Solcoseryl solution for i/v injection

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

hemodialysate from calves blood protein-free

Доступно од:

Legacy Pharmaceuticals Switzerland GmbH

АТЦ код:

առկա չէ(V03AX)

INN (Међународно име):

hemodialysate from calves blood protein-free

Дозирање:

42,5mg/ml

Фармацеутски облик:

solution for i/v injection

Јединице у пакету:

(5/1x5/) ampoules 5ml in blister

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2020-03-26

Карактеристике производа

MEDA Pharmaceuticals Switzerland GmbH
Hegnaustrasse 60, CH-8602 Wangen-Brüttisellen
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SOLCOSERYL® Injection Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Active ingredient:_
Protein
‐
free haemodialysate of calf blood (_Bos taurus_), chemically and
biologically standardized
_Excipients:_
Methyl-p-hydroxybenzoate (E 218), propyl-p-hydroxybenzoate (E 216),
ethyl-p-hydroxybenzoate (E 214), p-hydroxybenzoic acid, water for
injections
3.
GALENIC FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT
1 ml of Solcoseryl Injection Solution (_i.v._) contains 42.5 mg
protein
‐
free haemodialysate of
calf blood (_Bos taurus_), chemically and biologically standardised
1 ampoule of 2 ml contains 85 mg protein
‐
free haemodialysate of calf blood, chemically and
biologically standardised
1 ampoule of 5 ml contains 212.5 mg protein
‐
free haemodialysate of calf blood, chemically
and biologically standardised
4.
CLINICAL PARTICULARS
4.1 INDICATIONS AND USAGE
Peripheral arterial occlusive disease (PAOD) in stages III/IV in
patients with
contraindications for or intolerance of other vasoactive drugs;
Chronic venous insufficiency with therapy
‐
resistant leg ulcers
4.2 DOSAGE AND ADMINISTRATION
If appropriate to the clinical condition of the patient, it is
recommended that Solcoseryl is
administered as an intravenous infusion whenever possible and not as
an intravenous
injection. Solcoseryl Injection Solution must not be administered as a
bolus injection.
When administered as an infusion or an injection, Solcoseryl Injection
Solution should be
diluted in a ratio of at least 1:1 with a sodium chloride or glucose
solution or with a mixed
glucose/sodium chloride solution and administered slowly. Solcoseryl
Injection Solution
should not be diluted with potassium
‐
containing infusion solutions.
Infusion:
Whenever possible, Solcoseryl should be administered as an intravenous
infusion, in
particular if the total volume of the diluted solution is more than