Normosang 250mg/10ml solution for infusion ampoules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Haem arginate

Διαθέσιμο από:

Recordati Rare Diseases UK Ltd

Φαρμακολογική κατηγορία (ATC):

n/a

INN (Διεθνής Όνομα):

Haem arginate

Δοσολογία:

25mg/1ml

Φαρμακοτεχνική μορφή:

Solution for infusion

Οδός χορήγησης:

Intravenous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 09080200; GTIN: 3663502000649

Αρχείο Π.Χ.Π.

OBJECT 1
NORMOSANG
Summary of Product Characteristics Updated 26-Sep-2017 | Orphan Europe
(UK) Limited
1. Name of the medicinal product
NORMOSANG 25 mg/ml, concentrate for solution for infusion.
2. Qualitative and quantitative composition
Human hemin
...........................................................................................................................25
mg/ml.
One ampoule of 10 ml contains 250 mg of human hemin.
After dilution of one 10 ml ampoule in 100 ml of 0.9% Na Cl solution,
the diluted solution contains 2273
micrograms per ml of human hemin.
Excipient with known effect: ethanol 96% (1 g / 10 ml) (see section
4.4).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
NORMOSANG is a dark coloured concentrate for solution for infusion.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of acute attacks of hepatic porphyria (acute intermittent
porphyria, porphyria variegata,
hereditary coproporphyria).
4.2 Posology and method of administration
Posology
The recommended daily dose is 3 mg/kg once daily for four days,
diluted in 100 ml of 0.9% sodium
chloride in a glass bottle and infused intravenously over at least 30
minutes into a large antebrachial or
central vein using an inline filter.
The dose should not exceed 250 mg (1 ampoule) per day.
Exceptionally, the course of the treatment may be repeated under
strict biochemical surveillance if there
is inadequate response after the first course of treatment.
_Elderly patients_
No dose adjustment is required.
_Children and adolescents_
Attacks of porphyria are rare in children but limited experience in
tyrosinaemia suggests that it is safe to
use a dose of not more than 3 mg/kg daily for 4 days, administered
with the same precautions as for
adults.
Method of administration
The infusions should be administered in a large antebrachial or
central vein over a period of at least 30
minutes. After the infusion, the vein should be rinsed with 100 ml of
0.9 % NaCl. It is recommended