infusion solution, emulsion
What Omegaven is and what it is used for
Omega gives energy and omega-3 fatty acids extracted from fish oil directly to your blood when you can not eat food by mouth, in insufficient amount or if you are not allowed to eat.
What you need to know before you are given Omegaven
You should not be given the Omega
- if you are allergic to any of the active substances or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic (hypersensitive) to fish or egg protein
- if you have severe bleeding disorders
- if you have collapsed and are in a state of shock
- if you have recently had a severe heart attack
- if you have recently had a severe stroke , (cerebral haemorrhage or clot in the brain)
- if you have been told that you have a severe embolism (stop an artery )
- if you have too low a level of potassium in your blood ( hypokalaemia )
- if you have too much fluid in your body (hyperhydration)
- if you are dehydrated and have too low a level of sodium in your blood ( hypotonic dehydration )
- if your metabolism is unstable
- if you suffer from acidosis (too much acid in your body fluid and body tissue)
- if you suffer from a severe impairment of liver or kidney function
This medicine will not be given to you if you are unconscious for no known reason.
Warnings and cautions
Talk to your doctor before using Omegaven if you suffer from:
- diabetes (type 1 or 2 diabetes )
- suffers from a condition that makes it difficult for you to assimilate fat in a normal way
If you are taking blood-thinning medicines ( anticoagulants ), your doctor may need to prescribe regular blood tests to check that your blood-thinning treatment is working well.
Your serum triglyceride levels may need to be monitored daily and your concentration should not exceed 3 mmol/liter while you are being infused with fat emulsions.
Children
Due to limited experience, Omegaven should not be given to premature babies, newborns, infants, and children up to 11 years of age.
Other medicines and Omegaven
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you use:
- medicines that counteract blood clots, by thinning your blood (eg Heparin )
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is no information showing whether it is safe to use this medicine during pregnancy and breastfeeding.
This medicine should only be given during pregnancy and breastfeeding if necessary.
How the Omega is given
You will receive your medicine as an infusion.
Your doctor will decide which dose and infusion rate is right for you. It depends on your body weight in kg and your ability to assimilate fat. Infusion one will be given to you by medical staff at the hospital.
The treatment should not exceed four weeks.
Dosage
Dosage per day:
1 ml to a maximum of 2 ml Omegaven / kg body weight (= 0.1 g to a maximum of 0.2 g fish oil/kg body weight).
For a 70 kg patient, this equates to 70 ml to a maximum of 140 ml of Omegaven.
Maximum infusion rate: The infusion rate
should not exceed 0.5 ml Omegaven / kg body weight per hour, which is equivalent to 0.05 g fish oil/kg body weight per hour.
The maximum infusion rate should be closely monitored as a sharp rise in serum triglyceride concentration may otherwise occur.
The omega should be given together with other fat emulsions. Fish oil from Omegaven should make up 10-20% of a recommended total daily lipid intake of 1-2 g / kg body weight.
If you take more Omegaven than you should
It is very unlikely that you will receive too much infusion fluid as your doctor or nurse will monitor you during treatment. See section 4 “Possible side effects” for information on what symptoms you may experience from an overdose. If you think you may have received too much Omegaven, tell your doctor or nurse immediately. If this happens, the infusion will be stopped immediately. It may be possible to continue treatment with a reduced dose. The symptoms will usually go away when the dose is reduced or the infusion is stopped.
Ask your doctor if you have any further questions about the use of this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are observed when administering Omegaven
| Rare (may affect up to 1 in 1,000 people) | Prolonged bleeding time and impaired blood clotting ( coagulation ).A fish-like taste in the mouth |
Side effects are observed when administering fat emulsions
| Uncommon (may affect up to 1 in 100 people) | Abdominal pain, nausea, vomitingElevated body temperature, chills, chills, fatigueHypertriglyceridemia (high levels of triglycerides in the blood)Headache |
| Very rare (may affect up to 1 in 10,000 people) | Anaphylactic reaction (severe allergy -like reaction that significantly increases body temperature and difficulty breathing)Skin rash , urticaria _Effects on blood circulation, e.g. high blood pressure ( hypertension ) or low blood pressure ( hypotension )Abnormal blood counts ( thrombocytopenia , hemolysis , reticulocytosis)Temporarily elevated values during liver function testsLasting, usually painful, erection |
Be observant of signs of fat overload. The cause may be genetic (individual difference in metabolism) or due to a previous disease. However, this condition has mainly been observed when using emulsions with cottonseed oil.
Fat overload can cause the following symptoms:
- liver enlargement ( hepatomegaly ) with or without jaundice (skin turns yellow)
- change or decrease in certain coagulation values (eg bleeding time, coagulation time, prothrombin time, platelet count )
- enlarged spleen ( splenomegaly )
- abnormal blood counts – anemia , low white blood cell count
- bleeding and bleeding tendency
- abnormal values in liver function tests
- fever
- high blood fat levels ( hyperlipidemia )
- headache, abdominal pain, fatigue
- high blood sugar ( hyperglycaemia )
If any of these side effects occur, your infusion will be stopped or, if necessary, continued with a reduced dose.
Overdose can lead to a fat overload syndrome :
This can occur when your body has trouble taking care of fat when you have received too much Omegaven. It can also occur due to a sudden change in your condition (such as a kidney problem or an infection ). Signs of this can be fever, dysfunction of various organs, and unconsciousness. All symptoms usually go away when the infusion is stopped.
A severe overdose of Omegaven without concomitant administration of carbohydrate solution may lead to metabolic acidosis.
Tell your doctor if any of the side effects gets worse or if you notice any side effects not listed in this leaflet.
How to store the Omegaven
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. 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.
Contents of the pack and other information
Content declaration
The active substances are:
| 100 ml emulsion contains: | |
| Highly purified fish oilcontaining:-Eicosapentaenoic acid (EPA)-Docose hexaenoic acid (DHA)-dl-α-Tocopherol (antioxidant) GlycerolPurified egg phosphate time | 10.0 g 1.25 – 2.82 g1.44 – 3.09 g0.015 – 0.0296 g 2.5 g1.2 g |
– The other ingredients are:
Sodium oleate,
Sodium hydroxide,
Water for injections.
| Total energy content: | 470 kJ / 100 ml = 112 kcal / 100 ml |
| pH value: | 7.5 to 8.7 |
| Titratable acidity: | <1 mmol HCl / liter |
| Osmolality: | 308 – 376 mosm / kg |
What the medicine looks like and contents of the pack
Infusion solution , emulsion – white, homogeneous emulsion .
Glass vials (type II, colorless) and bromobutyl rubber stopper.
Pack sizes: 1 x 50 ml, 10 x 50 ml, 1 x 100 ml, 10 x 100 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Holder of approval for sale
Fresenius Kabi AB
751 74 Uppsala
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz, Austria