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In section 3 added text – "engraved on one side"In Section 4.1 - change to text –
In Section 4.1 - change to text –
Carbaglu is indicated in treatment of
In section 4.2 - added text –
- For isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia:
The treatment should start upon hyperammonaemia in organic acidaemia patients. The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary.
It should then be individually adjusted in order to maintain normal ammonia plasma levels (see section 4.4).
In section 4.6 - change to title –“Fertility” has been added
In section 4.8 – sentence deleted –
“Clinical experience has been collected in about 170 patient-years.”
In section 4.8 - text added –
- Undesirable effects in N-acetylglutamate synthase deficiency
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Investigations
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Uncommon: increased transaminases
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Skin and subcutaneous tissue disorders
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Common: increased sweating
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- Undesirable effects in organic acidaemia
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Cardiac disorders
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Uncommon: bradycardia
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Gastrointestinal disorders
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Uncommon: diarrhoea, vomiting
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General disorders and Administration site conditions
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Uncommon: pyrexia
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In section 5.1 – text added-
“In patients with organic acidaemia (neonates and non-neonates), the treatment with carglumic acid induced a quick decrease of ammonia plasma levels, reducing the risk of neurological complications.”
In section 6.5 text changed -
“5-, 15- or 60- polypropylene tablet containers closed by a polyethylene cap with a desiccant unit.
Not all pack sizes may be marketed.”
In section 7 – Address change –
Orphan Europe SARL
Immeuble “Le Wilson”
70 avenue du Général de Gaulle
F-92800 Puteaux
France
In section 8 - Text added –
EU/1/02/246/001 (15 dispersible tablets)
EU/1/02/246/002 (60 dispersible tablets)
EU/1/02/246/003 (5 dispersible tablets)
In section 10 – date changed –
27th May 2011
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