Kefamycin Vet. intramammær salve

Land: Danmark

Sprog: dansk

Kilde: Lægemiddelstyrelsen (Danish Medicines Agency)

Aktiv bestanddel:

Bacitracin, BENZYLPENICILLINKALIUM, NEOMYCIN

Tilgængelig fra:

Pharmaxim Sweden AB

ATC-kode:

QJ51RC

INN (International Name):

Bacitracin, BENZYLPENICILLINKALIUM, NEOMYCIN

Lægemiddelform:

intramammær salve

Terapeutisk gruppe:

Kvæg

Produktets egenskaber

17 JUNE 2016
SUMMARY OF PRODUCT CHARACTERISTICS
FOR
NANOSCAN, KIT FOR RADIOPHARMACEUTICAL PREPARATION
1.
NAME OF THE MEDICINAL PRODUCT
NanoScan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Human Serum Albumin nano sized colloid 500 micrograms.
At least 95 % of human albumin colloidal particles have a diameter ≤
80 nm.
NanoScan 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)
The radionuclide is not part of the kit.
Excipient(s) with known effects:
Sodium: 0.045 mmol
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation.
White powder.
Powder for solution for injection.
To be reconstituted with sodium pertechnetate (
99m
Tc) solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with sodium (
99m
Tc) pertechnetate solution, the solution obtained is
indicated in adults, children aged 1 to 18 years and neonates for:
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_Intravenous administration:_

Bone marrow scanning (The product is not suitable to study the
haematopoietic
activity of the bone marrow)

Inflammation scanning in areas other than the abdomen
_Subcutaneous administration:_

Conventional lymphoscintigraphy to demonstrate integrity of the
lymphatic system
and differentiation of venous from lymphatic obstruction

Sentinel node detection in:
o
Melanoma malignum
o
Breast cancer
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Recommended activities in adults are as follows:
-
Bone marrow scanning: 185-500 MBq as a single intravenous injection.
-
Inflammation scanning: 370-500 MBq as a single intravenous injection.
_Subcutaneous administration:_
-
Conventional lymphoscintigraphy: The recommended activity by single or
mu