Ferrum H

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Iron polymaltose 50 mg/mL (159mg/ml iron hydroxide polymaltose complex =50mg/ml iron)

Հասանելի է:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Միջազգային անվանումը):

Iron polymaltose 50 mg/mL (159mg/ml iron hydroxide polymaltose complex =50mg/ml iron)

Դոզան:

100mg/2mL

Դեղագործական ձեւ:

Solution for injection

Կազմը:

Active: Iron polymaltose 50 mg/mL (159mg/ml iron hydroxide polymaltose complex =50mg/ml iron) Excipient: Hydrochloric acid Sodium hydroxide Water for injection

Միավորները փաթեթում:

Ampoule, glass, 2ml, 5 dose units

Դաս:

Prescription

Ռեկվիզորի տեսակը:

Prescription

Պատրաստված է:

Vifor (International) Inc

Թերապեւտիկ ցուցումներ:

For the prevention and treatment of iron deficiency anaemia in the following circumstances: · When oral therapy is contraindicated · When enteric absorption of iron is defective · When patient non-compliance or persistent gastrointestinal intolerance makes oral therapy impractical · Treating iron deficiency anaemia of prematurity and that occurring in geriatric patients · Treating iron deficiency states discovered in the third trimester of pregnancy · Anaemia resulting from excessive blood loss · Where contact between the doctor and patient occurs at irregular intervals

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Ampoule, glass, 2ml - 5 dose units - 36 months from date of manufacture stored at or below 25°C

Հաստատման ամսաթիվը:

1969-12-31

Տեղեկատվական թերթիկ

FERRUM H
®
Iron Polymaltose
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about FERRUM H. It
does not contain all the
available information. It does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of using FERRUM H
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 FERRUM H IS USED FOR
FERRUM H provides a source of iron that can help to replenish a
shortage of iron in patients with
iron deficiency.
FERRUM H is used when dosage by mouth is impractical or
contraindicated and when disturbances
in the gastrointestinal tract make absorption difficult or uncertain.
BEFORE YOU ARE GIVEN FERRUM H
WHEN YOU MUST NOT BE GIVEN IT
DO NOT USE FERRUM H IF:

You are known to be sensitive (allergic) to any of the ingredients of
FERRUM H

Your anaemia is not due to a shortage of iron

You have a condition known as haemochromatosis (an excess of iron in
the body)

You have any medical conditions or health problems including
arthritis, bronchial asthma,
hepatitis

You are in the 1
st
trimester of a pregnancy
FERRUM H should not be used after the expiry date printed on the
label.
PAGE 2/5
CONSUMER MEDICINE INFORMATION FERRUM H
PIL-YA460/AU/E04
IF YOU ARE NOT SURE WHETHER YOU SHOULD BE GIVEN FERRUM H PLEASE TALK
TO YOUR DOCTOR.
BEFORE YOU ARE GIVEN IT_ _
YOU SHOULD BE AWARE THAT:

A blood test should have been carried out to ensure treatment with
this medicine is
appropriate

If you have a history of asthma, eczema or other atopic allergies you
are more susceptible to
experience allergic reactions
YOU MUST TELL YOUR DOCTOR IF:

You are pregnant or breastfeeding

You or a blood relative have the condition haemochromatosis

You have a history of_ _liver disease
IF YOU HAVE NOT TOLD YOUR DOCTOR ABOUT ANY O

Ապրանքի հատկությունները

NEW ZEALAND DATA SHEET
1. FERRUM H SOLUTION FOR INJECTION 100 MG/2ML AMPOULE
FERRUM H solution for injection 100 mg/2mL ampoule.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Iron polymaltose equivalent to iron 100 mg/2 mL.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A slightly viscous, dark reddish brown liquid. Odour faintly
malt-like. Each ampoule of FERRUM H contains the
equivalent of 100 mg of iron.
The aqueous colloidal solution is sterile, pyrogen-free and
approximates the pH and tonicity of the tissues.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of iron deficiency anaemia in the
following circumstances:
•
When oral therapy is contraindicated
•
When enteric absorption of iron is defective
•
When patient non-compliance or persistent gastrointestinal intolerance
makes oral therapy impractical
•
Treating iron deficiency anaemia of prematurity and that occurring in
geriatric patients
•
Treating iron deficiency states discovered in the third trimester of
pregnancy
•
Anaemia resulting from excessive blood loss
•
Where contact between the doctor and patient occurs at irregular
intervals
4.2 DOSE AND METHOD OF ADMINISTRATION
INTRAMUSCULAR USE
_TECHNIQUE OF INJECTION _
THE TECHNIQUE OF INJECTION IS OF CRUCIAL IMPORTANCE. FERRUM H 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 fr