ClinOleic 20% infusion 250ml bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Olive oil; Soya oil

Available from:

Baxter Healthcare Ltd

INN (International Name):

Olive oil; Soya oil

Dosage:

160gram/1litre ; 40gram/1litre

Pharmaceutical form:

Infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5413760207902

Summary of Product characteristics

OBJECT 1
CLINOLEIC 20%
Summary of Product Characteristics Updated 01-Apr-2015 | Baxter
Healthcare Ltd
1. Name of the medicinal product
ClinOleic 20%
2. Qualitative and quantitative composition
Composition per 100 ml
Refined olive oil and refined soybean oil*
20.00g
corresponding to a content of essential fatty acids
4.00g
*Mixture of refined olive oil (approximately 80%) and refined soybean
oil (approximately 20%)
Energy content
2000 kcal/l (8.36 MJ/l)
Lipid content (olive and soybean oil)
200 g/l
Osmolarity
270 mOsm/l
pH
6-8
Density
0.986
ClinOleic contains 47 milligrams or 1.5 mmol of phosphorus per 100 ml
3. Pharmaceutical form
Emulsion for infusion.
ClinOleic 20% contains 200 g/l of lipids corresponding to 200 mg/ml.
4. Clinical particulars
4.1 Therapeutic indications
ClinOleic 20% is indicated as a source of calories and essential fatty
acids for patients requiring
parenteral nutrition.
4.2 Posology and method of administration
The emulsion is for administration by intravenous infusion as part of
a parenteral nutrition regimen.
Posology
The posology depends on energy expenditure, the patient's clinical
status, body weight, and ability to
metabolize ClinOleic 20%, as well as additional energy given
orally/enterally. Therefore, the dosage
should be individualized and the bag size chosen accordingly.
The maximum daily dose of ClinOleic 20% should be based on individual
total nutritional requirements
and patient tolerance.
_Adult patients_
Up to 60% of the energy requirements of the patient can be provided by
ClinOleic 20%.
The infusion should be started at a rate of 0.5ml per minute for the
first 15-30 minutes. The rate can then
be increased to allow 500ml of ClinOleic 20% to be administered on the
first day. On subsequent days the
dose may be increased to a maximum of 2.5g lipids/kg of body weight
with a maximum infusion rate of
0.25g lipids/kg/hour.
_Paediatric patients_
Up to 60% of the energy requirements of the patient can be provided by
ClinOleic 20%.
The infusion should be started at a rate of 0.05ml per