- Children: No data are available on the use of
LIPOMED ® 20% MCT/LCT
Soya Oil,
Medium-chain Triglycerides,
Emulsion for Intravenous Infusion
COMPOSITION
Each 1000 mL contains:
Soya Oil ....................................................................... 100 g
Medium-chain Triglycerides ..................................... 100 g
- Tocopherol, Sodium Oleate,
Egg Lecithin, Glycerol, a
Sodium Hydroxide, Water for Injection.
Osmolarity ± 380 mOsm/L
PHARMACOLOGY
The mode of action is just the same as the one given
orally. Medium-chain Triglycerides as a source of
calories. Long-chain Triglycerides supply essential fatty
acid which is needed by the body.
INDICATIONS
LIPOMED ® 20% MCT/LCT is indicated as a source of
calories and essential fatty acids for patients requiring
parenteral nutrition.
CONTRA-INDICATIONS
- The administration of LIPOMED ® 20% MCT/LCT is
contra-indicated in patients demonstrating disturb-
ances in normal fat metabolism such as pathologic
hyperlipemia, lipoid nephrosis, severe liver damage
or acute pancreatitis if accompanied by hyper-
lipemia. It is further contra-indicated in patients with
ketoacidosis or hypoxia, in thromboembolism and in
acute shock states.
- Since egg yolk phospholipids are present do not
administer to patients with severe egg allergies.
ADVERSE REACTIONS
Adverse reactions directly related to fat emulsions in
general are of two types:
- Immediate (acute) reactions: Dyspnea, cyanosis, al-
lergic reactions, hyperlipemia, hypercoagulability,
nausea, vomiting, headache, flushing, hyperthermia,
sweating, chills, sleepiness, chest and back pain.
- Delayed reactions: Hepatomegaly, jaundice due to
central lobular cholestasis, splenomegaly, thrombo-
cytopenia, leucopenia, transient increases in liver
function tests, and overloading syndrome. The de-
position of a brown pigmentation in the reticuloendo-
thelial system, the so-called “intravenous fat pig-
ment”, has been reported. The cause and the sig-
nificance of this phenomenon are unknown.
PRECAUTIONS
- Caution should be exercised in administering intra-
venous fat emulsions in patients with metabolic
acidosis, liver damage, pulmonary disease, sepsis,
diseases of the reticuloendothelial system, renal
insufficiency, anemia or blood coagulation disorders,
or when there is danger of fat embolism.
- The too rapid infusion of fat emulsions can cause fluid
and/or fat overloading resulting in dilution of serum
electrolyte concentrations, overhydration, congested
states, pulmonary edema, impaired pulmonary
diffusion capacity, fat embolism. A too rapid infusion
of LIPOMED ® 20% MCT/LCT can also cause hyper-
ketonaemia and/or metabolic acidosis, especially
when carbohydrates are not administered simulta-
neously.
- When LIPOMED ® 20% MCT/LCT is administered, the
patient's capacity to eliminate the infused fat from
the circulation must be monitored. The lipemia must
clear between daily infusions.
- Especially where fat emulsions are administered for
extended periods of time and in neonates, the pa-
tient's haemogram, blood coagulation, liver function
and platelet count should be closely monitored.
- Administration of LIPOMED ® 20% MCT/LCT should be
accompanied by simultaneous carbohydrate infu-
sions making up to 40% (at least) of the total calorie
intake.
LIPOMED ® 20% MCT/LCT in children.
- The safety of LIPOMED ® 20% MCT/LCT during preg-
nancy and lactation has not been assessed, but it
use during these periods is not considered to consti-
tute a hazard. Nevertheless, medicines should not
be used in pregnancy especially during the first
trimester, unless the expected benefit is thought to
outweight any possible risk to the fetus.
DOSAGE
Adult Patients
LIPOMED ® 20% MCT/LCT can provide up to 60% of
the daily non-protein calories at an average dose of
1 - 2 g/kg of body weight per day.
The infusion rate (for 70 kg patient) during the first
15 minutes should not exceed 0.25 - 0.5 mL/kg body
weight/hr. If no adverse effects are observed during
this initial infusion, the rate can be increased to 1 mL/kg
body weight/hr.
Not more than 250 mL of LIPOMED ® 20% MCT/LCT
should be infused into adults on the first day of therapy.
If the patient shows no untoward reactions, the dose
can be increased on the following day.
Maximum therapy should not be more than 10 days.
Fat emulsions should be allowed to warm to room
temperature before infusion.
ON MEDICAL PRESCRIPTION ONLY
SHAKE WELL BEFORE USE
DO NOT ADMINISTER IF EMULSION IS NOT HOMOGENOUS
AFTER SHAKING OR IF BOTTLE IS DAMAGED
Administration
LIPOMED ® 20% MCT/LCT should be administered
as part of a total parenteral nutrition regimen via
a peripheral vein or a central venous catheter.
LIPOMED ® 20% MCT/LCT can be infused into the
same central or peripheral vein as the carbohy-
drate and amino acid solutions by means of a short
Y-connector near the infusion site. This allows for mixing
of the solutions immediately before entering the vein.
Flow rates of each solution should be controlled
separately by infusion pumps, if these are used. As a
general rule fat emulsions should not be mixed with
electrolytes, drugs or any other additives in the infusion
bottle. LIPOMED ® 20% MCT/LCT may be used with
nutrient mixing bag systems only if the resulting mixtures
are compatible and stable.
Filters should not be used for administration of fat
emulsions.
OVERDOSAGE
In the event of fat overload during therapy, stop the
infusion of LIPOMED ® 20% MCT/LCT , until visual in-
spection of the plasma, determination of triglycerides
concentrations, or measurement of plasma light-
scattering activity by nephelometry indicate the lipid
has cleared. Re-evaluate the patient and institute
appropriate corrective measures.
PRESENTATION
Glass bottle with contents of 100 mL
Glass bottle with contents of 250 mL
Glass bottle with contents of 500 mL
Reg. No.: DKL1222249949A1
STORAGE
Store at temperature below 30°C. Do not freeze.
If accidentally frozen, discard bottle. Unused contents
must be discarded and should not be stored for later
use. Do not use bottles showing evidence of phase
separation.
Manufactured by: PT SANBE FARMA
Bandung - Indonesia
* BI 058 - 2