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OMEGAVEN

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

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M0xxxxxx/xx EXP
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.
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.

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irregularities of the blood - anaemia, low white bloodcell count
bleeding and a tendency to bleed
altered liver function tests
fever
high lipid levels in the blood (hyperlipidaemia)
headache, stomach pains, fatigue
a high sugar level in the blood (hyperglycemia)

Should any of these side effects occur your infusion may be stopped
or if necessary , continued at a reduced dose.
Overdose leading to fat overload syndrome may occur:
This might happen when your body has problems using fat, because
of having too much Omegaven. It may also happen because of a
sudden change in your condition (such as kidney problems or
infection). Possible signs are fever, problems in various organs of
the body and coma. All these will usually disappear when you stop
having the infusion.
A severe overdosage of Omegaven without administration of a
carbohydrate solution at the same time, may lead to metabolic acidosis.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

5.

HOW TO STORE OMEGAVEN

FURTHER INFORMATION

Omegaven

What Omegaven contains
The active substances are

Emulsion for infusion

100 ml emulsion contains:
Highly refined fish oil
Containing:
eicosapentaenoic acid (EPA)
docosahexaenoic acid (DHA)
dl-α-Tocopherol (as an antioxidant)

10.0 g
1.25 - 2.82 g
1.44 - 3.09 g
0.015 - 0.0296 g

Glycerol
Purified egg phosphatide

2.5 g
1.2 g

The other ingredients are
sodium oleate, sodium hydroxide, water for injections.
Total energy:
pH value:
Titration acidity:
Osmolality:

470 kJ/100 ml = 112 kcal/100 ml
7.5 to 8.7
< 1 mmol HCl/l
308-376 mosm/kg

What Omegaven looks like and contents of the pack
Emulsion for infusion, white homogenous emulsion
Glass vials (type II, colourless) and bromobutyl rubber stoppers.
Pack sizes: 1 x 50 ml, 10 x 50 ml, 1 x 100 ml, 10 x 100 ml.

Keep out of the reach and sight of children.

Not all pack sizes may be marketed.

Do not use Omegaven after the expiry date which is stated on the
label after ”EXP”.The expiry date refers to the last day of that month.

Marketing Authorisation Holder and Manufacturer

Do not store above 25ºC. Do not freeze.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
V001

6.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Marketing Authorisation
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H. Germany
Manufacturer
Fresenius Kabi Austria GmbH
8055 Graz, Austria
This leaflet was last approved in: July/2012

Read all of this leaflet carefully before you start using this medicine.
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or nurse.
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This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
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If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Omegaven is and what it is used for
2. Before you receive Omegaven
3. How you are given Omegaven
4. Possible side effects
5. How Omegaven is stored
6. Further information

1.

WHAT OMEGAVEN IS AND WHAT IT IS
USED FOR

Omegaven provides energy and omega-3 fatty acids derived from
fish oil into your bloodstream when oral nutrition is impossible,
insufficient or not recommended.

2.

What you need to know before
you use Omegaven

Omegaven will not be used
• if you are allergic (hypersensitive) to fish or egg protein or any of
the ingredients of Omegaven. For symptoms of an allergic reaction
please refer to section 4.
• if you have severe bleeding disorders
• if you have collapsed or are in shock
• if you have recently had a severe heart attack










if you recently had a severe stroke,
if you been told that you have a severe embolism (blockage of the artery)
if you suffer from low potassium level (hypokalaemia),
if you have too much fluid in your body (hyperhydration)
if you are dehydrated with low levels of sodium
if your metabolism is unstable
if you have acidosis (where the acid levels of your body fluids
and tissues become too high)
if you suffer from serious liver or kidney insufficiency

Due to limited experience, Omegaven should not be given to
premature infants, newborns, infants and children up to 11 years.
This medicine will not be given to you if you are in an in an uncertain
state of unconsciousness.
Take special care with Omegaven.
Inform your doctor if you suffer from:
• diabetes (type 1 and 2 diabetes)
• a condition where your body has problems using fat properly
Inform your doctor if you are taking medicines used in anticoagulation
therapy to thin your blood. If you are taking blood thinning medicines
(anticoagulants) your doctor may want to do regular blood tests to
make sure that your therapy is well controlled.
Your serum triglyceride level may be monitored daily and its concentration
should not exceed 3 mmol/l during the infusion of fat emulsions.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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.

3.

HOW TO USE OMEGAVEN

You will receive your medicine by infusion.

Your doctor will decide on the correct dose and infusion rate for you.
It will depend on your body weight in kilograms and your body’s
ability to use fat. The infusion will be given to you in the hospital by a
healthcare professional.
The duration of administration should not exceed 4 weeks.
Dose
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.
If you receive too much Omegaven
It is very unlikely that you will receive more infusion than you should as
your doctor or nurse will monitor you during the treatment. For the effects
of an overdose see section 4 “Possible side effects”. If you believe that
you have received too much Omegaven inform your doctor or nurse
immediately. If this happens the infusion will be stopped immediately. It
may be possible to continue with a reduced dosage. These symptoms
will usually disappear on reducing the rate or stopping the infusion.
If you have any further questions on the use of this product, ask your doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Omegaven can cause side effects, although not
everybody gets them.

Undesirable side effects observed during the administration of
Omegaven
Rare
• Prolonged bleeding time and and impaired
(affects 1 to 10
blood clotting
users in 10,000)
• A fishlike taste in your mouth
Undesirable side effects observed during the administration of
fat emulsions
Uncommon
• Abdominal pain, nausea (feeling sick),
(affects 1 to 10
vomiting
users in 1,000)
• Rise in body temperature, shivering, chills,
tiredness
• Hypertriglyceridaemia (excess fats in the
blood)
• Headache
Very rare
• Anaphylactic reaction (severe allergic-like
(affects less than 1
reaction characterized by a considerable
user in 10,000)
increase of body temperature and difficulties
in breathing)
• Rash, urticaria (nettle rash i.e. a bumpy and
itchy like rash appears on your body)
• Circulatory effects - e.g. hypertension or
hypotension (high or low blood pressure)
• Abnormal blood values (thrombocytopenia,
haemolysis, reticulocytosis)
• Transient (temporary) increase in liver
function test
• Priapism (persistent, usually painful erection)

Possible signs of metabolic overload must be observed. The cause may
be genetic (Individual differences in metabolism) or from previous illnesses
However, this has been observed mainly with the use of cottonseed oil
emulsions.
Metabolic overload might give the following symptoms:
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enlargement of the liver (hepatomegaly) with or without jaundice
(yellowing of the skin)
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a change or reduction of some coagulation parameters (e.g.
bleeding time, coagulation time, prothrombin time, platelet count)
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enlargement of the spleen (splenomegaly)

-----------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
The usual daily dose is:
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.
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 together 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. 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 littered.
Incompatibilities
When Omegaven is to be administered with other infusion solutions (e.g.
amino acid solutions, carbohydrate solutions) via a common infusion line
(by-pass, y-tube), the compatibility (tolerance) of the solutions/emulsions
used must be ensured.
Incompatibilities may occur through the addition of polyvalent cations, e.g.
calcium, especially when combined with heparin (anticoagulant).
Duration of administration
The duration of administration should not exceed 4 weeks.
PHARMACOLOGICAL PROPERTIES
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

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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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