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Biochetasi suppositories children and adults minsan 015784022

  • ALFASIGMA SpA
  • 015784022

Indicated in case of vomiting and nausea.

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BIOCHETASE * 6SUPP

Therapeutic indications

Toxic states, with special reference to those involving a state of acidosis or ketosis, namely: pregnancy vomiting, diabetic acidosis and coma, liver failure with impaired digestion of fats, intoxication from burns.

Dosage and method of use

1-2 suppositories a day. Special populations Patients with hepatic insufficiency : Studies with biochetase have not been conducted in patients with hepatic insufficiency. Patients with renal insufficiency : Studies with bioketase have not been conducted in patients with renal insufficiency.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Side effects

The following are the undesirable effects organized according to the MedDRA System and Organ classification. Adverse reactions are derived from literature data and post marketing reports. As it was not possible to calculate the frequency, they are reported as not known (the frequency cannot be estimated from the available data). Immune system disorders Urticaria. Gastrointestinal disorders Nausea. Skin and subcutaneous tissue disorders Rash, Edema of the lips. Renal and urinary disorders Chromaturia. Some cases of anaphylactic shock have been reported in patients treated with parenteral thiamine. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Special warnings

Medicinal products containing vitamin B 1 or its derivatives can, especially if administered parenterally, induce the onset of atopic manifestations in patients with hypersensitivity.

Pregnancy and breastfeeding

Biochetasi can be administered both in case of pregnancy and during breastfeeding with breast milk.

Expiration and retention

Do not store above 25 ° C.

Interactions with other drugs

Absorption of riboflavin is affected by propantheline bromide. Particular caution is required in Parkinson's patients treated with levodopa because vitamin B6 (pyridoxine) can antagonize the therapeutic effects. The use of citrate preparations may increase the gastrointestinal absorption of aluminum (e.g. aluminum-containing antacids).

Overdose

Prolonged use of pyridoxine in high dosages can cause neuropathies. High doses of potassium-containing products can cause hyperkalaemia and alkalosis, particularly in patients with renal insufficiency. High doses of citrate preparations can have a saline laxative effect when administered orally.

Active principles

Suppositories Active ingredients: free ester thiamine diphosphate 150 mg monosodium riboflavin-5'-monophosphate 50 mg (equal to 47.7 mg of free acid) vitamin B 6 mg 30 sodium citrate 250 mg potassium citrate 10 mg For the list full of excipients, see section 6.1.

Excipients

Solid semisynthetic glycerides.

ALFASIGMA SpA
015784022