Examples of using Ammonaps in English and their translations into German
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How is Ammonaps used?
Other information about Ammonaps.
How has Ammonaps been studied?
The overall survival ratewas about 80% in newborn babies who received Ammonaps.
Ammonaps 500 mg outer packaging only.
What benefit has Ammonaps shown during the studies?
Ammonaps was not compared with any other treatments.
It is recommended that AMMONAPS granules are used instead.
Ammonaps contains the active substance sodium phenylbutyrate.
Studies in patients have been limited to tests to determine thatPheburane is bioequivalent to the reference medicine, Ammonaps.
AMMONAPS tablets should be taken with a large volume of water.
Pregnancy and breast-feeding Do not use AMMONAPS if you are pregnant, since this medicine could harm your unborn baby.
AMMONAPS may be required life-long unless orthotopic liver transplantation is elected.
The Committee for Medicinal products for Human Use(CHMP) decided that Ammonaps effectively prevents ammonia levels to become too high in patients who have urea cycle disorders.
What AMMONAPS looks like and contents of the pack AMMONAPS granules are off-white.
It has not been determined if phenylacetate is secreted in human milk andtherefore the use of AMMONAPS is contra-indicated during lactation see section 4.3.
If you forget to take AMMONAPS You should take a dose as soon as possible with your next meal.
The Committee for Medicinal Products for Human Use(CHMP) noted that urea cycle disordersare a serious disease with few treatments available, and that Ammonaps has been shown to prevent ammonia levels becoming too high.
The active substance in Ammonaps, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Since the metabolism and excretion of sodium phenylbutyrate involves the liver andkidneys, AMMONAPS should be used with caution in patients with hepatic or renal insufficiency.
Ammonaps is a long-term treatment and needs to be taken until the patient has a successful liver transplant.
Where AMMONAPS granules need to be added to food, liquid or water, it is important that it is taken immediately after mixing.
Ammonaps should not be used in people who may be hypersensitive(allergic) to sodium phenylbutyrate or any of the other ingredients.
Ammonaps treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Ammonaps was authorised under"Exceptional Circumstances", because, as the disease is rare, limited information was available at the time of approval.
AMMONAPS tablets should not be used in patients with dysphagia due to the potential risk of oesophageal ulceration if tablets are not promptly delivered to the stomach.
Ammonaps has been studied in 82 patients with urea cycle disorders who were treated with Ammonaps and had not received other treatments for their disease before.
Ammonaps can also be used in patients over one month old who have partial lack of enzymes or have a history of hyperammonaemic encephalopathy brain damage caused by high levels of ammonia.
Ammonaps is taken in divided doses at meal times, by mouth, mixed with food or through a gastrostomy(tube through the abdomen to the stomach) or nasogastric tube tube through the nose to the stomach.
Ammonaps may also cause decreased appetite, abnormal blood acidity, depression, irritability, headache, fainting, fluid retention, bad taste or taste aversion, abdominal pain, vomiting, nausea, constipation, rash, unpleasant body odour, or weight gain.