Venticoll 0.5 mg

Land: Norge

Språk: norsk

Kilde: Statens legemiddelverk

Aktiv ingrediens:

Albumin, humant, kolloidale partikler

Tilgjengelig fra:

GE Healthcare AS

ATC-kode:

V09DB01

INN (International Name):

Albumin, human, kolloidale particles

Dosering :

0.5 mg

Legemiddelform:

Pulver til inhalasjonsvæske til nebulisator, oppløsning

Enheter i pakken:

Hetteglass 5x0.5 mg

Resept typen:

C

Autorisasjon status:

Markedsført

Autorisasjon dato:

1999-09-20

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
VENTICOLL kit for radiopharmaceutical preparation
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin colloidal particles 500 micrograms /vial
At least 95% of human albumin colloidal particles have a diameter

80 nm.
VENTICOLL is prepared from human serum albumin derived from human
blood donations tested
according to the EEC Regulations and found non reactive for:
– Hepatitis B surface antigen (HBsAg)
– Antibodies to human immunodeficiency virus (anti-HIV 1/2)
– Antibodies to hepatitis C virus (anti-HCV).
VENTICOLL is reconstituted with Sodium Pertechnetate (
99m
Tc) solution to prepare
technetium-99m albumin nanocolloid injection. The radionuclide is not
a part of the kit.
Excipient with known effect:
Sodium: 0.24 mg/ml
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
Powder for nebuliser solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Aerosol administration.
After reconstitution with Sodium Pertechnetate (
99m
Tc) solution, the solution obtained is indicated
for:
– Diagnosis of pulmonary embolism, in combination with perfusion
studies.
– Semi quantitative assessment of pulmonary ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
Depending upon the type of nebulizer, an amount of volume and activity
of the radiopharmaceutical
should be introduced in order to obtain about 30 MBq deposed in the
lungs. Ventilation scanning is
done immediately after nebulizing.
Perfusion scanning may be performed immediately after the acquisition
of satisfactory ventilation
images.
Renal/hepatic impairment
Careful consideration of the activity to be administered is required
since an increased radiation
exposure is possible in these patients.
Paediatric population
The use in children and adolescents has to be considered carefully,
based upon clinical needs and
assessing the risk/benefit ratio in this p