Ferrosig

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Iron polymaltose 50 mg/mL (318mg iron polymaltose equivalent to 100mg iron III)

متاح من:

Multichem NZ Limited

INN (الاسم الدولي):

Iron polymaltose 50 mg/mL (318mg iron polymaltose equivalent to 100mg iron III)

جرعة:

50 mg/mL

الشكل الصيدلاني:

Solution for injection

تركيب:

Active: Iron polymaltose 50 mg/mL (318mg iron polymaltose equivalent to 100mg iron III) Excipient: Hydrochloric acid Sodium hydroxide Water for injection

الوحدات في الحزمة:

Ampoule, glass, 5 x 2 mL, 5 dose units

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Biofer SpA

ملخص المنتج:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 2 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 12 hours diluted stored at or below 25°C protect from light

تاريخ الترخيص:

2002-11-27

نشرة المعلومات

Page 1

NEW ZEALAND CONSUMER MEDICINE INFORMATION 
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_(Iron polymaltose injection) _

WHAT IS IN THIS LEAFLET? 
This leaflet answers some 
common questions about 
FERROSIG INJECTION. 
It does not contain all the 
available information. 
It does not take place of talking 
to your doctor or pharmacist. 
All medicines have risks and 
benefits. 
Your doctor has weighed the 
risks of using FERROSIG 
INJECTION against the 
benefits this medicine is 
expected to have for you. 
IF YOU HAVE ANY CONCERNS 
ABOUT THIS MEDICINE, ASK 
YOUR DOCTOR OR PHARMACIST. 
KEEP THIS LEAFLET WITH YOUR 
MEDICINE.  You may need to 
read it again. 
WHAT IS FERROSIG 
INJECTION? 
The name of your medicine is 
FERROSIG Injection.  
FERROSIG injection is an iron 
supplement. 
_It contains iron in a form that _
_can be used by your body to _
_build up iron reserves that are _
_needed for your system to _
_operate properly. _
WHAT IS FERROSIG 
INJECTION USED FOR? 
FERROSIG INJECTION is 
used in cases of iron 
deficiency (too little iron in the 
system).  
FERROSIG INJECTION is 
used when dosage by mouth is 
impractical, the anaemia is 
severe or disturbances in the 
gastro-intestinal tract make 
absorption difficult or 
uncertain. 
FERROSIG INJECTION is 
also used for treating iron 
deficiency states discovered in 
the third trimester of 
pregnancy and in 
circumstances where contact 
between patient and doctor 
only occurs at irregular 
intervals. 
Your doctor however, may 
have prescribed and used 
FERROSIG INJECTION for 
another reason. 
ASK YOUR DOCTOR IF YOU HAVE 
ANY QUESTIONS ABOUT WHY 
FERROSIG INJECTION HAS 
BEEN PRESCRIBED FOR YOU. 
A doctor's prescription is 
required for FERROSIG 
INJECTION. 

BEFORE YOU ARE GIVEN 
FERROSIG INJECTION 
_When you must not be given _
_it: _
DO NOT USE FERROSIG 
INJECTION IF YOU HAVE EVER 
HAD AN A

خصائص المنتج

NEW ZEALAND DATA SHEET
FERROSIG
Page 1 of 10
1. PRODUCT NAME
Ferrosig, Solution for Injection, 50 mg/mL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2 mL ampoule of Ferrosig Solution for Injection contains 318 mg
iron polymaltose equivalent
to 100 mg iron III.
3. PHARMACEUTICAL FORM
A slightly viscous dark reddish brown liquid. Odour faintly malt-like.
Each 2 mL ampoule of Ferrosig
contains the equivalent of 100 mg of iron.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prevention and treatment of iron deficiency anaemia when oral
preparations are
contraindicated or in the following circumstances:
•
When enteric absorption of iron is defective
•
When patient non-compliance or persistent gastrointestinal intolerance
makes oral therapy
impractical.
The diagnosis must be based on laboratory tests. Intravenous use is
only recommended for use
in hospitals when the intramuscular route is impractical or
unacceptable and when tests show
that the bone marrow has no stored iron.
4.2
DOSE AND METHOD OF ADMINISTRATION
(A)
METHOD OF ADMINISTRATION
INTRAMUSCULAR USE
TECHNIQUE OF INJECTION: THE TECHNIQUE OF INJECTION IS OF CRUCIAL
IMPORTANCE. IRON POLYMALTOSE
SHOULD NEVER BE INJECTED INTO THE ARM OR OTHER EXPOSED AREAS. THE
WRONG INJECTION TECHNIQUE MAY
RESULT IN PAIN AND PERSISTENT DISCOLOURATION OF THE SKIN.
The following method of ventro-gluteal injection according to
HOCHSTETTER is recommended
instead of the normal method of injection in the top outer quadrant of
the gluteus maximus
muscle:
1. The length of the needle should be at least 5 - 6 cm. The lumen of
the needle should not be too
wide.
2. The site of injection is determined as follows (see Fig. 1): First
point A is found, corresponding
to the ventral iliac spine. If the patient lies on the right side, for
instance, the middle finger of
the left hand is placed on point A. The index finger is extended away
from the middle finger, so
that it comes to lie below the iliac crest, at point B. The triangle
lying between the proximal
phalanges of the mid