Source: Health Products Regulatory Authority (IE) Revision Year: 2015 Publisher: Fresenius AG, 61343 BAD Homburg v.d.H., Germany
Dipeptiven should not be administered to patients with severe renal insufficiency (creatinine clearance <25 ml/minute), severe hepatic insufficiency, severe metabolic acidosis or known hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
For a safe administration the maximum dose of Dipeptiven should not exceed 2.5 ml (corresponding to 0.5 g N(2)-Lalanyl-L-glutamine) per kg body weight per day (see section 4.2, 4.9 and 5.1).
Dipeptiven should only be used as part of clinical nutrition, and its dosage is limited by the amount of protein/amino acids provided by nutrition (see section 4.2). Whenever the clinical condition does not allow nutrition (e.g., circulatory shock, hypoxia, severe metabolic acidosis) Dipeptiven should not be administered.
Oral/enteral intake of glutamine-supplemented formulas in combination with parenteral nutrition should be taken into consideration for calculation of the prescribed dose of Dipeptiven.
It is advisable to regularly monitor liver function parameters in patients with compensated hepatic insufficiency.
As there is currently insufficient data on administration of Dipeptiven to pregnant women, nursing mothers and children, administration of the preparation in these patient groups is not recommended.
Serum electrolytes, serum osmolarity, water balance, acid-base status as well as liver function tests (alkaline phosphatase, ALT, AST) and possible symptoms of hyperammonaemia should be controlled.
The enzymes alkaline phosphatase, GPT, GOT, bilirubin level and the acid-base status should be monitored.
The choice of a peripheral or central vein depends on the final osmolarity of the mixture. The generally accepted limit for peripheral infusion is about 800 mosmol/l but it varies considerably with the age and general condition of the patient and the characteristics of the peripheral veins.
Experience with the use of Dipeptiven for longer periods than nine days is limited.
No interactions are known to date.
Due to lack of experience, Dipeptiven should not be administered during pregnancy and lactation.
Not applicable.
None known when correctly administered.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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