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OMEGAVEN

Active substance(s): EGG PHOSPHATIDES PURIFIED / GLYCEROL / HIGHLY REFINED FISH OIL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Omegaven emulsion for infusion

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml emulsion contains:
Highly refined fish oil

10.0 g

containing
eicosapentaenoic acid (EPA) 1.25 - 2.82 g
docosahexaenoic acid (DHA) 1.44 - 3.09 g
dl-α-Tocopherol (as antioxidant)
Glycerol

0.015 - 0.0296 g

2.5 g

Purified egg phosphatide

1.2 g

Total energy:

470 kJ/100 ml = 112 kcal/100 ml

pH value:

7.5 to 8.7

Titration acidity:

< 1 mmol HCl/l

Osmolality:

308-376 mosm/kg

For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Emulsion for infusion
White homogenous emulsion

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Parenteral nutrition supplementation with long chain omega-3-fatty acids,
especially eicosapentaenoic and docosahexaenoic acid, when oral or enteral
nutrition is impossible, insufficient or contraindicated.

4.2

Posology and method of administration
Posology
Daily dose:
1 ml up to max. 2 ml Omegaven/kg body weight
= 0.1 g up to max. 0.2 g fish oil/kg body weight
= 70 ml up to max. 140 ml Omegaven for a patient with a body weight of 70
kg.
Maximum infusion rate:
The infusion rate should not exceed 0.5 ml Omegaven/kg body weight/hour
corresponding to 0.05 g fish oil/kg body weight/hour.
The maximum infusion rate should be strictly adhered to, otherwise a severe
increase in the serum triglyceride concentration can be observed.
Omegaven should be administered simultaneously with other fat emulsions.
On the basis of a recommended total daily lipid intake of 1 - 2 g/kg body
weight, the fish oil portion from Omegaven should constitute 10 - 20% of this
intake.
Method of administration
For infusion via central or peripheral vein.
Containers should be shaken before use.
When Omegaven is to be administered with other infusion solutions (eg amino
acid solutions, cabohydrate solutions) via a common infusion line (by-pass, ytube), the compatibility of the solutions/emulsions used must be ensured.
Duration of administration
The duration of administration should not exceed 4 weeks.

4.3

Contraindications
Severe haemorrhagic disorders.
Certain acute and life-threatening conditions such as:
- collapse and shock

- recent cardiac infarction
- stroke
- embolism
- undefined coma status
Due to lack of experience Omegaven should not be administered in patients
with severe liver or renal insufficiency.
Omegaven should not be used in premature infants, newborns, infants and
children due to limited experience.

General contra-indications for parenteral nutrition:
- hypokalaemia
- hyperhydration
- hypotonic dehydration
- unstable metabolism
- acidoses
Omegaven must not be administered to patients known to be allergic to fish or
egg protein.

4.4

Special warnings and precautions for use
Omegaven should be given with caution to patients with an impaired lipid
metabolism and uncontrolled diabetes mellitus.
The serum triglyceride level should be monitored daily. Checks of blood
glucose profiles, acid base metabolism, serum electrolytes, fluid balance,
blood count and bleeding time in patients treated with anticoagulants must be
carried out regularly. The serum triglyceride concentration should not exceed
3 mmol/l during the infusion of fat emulsions.

4.5

Interaction with other medicinal products and other forms of interaction
The infusion of Omegaven can cause a prolonged bleeding time and an
inhibited platelet aggregation. Therefore, Omegaven should be administered
with caution to patients requiring anticoagulant therapy even with regard to a
possible reduction of anticoagulants.

4.6

Pregnancy and lactation
There is no evidence on the safety of this medicine during pregnancy or
breastfeeding. This medicine should be used during pregnancy and
breastfeeding only if strictly necessary.

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
Undesirable effects observed during the administration of Omegaven:
Investigations:
Rare (≥ 1/10,000, <1/1,000): The infusion of Omegaven can lead to a
prolonged bleeding time and an inhibited platelet aggregation. Clinically
relevant abnormalities have not been observed.
Gastrointestinal Disorders:
Rare (≥ 1/10,000, <1/1,000): fishy taste
Undesirable effects observed during the administration of fat emulsions:
Uncommon
≥ 1/1,000, <1/100

Blood and
lymphatic
system
disorders
Gastrointestinal
disorders
General
disorders and
administration
site conditions
Immune system
disorders
Investigations

Rare
≥ 1/10,000,
<1/1,000

Very rare
< 1/10,000
Thrombocytopenia,
haemolysis,
reticulocytosis

Abdominal pain
nausea, vomiting
Rise in body
temperature,
shivering, chills,
tiredness

Metabolism and Hypertriglyceridaemia
nutrition
disorders
Nervous system Headache

Anaphylactic reaction
Transient increase in
liver function test

disorders
Reproductive
system and
breast
disorders
Skin and
subcutaneous
tissue disorders
Vascular
disorders

