Soluferr solution for i/v injection or concentrate for solution for infusion

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

iron (III)-hydroxide sucrose complex

Mevcut itibaren:

Help S.A. Pedini

ATC kodu:

առկա չէ (B03AC)

INN (International Adı):

iron (III)-hydroxide sucrose complex

Doz:

20mg/ml

Farmasötik formu:

solution for i/v injection or concentrate for solution for infusion

Paketteki üniteler:

(5) ampoules 5ml

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2021-04-21

Ürün özellikleri

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
_▼_
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
_ _
1.
NAME OF THE MEDICINAL PRODUCT
SOLUFERR 20 mg/ ml, solution for injection or concentrate for solution
for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Each 5 ml ampoule contains 100 mg iron as iron sucrose (iron
(III)-hydroxide sucrose complex; 20 mg
iron per ml)
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion.
SOLUFERR is a dark brown, non transparent, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SOLUFERR is indicated for the treatment of iron deficiency in the
following indications:
•
where there is a clinical need to deliver iron rapidly to iron stores,
•
in patients who cannot tolerate oral iron therapy or who are
non-compliant,
•
in active inflammatory bowel disease where oral iron preparations are
ineffective.
The diagnosis of iron deficiency must be based on appropriate
laboratory tests (e.g. Hb, serum ferritin,
serum iron, etc.).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and following
each administration of SOLUFERR.
SOLUFERR should only be administered when staff trained to evaluate
and manage anaphylactic
reactions is immediately available, in an environment where full
resuscitation facilities can be assured.
The patient should be observed for adverse effects for at least 30
minutes following each SOLUFERR
injection (see section 4.4).
ADMINISTRATION:
SOLUFERR must only be administered by the intravenous route. This may
be by a
slow intravenous injection or by an intravenous drip infusion.
SOLUFERR must not be used for