REFERIS IRON SUCROSE INJECTION USP 100MG5ML

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Commercializzato da:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Nome Internazionale):

IRON (III)- HYDROXIDE SUCROSE COMPLEX

Confezione:

5ml x 5ampoule Ampoules

Prodotto da:

Maiva Pharma Private Limited

Foglio illustrativo

Not Applicable

Scheda tecnica

ARTWORK SIZE:
80 mm x 220 mm
CONTRAINDICATIONS
The use of Referis is contraindicated in cases of:
• Iron overload or disturbances in utilization of iron (e.g.
haemochromatosis, haemosiderosis)
• Anemic conditions not caused by iron deficiency (e.g. haemolytic
anaemias)
• Known hypersensitivity to Iron mono-, disaccharide complexes, Iron
Sucrose Injection or any of its
components.
• Hypersensitivity to the active substance, to Referis or any of its
excipients.
WARNINGS & PRECAUTIONS
Referis is a strong alkaline solution, hence never be administrated by
the subcutaneous or intramuscular
route. Paravenous leakage must be avoided because leakage of Referis
at the injection site may lead to
pain, inflammation, tissue necrosis and brown discoloration of the
skin. In case of inadvertent paravenous
leakage, while the needle is still inserted, rinse with a small amount
of 0.9% w/v Sodium chloride Injection.
Injection of Referis parenterally can cause allergic or anaphylactic
reactions, which may be potentially
fatal. In the event of allergic reaction, administration of Referis
must be stopped and antihistamines and/or
corticosteroids should be administered immediately. Referis should
only be administered when staff
trained to evaluate and manage anaphylactic reactions is immediately
available and in an environment
where full resuscitation facilities can be assured. Each patient
should be observed for adverse effects for
at least 30 minutes following each injection.
Hypotensive episodes may occur if the injection is administered too
rapidly. Allergic reactions, sometimes
involving arthralgia, have been more commonly observed when the
recommended dose is exceeded. The
risk is enhanced for patients with known allergies including patients
with a history of severe asthma,
eczema or other atopic allergy. Patients with low iron binding
capacity and/or folic acid deficiency are
particularly at risk of an allergic or anaphylactic reaction.
Referis should not be administrated in combination with oral iron
preparations and m