Venofer

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Iron sucrose 540 mg/mL Equivalent to iron 20 mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Iron sucrose 540 mg/mL (Equivalent to iron 20 mg/mL)

Dosage:

20 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Iron sucrose 540 mg/mL Equivalent to iron 20 mg/mL Excipient: Water for injection

Units in package:

Ampoule, glass, 5mL, 5 dose units

Class:

Pharmacy only

Prescription type:

Prescription

Manufactured by:

Vifor (International) Inc

Therapeutic indications:

Venofer is indicated for the treatment of iron deficiency in the following indications: · Where there is a clinical need for a rapid iron supply, · In patients who cannot tolerate oral iron therapy or who are non-compliant, · In active inflammatory bowel disease where oral iron preparations are ineffective.

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2002-12-20

Patient Information leaflet

2023-09-26_Venofer_AU_CMI
1
VENOFER®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING VENOFER?
VENOFER provides a source of iron that can help to replenish a
shortage of iron in patients with iron deficiency. For more
information, see Section 1. Why am I using VENOFER? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VENOFER?
Do not use if you have ever had an allergic reaction to VENOFER or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use VENOFER? in the full
CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines, such as iron tablets and VENOFER may interfere with
each other. A list of these medicines is in Section 3.
What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE VENOFER?
Your doctor or nurse will prepare this medicine for you. VENOFER is a
sterile solution which is diluted immediately before use.
It is given by intravenous infusion or by slow injection into the
venous limb of the dialysis line for haemodialysis patients. More
instructions can be found in Section 4. How do I use VENOFER? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VENOFER?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VENOFER.
THINGS YOU SHOULD
NOT DO
•
Do not take VENOFER if your anaemia is not due to shortage of iron.
•
Do not take VENOFER if you are in the first trimester of pregnancy.
•
Do not take VENOFER if you have a condition known as haemo-chromatosis
(an excess of iron in the
body) or a genetic tendency towards this condition.
DRIVING OR USING
MACHINES
Be careful before you drive or use any machines or tools until you
know how VENOFER affects you.
DRINKING ALCOHOL
Tell your docto

Summary of Product characteristics

2023-11-03_Venofer_NZ_DS
Page 1 of 12
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
VENOFER
®
20 mg/mL solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule contains 20 mg/mL iron as iron sucrose (iron(III)
hydroxide
sucrose complex) corresponding to 100 mg iron per ampoule.
For the full list of excipients see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Solution for injection.
VENOFER is a dark brown, non transparent, sterile aqueous solution of
iron sucrose
in water for injections with a pH of 10.5 - 11.0 and an osmolarity of
1,150 - 1,350
mOsmol/L.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Venofer is indicated for the treatment of iron deficiency in the
following indications:
•
Where there is a clinical need for a rapid iron supply,
•
In patients who cannot tolerate oral iron therapy or who are
non-compliant,
•
In
active
inflammatory
bowel
disease
where
oral
iron
preparations
are
ineffective.
Venofer should only be administered where the indication is confirmed
by appropriate
investigations (e.g. Hb, serum ferritin, serum iron).
4.2 DOSE AND METHOD OF ADMINISTRATION
_DOSE _
The cumulative dose of Venofer must be calculated for each patient
individually and
must not be exceeded.
_CALCULATION OF DOSAGE _
The total cumulative dose of Venofer, equivalent to the total iron
deficit (mg), is
determined by the haemoglobin level (Hb) and body weight (BW). The
dose of Venofer
2023-11-03_Venofer_NZ_DS
Page 2 of 12
must be individually calculated for each patient according to the
total iron deficit
calculated with the following Ganzoni formula, for example:
TOTAL IRON DEFICIT [MG] = BW [KG] X (TARGET HB-ACTUAL HB) [G/L] X
0.24* + STORAGE
IRON [MG]
Below 35 kg BW:
Target Hb = 130 g/L and storage iron = 15 mg/kg BW
35 kg BW and above:
Target Hb = 150 g/L and storage iron = 500 mg
*
Factor 0.24 = 0.0034 (iron content of Hb = 0.34%) x 0.07 (blood volume
= 7% of BW) x
1000 (conversion of [g] to [mg])
Total Venofer to be administered (in mL)=
(Total iron deficit [mg])
(20 mg i