VENOFER 20 MG/ML SOLN FOR INJ OR CONC. FOR SOLN FOR INFUSION

Active substance: IRON SUCROSE

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Venofer 20 mg iron/ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
Read all of this leaflet carefully before
you are given this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, please
ask your doctor.
• If any of the side effects becomes serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Venofer is and what it is used for
2. Before Venofer is given to you
3. How Venofer is given
4. Possible side effects
5. How to store Venofer
6. Further information

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines
obtained without a prescription, including
herbal medicines. This is because Venofer
can affect the way some other medicines
work. Also some other medicines can
affect the way Venofer works.
In particular tell your doctor or pharmacist
if you are taking:
• Medicines that contain iron which you
take by mouth. These may not work if
they are taken at the same time that
V
­ enofer is given to you. When you have
finished treatment with Venofer, wait 5
days before taking iron by mouth.

Venofer is a medicine that contains iron.

Pregnancy and breast-feeding
Venofer should not be given during the first
three months of pregnancy.

Medicines that contain iron are used when
you do not have enough iron in your body.
This is called “iron deficiency”.

Your doctor will decide if Venofer can be
used during the fourth to ninth months of
preg­ ancy.
n

1.  HAT Venofer IS AND WHAT IT
W
IS USED FOR

Venofer is given when:
• You cannot take iron by mouth – such as
when iron tablets make you feel ill.
• You have taken iron by mouth – and it
has not worked.

2. BEFORE Venofer IS GIVEN TO YOU

Perforation

You must not be given Venofer if:
• You are allergic (hypersensitive) to any
of the ingredients of Venofer (listed in
Section 6).
• You have anaemia which is not caused
by a shortage of iron.
• You have too much iron in your body or a
problem in the way your body uses iron.
• You have ever had asthma, eczema or
other allergies. This is because you are
more likely to have an allergic reaction.
• You are in the first three months of pregnancy.
You must not be given Venofer if any of the
above apply to you. If you are not sure, talk
to your doctor before having Venofer.

It is unlikely that Venofer can pass into the
mother’s milk. Therefore breast-feeding
when you are being given this medicine
should not harm your baby.
Ask your doctor or pharmacist for advice
before taking any medicine, if you are
pregnant or breast-feeding.
Driving and using machines
You may feel dizzy, confused or lightheaded after being given Venofer. If this
happens, do not drive or use any tool or
machines. Ask your doctor if you are not
sure.

3. HOW Venofer IS GIVEN
Venofer will be given to you by a doctor.
Your doctor will decide how much Venofer
to give you. He or she will also decide how
often you need it and for how long. Your
doctor will do a blood test to help work out
the dose.

Take special care with Venofer
Check with your doctor before you are
given Venofer if:
• You have any infections.
• You have liver problems.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before you are given Venofer.

If you have never had Venofer before, you
will have a small amount of the medicine
first (a test dose). This is to check that you
are not allergic to it.

The following information
is intended for medical or
healthcare professionals only:

Intravenous drip infusion:
Venofer must be diluted only in sterile
0.9% m/V sodium chloride solution:
• 2.5 ml Venofer (50 mg iron) in max. 50 ml
sterile 0.9% m/V sodium chloride
s
­ olution
• 5 ml Venofer (100 mg iron) in max. 100 ml
sterile 0.9% m/V sodium chloride
s
­ olution
• 10 ml Venofer (200 mg iron) in max. 200 ml
sterile 0.9% m/V sodium chloride
s
­ olution

Administration
Mode of Administration:
Venofer must only be administered as a
slow intravenous injection or as an intravenous drip infusion. Venofer must not be
used for intramuscular injection. Before
administering the first dose to a new
p
­ atient, a test dose of Venofer should be
given.
Treatment for serious allergic reactions
and facilities with the established cardiopulmonary resuscitation procedures
should be available because allergic or
anaphylactoid reactions and hypotensive
episodes may occur.
Paravenous leakage must be avoided be­
cause leakage of Venofer at the injection
site may lead to pain, inflammation, tissue
necrosis and brown discoloration of the
skin.

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How Venofer is given
Venofer can be given in 3 different ways:
• Slow injection into your vein – 1 to 3
times per week.

For stability reasons, dilutions to lower
V
­ enofer concentrations are not permis­
sible.
Dilution must take place immediately prior
to infusion and the solution should be
adminis­ ered as follows:
t
• 100 mg iron (5 ml Venofer) over at least
15 minutes
• 200 mg iron (10 ml Venofer) over at least
30 minutes

Pf 530-00

Perforation



PACKAGE LEAFLET: INFORMATION FOR THE USER

vial 2.5ml and vial 5ml
pI
Manufacturer GP Grenzach

• As an infusion (drip) into your vein – 1 to
3 times per week.
• During dialysis – it will be put into the
venous limb of the dialyser.
Venofer is a brown liquid and so the injection or infusion will look brown.
Children
Venofer is not recommended for use in
chil­ ren.
d

