FERINJECT

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

FERRIC CARBOXYMALTOSE

থেকে পাওয়া:

CTS LTD

ফার্মাসিউটিকাল ফর্ম:

SOLUTION FOR INJECTION / INFUSION

রচনা:

FERRIC CARBOXYMALTOSE 1800 MG/VIAL

প্রশাসন রুট:

I.V

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

VIFOR (INTERNATIONAL) INC, SWITZERLAND

থেরাপিউটিক ইঙ্গিত:

Ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests.

অনুমোদন তারিখ:

2016-06-30

তথ্য লিফলেট

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
FERINJECT SOLUTION FOR INJECTION/INFUSION 50 MG/ML
THE ACTIVE INGREDIENT AND ITS CONCENTRATION:
Each 10 ml of solution contains 500 mg iron (as 1800 mg ferric
carboxymaltose)
For a list of the inactive and allergenic ingredients in the
preparation - see Section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even if it
seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of iron deficiency when oral iron preparations are
ineffective or cannot be used.
The diagnosis must be based on laboratory tests.
THERAPEUTIC GROUP: Iron, preparations for the treatment of anaemia
2. BEFORE USING THE MEDICINE:
X DO NOT USE THE MEDICINE IF:

You are sensitive (allergic) to ferric carboxymaltose or to any of the
other ingredients contained in the
medicine (see Section 6).

You have had a severe allergic reaction (hypersensitivity) to other
injectable iron preparations.

You have anaemia that is not caused by a shortage of iron.

You have too much iron in your body or a problem in the way your body
utilises iron..
! SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE COMMENCING THE TREATMENT WITH FERINJECT, INFORM THE DOCTOR IF
YOU HAVE:

A history of sensitivity to medicines.

Systemic lupus erythematosus.

Rheumatoid arthritis.

Severe asthma, eczema or other allergies.

Any infections.

Liver problems.

Low levels of phosphate in the blood.
Incorrect administration of Ferinject may cause leakage of the
substance at the administration site, which may
lead to skin irritation and even long-lasting skin discolouration at
the administration si

পণ্য বৈশিষ্ট্য

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ferinject 50 mg iron/mL solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 50 mg of iron as 180 mg ferric
carboxymaltose.
Each 10 mL vial contains 500 mg of iron as 1800 mg ferric
carboxymaltose.
Excipient(s) with known effect
One mL of solution contains up to 5.5 mg (0.24 mmol) sodium, see
section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Dark brown, non-transparent, aqueous solution inside a dark brown
vial.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ferinject is indicated for treatment of iron deficiency when oral iron
preparations are ineffective or
cannot be used.
The diagnosis of iron deficiency must be based on laboratory tests.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Monitor carefully patients for signs and symptoms of hypersensitivity
reactions during and
following each administration of Ferinject.
Ferinject 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 Ferinject administration (see section 4.4).
_ _
Posology
The posology of Ferinject follows a stepwise approach: [1]
determination of the individual iron
need, [2] calculation and administration of the iron dose(s), and [3]
post-iron repletion
assessments. These steps are outlined below:
_ _
_Step 1: Determination of the iron need _
_ _
The individual iron need for repletion using Ferinject is determined
based on the patient's body
weight and haemoglobin (Hb) level. Refer to Table 1 for determination
of the iron need:
TABLE 1: DETERMINATION OF THE IRON NEED
HB
PATIENT BODY WEIGHT
G/DL
MMOL/L
BELOW 35 KG
35 KG TO <70 KG
70 KG AND ABOVE
<10
<6.2
500 mg
1,500 mg
2,000 mg
10 to <14
6.2 to <8.7
500 mg
1,000 mg
1,500 mg
>14
>8.7
50