 29-33 | 1 1/2 |
| 34-41 | 1 1/4 | 34-38 | 1 1/2 | 34-37 | 1 3/4 |
| 42-48 | 1 1/2 | 39-44 | 1 3/4 | 38-43 | 2 |
| 49-56 | 1 3/4 | 45-50 | 2 | 44-48 | 2 1/4 |
| 57-63 | 2 | 51-56 | 2 1/4 | 49-53 | 2 1/2 |
| 64-70 | 2 1/4 | 57-62 | 2 1/2 | 54-56 | 2 3/4 |
| 71-78 | 2 1/2 | 63-68 | 2 3/4 | 58-63 | 3 |
| 79-86 | 2 3/4 | 69-75 | 3 | 64-67 | 3 1/4 |
There are no available data on human overdose.
5 years.
Store below 25ºC in the original package, in order to protect from light.
Blisters of polyvinylchloride (PVC) and aluminium, in packs with 6 and 20 tablets are available.
Plastic securitainers with 100 and 500 loose tablets, are also available.
Not all pack sizes may be marketed.
None.
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