ОМЕГАВЕН 50 ML Эмульсия для внутривенного введения
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Инструкция по применению OMEGAVEN
Содержание инструкции
OMEGAVEN
Emulsion for infusion
Read this leaflet carefully before you start to use this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Omegaven is and what it is used for
- 2. What you need to know before Omegaven is given
- 3. How Omegaven is given
- 4. Possible side effects
- 5. How to store Omegaven
- 6. Contents of the pack and other information
1. What is Omegaven and what is it used for
Omegaven provides energy and omega-3 fatty acids derived from fish oil through the bloodstream when oral nutrition is not possible, is insufficient, or is not recommended.
2. What you need to know before Omegaven is given
Do not receive Omegaven
- If you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6)
- If you are allergic (hypersensitive) to fish or egg proteins
- If you have severe coagulation disorders
- If you have had collapses with shock
- If you have recently had a severe heart attack
- If you have recently had a severe stroke
- If you have been told you have a severe embolism (blockage of the arteries)
- If you suffer from low potassium levels (hypokalaemia)
- If you have too much fluid in your body (hyperhydration)
- If you are dehydrated with low sodium levels (hypotonic dehydration)
- If your metabolism is unstable
- If you have acidosis (the levels of acid in body fluids and tissues become too high)
- If you suffer from severe liver or kidney failure
This medicine should not be given to you if you are in an undefined comatose state.
Warnings and precautions
Talk to your doctor before using Omegaven if you suffer from:
- Diabetes (type 1 and 2)
- A condition in which the body has difficulty using fats properly.
If you are taking medicines to thin the blood (anticoagulants), your doctor may want to perform
regular blood tests to ensure that your anticoagulant therapy is well controlled.
Serum triglyceride levels may be monitored daily and its concentration should not
exceed 3 mmol/l during the infusion of 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 are taking
- Medicines used in anticoagulant therapy to thin the blood (such as heparin).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine
There is no information on the safety of this medicine during pregnancy or breastfeeding.
This medicine should only be taken during pregnancy and breastfeeding if strictly
necessary.
3. How Omegaven is administered
The medicine will be administered to you by infusion.
The doctor will decide the correct dose for you and the infusion rate. This will depend on your body weight in
kilograms and your body's ability to utilize fats. The infusion will be administered to you in
hospital by a healthcare professional.
The duration of administration should not exceed 4 weeks.
Dosage
Daily dose:
1 ml up to a maximum of 2 ml of Omegaven/kg of body weight = 0.1 g up to a maximum of 0.2 g of fish oil/kg of body weight = 70 ml up to a maximum of 140 ml of Omegaven for a patient with a
body weight of 70 kg.
Maximum infusion rate:
the infusion rate should not exceed 0.5 ml of Omegaven/kg of body weight/hour which
corresponds to 0.05 g of fish oil/kg of body weight/hour.
The maximum infusion rate must be carefully respected otherwise a significant increase in serum triglyceride concentration may be observed.
Omegaven must be administered in association with other lipid emulsions. Based on the
total daily lipid amount recommended of 1-2 g/kg of body weight, the portion of fish oil from Omegaven must constitute 10-20% of that amount.
If you receive too much Omegaven
It is unlikely that you will receive a larger infusion than you should receive as your doctor
or nurse will monitor you during treatment.
For symptoms of overdose see section 4 “Possible undesirable effects”. If you think you have
received too much Omegaven inform your doctor or nurse immediately. If this happens, the infusion will
be stopped immediately. It is possible to continue with a reduced dose. These symptoms
will generally disappear with a reduction in the rate or with stopping the infusion.
If you have any questions about the use of this product ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects observed during the administration of Omegaven
Side effects observed during the administration of lipid emulsions
| a Rare (may affect up to 1 in 1,000 people) i |
|
| t I Uncommon (may affect up to 1 in 100 people) a i |
|
| z n Very rare (may affect up to 1 in 10,000 people) e g A |
|
Possible symptoms of metabolic overload must be observed. The cause may be genetic
(different metabolism from individual to individual) or depend on a previous illness.
However, this is observed mainly with the use of cottonseed oil emulsions.
Metabolic overload can lead to the following symptoms:
- Enlargement of the liver (hepatomegaly) with or without jaundice (yellowing of the skin)
- Changes or reduction in some coagulation parameters (e.g. bleeding time, coagulation time, prothrombin time, platelet count)
- Enlargement of the spleen (splenomegaly)
- Irregularity of blood anaemia, low white blood cell count
- Bleeding and tendency to bleed
- Tests for liver function pathologies
- Fever
- Elevated levels of lipids in the blood (hyperlipidaemia)
- Headache, stomach pain, fatigue
- Elevated blood sugar levels (hyperglycaemia)
If any side effect occurs, the infusion must be stopped or, if necessary,
continued at reduced doses.
An overdose may occur leading to lipid overload syndrome.
This can happen when the body has difficulty using fats, due to excess
Omegaven. It can also occur due to a rapid change in conditions (such as kidney problems or infections). Possible symptoms are fever, problems in various organs of the body and coma. All these
symptoms will disappear when the infusion is stopped.
A severe overdose of Omegaven without the simultaneous administration of carbohydrate solutions can lead to metabolic acidosis.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing more information on the safety of this medicine.
5. How to store Omegaven
Keep this medicine out of the sight and reach of children.
