Normosang 25mg/ml, Concentrate for solution for infusion

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

HUMAN HEMIN

זמין מ:

Recordati Rare Disease Immeuble “Le Wilson”, 70, avenue du Général de Gaulle, F-92800 Puteaux, France

קוד ATC:

B06AB

INN (שם בינלאומי):

HUMAN HEMIN 25 mg/ml

טופס פרצבטיות:

CONCENTRATE FOR SOLUTION FOR INFUSION

הרכב:

HUMAN HEMIN 25 mg/ml

סוג מרשם:

POM

איזור תרפויטי:

OTHER HEMATOLOGICAL AGENTS

מצב אישור:

Authorised

תאריך אישור:

2006-11-10

עלון מידע

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORMOSANG 25 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
Human hemin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NORMOSANG is and what it is used for
2.
What you need to know before you use NORMOSANG
3.
How to use NORMOSANG
4.
Possible side effects
5.
How to store NORMOSANG
6.
Contents of the pack and other information
1.
WHAT NORMOSANG IS AND WHAT IT IS USED FOR
NORMOSANG contains human hemin, which is a substance derived from
human blood.
NORMOSANG is used to treat sudden attacks that occur in patients
suffering from acute hepatic
porphyria; the disease is characterized by liver accumulation of
compounds (including porphyrins
and its toxic precursors). There are three types of hepatic porphyria
whose medical names are:
acute intermittent porphyria, porphyria variegata and hereditary
coproporphyria. This accumulation
leads to symptoms of the disease including pain (mainly abdomen, back
and thighs), nausea,
vomiting and constipation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NORMOSANG
DO NOT USE NORMOSANG:
-
if you are allergic to human hemin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS

Before treatment with NORMOSANG, your doctor should confirm an attack
of hepatic
porphyria by series of clinical and biological criteria :

suggestive family or personal history;

suggestive clinical signs;

quantitative determination of delta-amino-laevulinic acid and
porphobilinogen (specific
markers of the disease) in urines.

The sooner NORMOSANG treatment is started after the onset of an
attack, the greater its
efficacy.
Page 2 of 6

As a

מאפייני מוצר

Page 1 of 8
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.
Page 2 of 8
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 to flush the vein initially with 3 to 4 bolus injections
of 10 ml 0.9 % NaCl