Monoctanoin (injection)

Monoctanoin (injection)

Monoctanoin (injection)

Uses for Monoctanoin

Monoctanoin is only given by or under your doctor's supervision.

Before using monoctanoin

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 of this medicine have only been conducted in adult patients and there is no specific information comparing the use of monoctanoin in children with use in other age groups.

geriatrics

Many drugs have not been specifically studied in older people. Therefore, it may not be known whether they work the same way as they do in younger adults or whether they cause different side effects or problems in older people. There is no specific information comparing the use of monoctanoin in the elderly with use in other age groups.

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 around the time of eating or consuming 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:

• Verstopfung des Gallengangs – Das Risiko schwerwiegender Nebenwirkungen kann erhöht sein

• Probleme mit den Gallenwegen (andere) oder
• Gelbsucht bzw
• Pankreatitis (Entzündung der Bauchspeicheldrüse) – Monoctanoin kann diese Erkrankungen verschlimmern

• Zwölffingerdarmgeschwür (kürzlich) oder
• Darmprobleme – Monoctanoin kann diese Erkrankungen verschlimmern und das Blutungsrisiko erhöhen

• Lebererkrankung (schwerwiegend) – Unerwünschte Wirkungen können auftreten, wenn die Leber nicht richtig funktioniert

Correct use of monoctanoin

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für die Bewässerungsdosierungsform:
  • Bei Gallensteinerkrankungen:
    • Erwachsene und Jugendliche – Die übliche Dosis beträgt 3 bis 5 Milliliter (ml) pro Stunde, verabreicht über einen Katheter oder Schlauch. Die Dosis wird über einen Zeitraum von 2 bis 10 Tagen verabreicht.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Side effects of monoctanoin

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 as soon as possible if any of the following side effects occur:

Less common or rare

• Bauch- oder Magenschmerzen (stark)
• Rückenschmerzen (schwer)
• Schüttelfrost, Fieber oder Halsschmerzen
• Schläfrigkeit (schwer)
• Übelkeit (anhaltend)
• Kurzatmigkeit (schwerwiegend)

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

• Bauch- oder Magenschmerzen (leicht) oder Brennen

Less common or rare

• Rückenschmerzen (leicht)
• Durchfall
• Gesichtsrötung oder Rötung
• Appetitverlust
• metallischer Geschmack
• Übelkeit oder Erbrechen

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.

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