Professional Documents
Culture Documents
Clinoleic 20% PN PDF
Clinoleic 20% PN PDF
Per 100 mL
*Mixture of refined olive oil (approximately 80 %) and refined soya been oil (approximately 20%)
Pharmaceutical form
Emulsion for infusion
Milk-like homogenous liquid
Clinical Particulars
Therapeutic indications
Indicated as a source of lipids for patients requiring parenteral nutrition, when oral or enteral
nutrition is impossible, insufficient or contraindicated.
Route of administration
Intravenous infusion
· When administered as part of complete nutrition admixture (with glucose and amino acids) the
central and peripheral venous rate should be chosen depending on osmolarity of the final
mixture.
· In rare cases, when infused alone as a complementary support to oral or enteral nutrition,
CLINOLEIC 20% can be administered via peripheral vein.
Dosage
In adults:
The dosage is 1 g/kg/day to maximum of 2 g lipids/kg/day. The initial infusion rate must be slow
and not exceed 0.1 g lipids or 0.5 ml (10 drops) per minute for 10 minutes then gradually
increased untill reaching the required rate after half an hour.
Never exceeds 0.15 g lipids/kg/hour (0.75 ml/kg/hour).
Adults per kg of body weight Adults per 70 kg
Usual lipid dosage 1 to 2 g/kg/day 70 to 140 g/day
Infused volume of
5 to 10 ml/kg/day 350 to 700 ml/day
CLINOLEIC 20%
In Children
CLINOLEIC 20% should be administered as a continous 24h/day infusion. It is recommended
not to exceed a daily dose of 3g-lipids/kg b.w. (body weight) and an infusion rate of 0.15 g
lipids/kg b.w/h.
Daily dose should be increased gradualy during the first week of administration.
Contraindications
· Hypersensitivity to the active substance or to any of the excipients (e.g. egg or soybean protein)
· Severe dyslipidemia and not corrected metabolism disorder including lactic acidosis and
uncompensated diabetes.
· Severe sepsis
· Severe liver disease
· Blood coagulation disorders, thrombophlebitis.
· Myocardial infarction
Undesirable Effects
Allegic reactions (hypersensitivity to egg and soybean protein) may occur rarely. At the beginning
of the infusion, any of the following abnormal signs (sweating, shivering, cephalgia, dyspnea)
should be caused for immediate discontinuation of the infusion.
During long-term parenteral nutrition, the following adverse reactions have been observed:
· Increase of alkaline phosphatases, transaminases, bilirubin,
· Rarely: hepatomegaly and icterus,
· Moderate thrombocytopenia
Overdose
In case of overdosing (an abnormal triglyceride rise under infusion of fat) causing special
reactions (general symptoms such as fever or evocating an hemodynamic instability, emesis,
a l g i a , liver function abnormalities, hepato or splenomegaly, hemostasis disorders,
hyperlipidemia, hypersensitivity) fat infusion should be stopped or if necessary, continued at
reduce dosage.
Pharmacological Properties
Pharmacodynamic Properties
ATC code: B05BA02
The combination of olive and soybean oils allows a content of fatty acids in an approximate ratio
of:
· Saturated faty acids: 15% (SFA)
· Mono-unsaturated fatty acids: 65% (MUFA)
· Essential Poly-unsaturated fatty acids: 20% (EFUPA)
The moderate level of essential fatty acids (EFA) probably facilitates their utilization, enables a
correct status of EFA upper derivatives and corrects EFA deficiency.
In comparison with soybean oils:
· In preterm infants above 28 weeks of gestational age, treated for 7 days, the higher content in a
tocopherol related to the presence of olive oil, results in an improved vitamin E status.
· In children (8 per treatment group) under long-term parenteral nutrition, for 2 months, a better
vitamin E/EPUFA ratio results in reduced lipid peroxydation.
These properties have been verified for doses ranging from 1 to 3 g/kg/day. The high-energy
content of the emulsion enables the administration of a large quantity of calories in a small
volume.
Pharmacokinetics Properties
Clearance rate of lipid emulsions in dependent of particle size: Small lipid droplet size tends to
delay the clearance, while it improves lipolysis by lipoprotein lipase.
CLINOLEIC 20%, which has droplet size close to that of chylomicrons, has a similar elimination
rate.
Pharmaceutical Particulars
List of excipients
· Egg phosphatides
· Glycerol
· Sodium oleate
· Sodium hydroxide
· Water for injections
Incompatibilities
Complete information about incompatibilities is not available.
Never add medication or electrolytes directly to the lipid emulson. If it is necessary to introduce
additives, verify the compatibility and mix thoroughly before administration to the patient.
Shelf Life
18 months in plastic bag in its overwrap.
In bag
100 ml in plastic bag
250 ml in plastic bag
500 ml in plastic bag
Presentation
100 ml in plastic bag Reg. No. DKI0910700249A1
250 ml in plastic bag Reg. No. DKI0910700249A1
500 ml in plastic bag Reg. No. DKI0910700249A1
Manufacture by:
Bexter SA
Boulevard Rene Branquart 80,
7860 Lessines, Belgium