Do not use Omegaven after the expiry date stated on the label after “Scad”. The expiry date
refers to the last day of the month.
liver function or
|
Do not store at a temperature above 25°C. Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Omegaven contains:
The active ingredients are:
100 ml of emulsion contain:
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) 0.015-0.0296 g
Glycerol 2.5 g
Purified egg phospholipid 1.2 g
The other ingredients are
sodium oleate
sodium hydroxide
water for injections.
Total caloric value:470 kJ/100ml = 112 kcal/100ml
pH value 7.5-8.7
Titratable acidity: < 1 mmol HCl/l
Osmolality 308-376 mOsm/kg
Description of the appearance of Omegaven and contents of the pack
Emulsion for infusion, homogeneous white emulsion.
Glass vials (type II, colorless) and bromobutyl rubber stoppers.
Packs: 1x50ml, 10x50ml, 1x100ml, 10x100 ml.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Fresenius Kabi Deutschland GmbH
61346 Bad Homburg v.d.H. Germany
Manufacturer
Fresenius Kabi Austria GmbH
8055 Graz, Austria
Representative in Italy and importer
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala
Verona
This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
The following information is intended for healthcare professionals only:
The usual daily dose is:
1 ml up to max 2 ml of Omegaven/kg of body weight = 0.1 g up to max 0.2 g of fish oil/kg of
body weight = 70 ml up to max 140 ml of Omegaven for a patient with a weight of 70 kg.
The infusion rate should not exceed 0.5 ml of Omegaven/kg of body weight/hour, which
corresponds to 0.05 g of fish oil/kg of body weight/hour.
The maximum infusion rate must be strictly observed, otherwise a significant increase in serum
triglyceride concentration may be observed.
| Austria | Omegaven "Fresenius" - Emulsion zur Infusion |
| Bulgaria | Omegaven |
| Czech Republic | Omegaven Fresenius |
| Denmark | Omegaven |
| Estonia | d Omegaven |
| France | Omegaven |
| Germany | Omegaven Fresenius |
| Hungary | a Omegaven |
| Italy | n Omegaven |
| Latvia | Omegaven |
| Lithuania | a Omegaven |
| Luxembourg | i Omegaven |
| Netherlands | l Omegaven Fresenius |
| Poland | a Omegaven |
| Portugal | Omegaven Fresenius |
| Romania | t Omegaven |
| Slovakia | I Omegaven |
| Slovenia | Omegaven 10% |
| a Sweden | Omegaven |
| i United Kingdom | Omegaven |
Omegaven must be administered in association with other lipid emulsions. Based on the
recommended daily intake of lipids of 1-2 g/kg, the portion of fish oil from
Omegaven should constitute 10-20% of this amount.
Route of administration:
For intravenous infusion via central or peripheral vein.
The vials must be shaken before use. Use only if the emulsion is homogeneous and the container
is not damaged.
If possible, infusion sets that do not contain phthalates should be used for administration. Any
residual contents and mixtures after use must be discarded.
Incompatibilities
When Omegaven is administered with other infusion solutions (e.g. amino acid solutions, carbohydrate solutions) through a common infusion line (by-pass, Y-piece), the compatibility (tolerance) of the solutions/emulsions used must be ensured.
Incompatibilities may occur with 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 category: emulsion for parenteral nutrition
ATC code: B05BA02
The long-chain omega-3 fatty acids present in Omegaven are partially incorporated into the lipids
of plasma and tissues.
Docosahexaenoic acid is an important structural element in phospholipid membranes while
eicosapentaenoic acid is a precursor in the synthesis of a special class of eicosanoids
(prostaglandins, thromboxanes, leukotrienes and other lipid mediators). An increase in the synthesis of
these mediating substances of eicosapentaenoic acid derivatives can help to promote anti-aggregating and anti-inflammatory effects, and is associated with immunomodulatory effects.
The glycerol contained in Omegaven is designated for the use in energy production through
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 cell membranes, where they are essential for maintaining membrane integrity.
Pharmacokinetic properties
The lipid particles administered with Omegaven are similar in size and elimination to
physiological chylomicrons. In healthy male volunteers, a half-life of triglycerides for
Omegaven was calculated to be 54 minutes.
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- Страна регистрации
- Форма выпускаEmulsion for intravenous infusion, 50 ML
- Код АТХB05BA02
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги OMEGAVENФорма выпуска: Emulsion for intravenous infusion, 20 %Действующее вещество: fat emulsionsПроизводитель: BAXTER S.P.A.Отпускается по рецептуФорма выпуска: Emulsion for intravenous infusion, 200 MG/MLДействующее вещество: fat emulsionsПроизводитель: B. BRAUN MELSUNGEN AGОтпускается по рецептуФорма выпуска: Emulsion for intravenous infusion, 5 G + 5 G/100 MLДействующее вещество: fat emulsionsПроизводитель: B. BRAUN MELSUNGEN AGОтпускается по рецепту
Аналоги OMEGAVEN в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог OMEGAVEN в Польша
Аналог OMEGAVEN в Украина
Аналог OMEGAVEN в Испания
Врачи онлайн по OMEGAVEN
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
OMEGAVEN требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество OMEGAVEN — fat emulsions. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
OMEGAVEN производится компанией FRESENIUS KABI DEUTSCHLAND GMBH. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения OMEGAVEN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить OMEGAVEN в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (fat emulsions) включают KLINOLEIK, LIPIDEM, LIPOFUNDIN MKT. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
