DIPEPTIVEN Concentrate for solution for infusion (2015)
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Περιεχόμενα
1. Name of the medicinal product
Dipeptiven, concentrate for solution for infusion.
2. Qualitative and quantitative composition
<u>1 ml contains:</u> Active substance: N(2)-L-alanyl-L-glutamine Quantity: 200 mg (= 82.0 mg L-alanine, 134.6 mg L-glutamine) theoretical osmolarity: 921 mosmol/l titration acidity: 90–105 mmol NaOH/l ...
3. Pharmaceutical form
Concentrate for solution for infusion. A clear colourless solution.
4.1. Therapeutic indications
Dipeptiven is indicated as part of a clinical nutrition regimen in patients in hypercatabolic and/or hypermetabolic states. It should be given together with parenteral or enteral nutrition or a combination ...
4.2. Posology and method of administration
Solution for infusion after mixture with a compatible infusion solution. Solutions of mixtures with an osmolarity above 800 mosmol/l should be infused by the central venous route. Adults Dipeptiven is ...
4.3. Contraindications
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 ...
4.4. Special warnings and precautions for use
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 ...
4.5. Interaction with other medicinal products and other forms of interaction
No interactions are known to date.
4.6. Pregnancy and lactation
Due to lack of experience, Dipeptiven should not be administered during pregnancy and lactation.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
None known when correctly administered. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring ...
4.9. Overdose
As with other infusion solutions, chills, nausea and vomiting can occur when the infusion rate of Dipeptiven is exceeded. Infusion should be stopped immediately in this case. Experience from a study in ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Amino acids – concentrate for solution for parenteral nutrition <b>ATC code:</b> B05XB02 The dipeptide N(2)-L-alanyl-L-glutamine is endogenously split into the amino acids ...
5.2. Pharmacokinetic properties
N(2)-L-alanyl-L-glutamine is rapidly split into alanine and glutamine after infusion. In man, half-lives of between 2.4 and 3.8 min (in terminal renal insufficiency 4.2 min) and a plasma clearance of between ...
5.3. Preclinical safety data
Acute and sub-chronic toxicity A matrix of dosage finding tests were conducted on rats and dogs over 1 to 7 days. In the rats, infusion of 50 ml/kg b.w. of a 10%, 15%, 20% and 30% solution of N(2)-L-alanyl-L-glutamine ...
6.1. List of excipients
Water for injection
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3. Shelf life
2 years. To be used immediately after the bottle is opened. Dipeptiven is not to be stored after addition of other components.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5. Nature and contents of container
Glass bottles. 1 50 ml, 10 50 ml 1 100 ml, 10 100 ml Type II, colourless glass. Rubber closure. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Dipeptiven is an infusion solution concentrate which is not designed for direct administration. The container and the solution should be inspected visually prior to use. Use only clear, particle-free solution ...
7. Marketing authorization holder
Fresenius AG, 61343 BAD Homburg v.d.H., Germany
8. Marketing authorization number(s)
PA 697/2/1
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 20 May 1996 Date of last renewal: 29 March 2010
10. Date of revision of the text
February 2015
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