Priapism

Rash, urticaria

Circulatory effects
(e.g.
hyper/hypotension)
Trombocytopenia has been reported in association with prolonged treatment
with fat emulsions in infants.
Transient increase in liver function tests after prolonged intravenous nutrition
with or without fat emulsions have also been noted. The reasons are not clear
at present.
Possible signs of metabolic overload must be observed. The cause may be
genetic (individually different metabolisms) and with respect to different
previous illnesses with varying rapidity and following different doses, but has
been observed mainly with the use of cottonseed oil emulsions.
Metabolic overload might give the following symptoms:
hepatomegaly with or without icterus
a change or reduction of some coagulation parameters (e.g. bleeding time,
coagulation time, prothrombin time, platelet count)
splenomegaly
anaemia, leucopenia, thrombocytopenia
bleedings and tendency to bleed
pathological liver function tests
fever
hyperlipidaemia
headache, stomach pains, fatigue
hyperglycemia.
Should these side-effects occur or should the triglyceride level during lipid
infusion rise above 3 mmol/l, the lipid infusion should be stopped or, if
necessary, continued at a reduced dosage.

4.9

Overdose
Overdose leading to fat overload syndrome may occur when the triglyceride
level during lipid infusion rises above 3 mmol/l, acutely, as a result of too
rapid infusion rate, or chronically at recommended rates of infusion in

association with a change in the patient´s clinical condition e.g. renal function
impairment or infection.
Overdosage may lead to side-effects (see 4.8).
In these cases, the lipid infusion should be stopped or, if necessary, continued
at a reduced dosage. The administration of fat also has to be stopped if a
marked increase in blood glucose levels occur during infusion of Omegaven.
A severe overdosage of Omegaven without simultaneous administration of a
carbohydrate solution, may lead to metabolic acidosis.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Emulsion for parenteral nutrition
ATC-Code: BO5BA
The long-chain omega-3 fatty acids in Omegaven are partly incorporated in
plasma and tissue lipids. Docosahexaenoic acid is an important structural
element in membrane phospholipids, while eicosapentaenoic acid is a
precursor in the synthesis of a special class of eicosanoids (prostaglandins,
thromboxanes, leukotrienes, and other lipid mediators). Increased synthesis of
these eicosapentaenoic acid-derived mediator substances may help promote
antiaggregatory, and anti-inflammatory effects, and is associated with
immunomodulatory effects.
The glycerol contained in Omegaven is designed for use in energy production
via glycolysis or is re-esterified together with free fatty acids in the liver to
form triglycerides.
Omegaven also contains egg phospholipids, which are hydrolysed or
incorporated into the cell membranes, where they are essential for the
maintenance of membrane integrity.

5.2

Pharmacokinetic properties
The lipid particles infused with Omegaven are similar in size and elimination
to physiological chylomicrons. In healthy male volunteers, a triglyceride halflife for Omegaven of 54 minutes has been calculated.

5.3

Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional
studies of acute and repeated dose toxicity, safety pharmacology and
genotoxicity. Animal studies to evaluate the reproductive toxicity have not
been conducted
Sensitisation tests
In a test in guinea pigs (Maximisation test) Omegaven showed moderate
dermal sensitisation. A systemic antigenicity test gave no indication of
evidence of anaphylactic potential of Omegaven.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium oleate, sodium hydroxide, water for injections

6.2

Incompatibilities
Incompatibilities may occur through the addition of polyvalent cations, e.g.
calcium, especially when combined with heparin.

6.3

Shelf life
a) Shelf life of the medicinal product as packaged for sale:
18 months
b) Shelf life after dilution or reconstitution according to directions:
Chemical and physical in-use stability of mixtures containing Omegaven has
been demonstrated for 24 hours at 25°C and data is available from the
manufacturer.
From a microbiological point of view, mixtures with fat emulsions or fat
emulsions containing fat-soluble vitamins should be used immediately. If not
used immediately, in-use storage time and conditions prior to use are the
responsibility of the user.
Only if compounding has taken place in controlled and validated aseptic
conditions can storage conditions be based on the manufacturers stability data.
From a microbiological point of view, mixtures compounded in uncontrolled
and unvalidated conditions should normally be used within 24 hours,
including the infusion time (see 6.6 for further information).

c) Shelf life after first opening the container:
Omegaven should be used with sterile transfer equipment immediately after
opening. To be used immediately after breaking the vial seal.

6.4

Special precautions for storage
Do not store above 25 °C. Do not freeze.

6.5

Nature and contents of container
Packs containing 10 glass vials with 50 or 100 ml emulsion
Glass bottles (type II, colourless)
Bromobutyl rubber stoppers.

6.6

Special precautions for disposal and other handling
Containers should be shaken before use.
Use only if the emulsion is homogeneous and the container is undamaged.
Non-phthalate containing equipment should be used for administration
wherever possible.
Any portions of contents as well as mixtures remaining after use should be
discarded.
Omegaven may be aseptically mixed with fat emulsions as well as fat-soluble
vitamins.
When simultaneously administered with other fat emulsions admixed or
diluted before administration (see 6.2 and 6.3.for further information), the fish
oil portion from Omegaven should constitute 10-20% of the total daily lipid
intake.

7

MARKETING AUTHORISATION HOLDER
Fresenius AG
61346 Bad Homburg v.d.H.
Germany

8

MARKETING AUTHORISATION NUMBER(S)
PL 3457/0011

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/06/2009

10

DATE OF REVISION OF THE TEXT
23/04/2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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