4. POSSIBLE SIDE EFFECTS
Like all medicines, Venofer can cause side
effects, although not everybody gets them.
Allergic reactions (affects less than 1 in
1,000 people)
If you have an allergic reaction, tell your
doctor or nurse straight away. The signs
may include:
• Low blood pressure (feeling dizzy, lightheaded or faint).
• Swelling of your face.
• Difficulty breathing.
Tell your doctor or nurse straight away if
you think you are having an allergic
r a
­ e­ ction.
Other side effects include:
Common (affects less than 1 in 10 people)
• Changes in your taste such as a metallic
taste. This does not usually last very
long.
Uncommon (affects less than 1 in 100 people)
• Fast pulse rate.
• Headache or feeling dizzy.
• Low blood pressure and collapse.
• Pounding heart beat (palpitations).
• Stomach pain or diarrhoea.
• Feeling sick (nausea) or being sick
(vomit­ng).
i
• Wheezing, difficulty in breathing.
• Itching, hives, rash or skin redness.
• Muscle cramps or muscle pain.





Flushing.
Fever or shivering.
Chest pain and chest tightness.
Reactions around the site of injection
such as inflammation, a feeling of burn­
ing and swelling.

Perforation

Rare (affects less than 1 in 1,000 people)
• Fainting.
• Loss of consciousness.
• Tingling or “pins and needles”.
• A feeling of burning.
• High blood pressure.






Feeling hot.
Swelling (dropsy).
Pain in your joints.
Swelling of hands and feet.
Tiredness, weakness or general feeling
of illness.

Intravenous injection:
Venofer may be administered by slow intravenous injection at a rate of 1 ml undiluted
solution per minute and not exceeding
10 ml Venofer (200 mg iron) per injection.
Before administering a slow intravenous
injection, a test dose of 1 ml (20 mg iron)
should be injected slowly over a period of 1
to 2 minutes. If no adverse reactions occur
within 15 minutes of completing the test
dose, then the remaining portion of the
injection may be given.
Injection into the dialyser:
Venofer may be administered during a haemodialysis session directly into the venous
limb of the dialyser under the same procedures as those outlined for intravenous
injection.

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If any of the side effects becomes serious,
or if you notice any side effects not listed in
this leaflet, please tell your doctor.

5. HOW TO STORE Venofer
Keep out of the reach and sight of chil­
dren.
Do not use Venofer after the expiry date
which is stated on the label.
Do not store above 25 °C. Do not freeze.
Keep the ampoules or vials in the outer
carton.
Once the Venofer ampoules or Venofer
vials have been opened, they should be
used immediately. After dilution with sodium chloride solution, the diluted solution
should be used immediately.
Venofer will normally be stored for you by
your doctor or the hospital.

6. FURTHER INFORMATION
What Venofer contains
• The active substance is iron (as iron
s crose). Each millilitre contains 20 mg
­ u­­
iron.
• The other ingredients are water for
injections and sodium hydroxide.
What Venofer looks like and contents of
the pack
Venofer is a dark brown, non transparent,
aqueous solution.
Venofer comes in following pack-sizes:
• 5 Glass ampoules of 5 ml. Each ampoule
of 5 ml corresponds to 100 mg of iron.
• 5 Glass vials of 2.5 ml. Each vial of 2.5 ml
corresponds to 50 mg of iron.
• 5 Glass vials of 5 ml. Each vial of 5 ml corresponds to 100 mg of iron.
Not all pack-sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Vifor France SA
7–13, Bd Paul Emile Victor
92200 Neuilly-sur-Seine, France
Tél. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
This leaflet was approved in: 02/2011
For any information about this medicine,
please contact the local representative of
the Marketing Authorisation Holder.
Vifor Pharma UK Limited
The Old Stables, Bagshot Park
Bagshot
Surrey
GU19 5PJ
United Kingdom
Tel: +44 1276 853600
Fax : +44 1276 452341

Incompatibilities
Venofer must only be mixed with sterile
0.9% m/V sodium chloride solution. No
other solutions and therapeutic agents
should be used, as there is the potential for
precipita­ ion and/or interaction. The comt
patibility with containers other than glass,
polyethylene and PVC is not known.
Stability
The product must not be used after the
expiry date which is stated on the label and
on the outer carton. From a microbiological
point of view, the product should be used
immediately after first opening or immedi­
ately after dilution with sterile 0.9% m/V
sodium chloride.
Instruction for use and handling
Ampoules/Vials should be visually inspected for sediment and damage before use.
Only those with sediment free and homogenous solution must be used. The dilution
solution must appear as brown and clear.
Any unused product or waste material
should be disposed of in accordance with
local requirements.
Pf 530-00

Perforation

The first 25 mg of iron (i. e. 25 ml of solution)
should be infused as a test dose over a
period of 15 minutes. If no adverse reactions occur during this time then the
re­ aining portion of the infusion should be
m
given at an infusion rate of not more than
50 ml in 15 minutes.

Other side effects include: feeling less
alert, light-headed or confused; swelling of
your joints, face and tongue; increased
sweating; back pain; low pulse rate;
changes to the colour of your urine.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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