Fat emulsion (intravenous)

Fat emulsion (intravenous)

Fat emulsion (intravenous)

Use for fat emulsion

This medicine should only be administered by or under your doctor's direct supervision.

Before using fat emulsion

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of Omegaven® in children. However, undesirable effects occur more frequently in children (e.g. restlessness, slow heartbeat, vomiting). Safety and effectiveness have been demonstrated in children.

Related studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of Intralipid® in children.

geriatrics

No relevant studies have been conducted on the association of age with the effects of Omegaven® in the elderly.

There is no information regarding the association of age with the effects of Intralipid® in geriatric patients.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. Tell your doctor if you are taking other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergie gegen Ei-, Fisch- oder Sojaproteine, Olivenöl oder Distelöl oder
• Blutungsstörung, schwere oder
• Hyperlipidämie (hohe Triglyceride oder Fette im Blut), schwere oder
• Schwere Fettstoffwechselstörungen: Sollte bei Patienten mit diesen Erkrankungen nicht angewendet werden.

• Blutprobleme bzw
• Diabetes bzw
• Lebererkrankung bzw
• Lungen- oder Atemprobleme oder
• Pankreatitis (Entzündung oder Schwellung der Bauchspeicheldrüse), Vorgeschichte: Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Elektrolytungleichgewicht bzw
• Flüssigkeitsstörung bzw
• Schwere Stoffwechselstörungen – sollten vor der Einnahme dieses Arzneimittels behoben werden.

• Hypertriglyceridämie (hohe Triglyceride oder Fette im Blut) – Mit Vorsicht anwenden. Kann das Risiko von Bauchspeicheldrüsenproblemen erhöhen.

• Infektion – Kann die Fähigkeit Ihres Körpers, Infektionen zu bekämpfen, beeinträchtigen.

• Nierenerkrankung – Mit Vorsicht verwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

• Bei stark unterernährten Patienten kann es zu einem Refeeding-Syndrom kommen. Überwachen und steigern Sie die Nährstoffaufnahme der Patienten langsam.

Proper use of fat emulsion

A nurse or other trained health professional will give this medicine to you or your child in a medical facility. It can be used individually or added to your baby's TPN bag. It is given through a needle inserted into one of your veins.

Precautions when using fat emulsion

It is very important that your doctor closely monitors you or your child's progress while you are receiving this medicine. This will help your doctor determine whether the medicine is working properly. Blood and urine tests are required to check for adverse effects.

This drug may cause acute respiratory distress syndrome and metabolic acidosis in neonates and infants following rapid infusion. Contact your doctor immediately if your child has blue lips, fingernails, or skin, has difficulty, confusion, sleepiness, rapid breathing, muscle tremors, nausea, restlessness, stomach cramps, or unusual tiredness or weakness.

This medicine can cause serious allergic reactions. Consult your doctor immediately if you have bluish discoloration of your fingernails, lips, skin, palms, or nail beds, blurred vision, chest tightness, confusion, cough, dizziness, fainting or lightheadedness when standing up suddenly from lying or sitting, fast, pounding, or irregular heartbeat or pulse, nausea, sweating, difficulty breathing, unusual tiredness or weakness, or vomiting.

This medicine may increase your risk of developing infections. Avoid being around sick or infected people while you or your child are receiving this medicine. Wash your hands often. Tell your doctor if you have an infection before you start taking this medicine. Also tell your doctor if you have ever had an infection that didn't go away or an infection that keeps coming back.

Call your doctor immediately if you or your child experiences a persistent cough, weight loss, night sweats, fever, chills, or flu-like symptoms such as a runny or stuffy nose, headache, blurred vision, etc. or feeling generally ill. These may be signs that you have an infection.

This medicine may cause a rare condition called fat overload syndrome. Tell your doctor right away if you or your child have fever, chills, cough, sore throat, pain and fullness in the right upper abdomen or stomach, and unusual bleeding, bruising, or weakness.

Call your doctor if you or your child has redness, swelling, pain, or infection at the injection site.

This medicine can cause electrolyte imbalance, fluid overload, and aluminum toxicity (too much aluminum in the blood), which can damage the brain and be life-threatening. Talk to your doctor if you have concerns.

Before you have a medical examination, tell your doctor that you are receiving this medicine. The results of some tests may be affected by this medicine.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Side effects of fat emulsion

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Ansammlung von Eiter
• schwarzer, teeriger Stuhl
• Blasenschmerzen
• blutiger oder trüber Urin
• bläuliche Lippen oder Haut
• Brustschmerzen oder Unwohlsein
• Schüttelfrost
• Husten
• Durchfall
• schwieriges, brennendes oder schmerzhaftes Wasserlassen
• übermäßiger Muskeltonus
• Fieber
• häufiger Harndrang
• allgemeines Unwohlsein oder Krankheitsgefühl
• Kopfschmerzen
• Heiserkeit
• Gelenkschmerzen
• Benommenheit, Schwindel oder Ohnmacht
• Appetitverlust
• Schmerzen im unteren Rücken oder an der Seite
• Muskelschmerzen, Steifheit, Verspannungen oder Verspannungen
• Brechreiz
• blasse Haut
• laufende Nase
• Zittern
• langsamer oder unregelmäßiger Herzschlag
• Halsentzündung
• Schwitzen
• Geschwollener, roter, empfindlicher Infektionsbereich
• Schlafstörungen
• Geschwüre, Wunden oder weiße Flecken im Mund
• ungewöhnliche Blutungen oder Blutergüsse
• ungewöhnliche Müdigkeit oder Schwäche
• Erbrechen

Rarely

• Rückenschmerzen
• schneller Herzschlag
• Nesselsucht

Incident not known

• Zahnfleischbluten
• blaue Lippen, Fingernägel oder Haut
• Veränderungen der Hautfarbe
• Veränderungen beim Wasserlassen
• Engegefühl in der Brust
• Verwirrung
• Blut husten
• Schwierigkeiten beim Atmen oder Schlucken
• Schläfrigkeit
• Fruchtartiger Atemgeruch
• erhöhter Menstruationsfluss oder vaginale Blutungen
• Erhöhter Durst
• Muskelkrämpfe oder Zittern
• Taubheitsgefühl, Kribbeln, Schmerzen oder Schwäche in den Händen oder Füßen
• Nasenbluten
• Lähmung
• längere Blutungen aus Schnittwunden
• Ausschlag
• roter oder dunkelbrauner Urin
• roter oder schwarzer, teeriger Stuhl
• Unruhe
• Magenschmerzen oder Krämpfe
• Schwellung und Rötung im Unterschenkel
• Atembeschwerden

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Agitation
• Rötung der Haut
• Rötung, Schwellung oder Schmerzen an der Injektionsstelle

Less common

• Juckende Haut

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Clinolipid
• Liposyn
• Omegaven

Available dosage forms:

• Emulsion

Therapeutic Class: Parenteral Lipids

More information