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

Active substance(s): IRON SUCROSE / IRON SUCROSE / IRON SUCROSE

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Venofer® CTD-YA539/UK/E01

Package leaflet: Information for the user

Venofer 20 mg iron /ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
medicine is subject to additional
   This
monitoring. This will allow quick identifi-

Other medicines and Venofer
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription, including herbal medicines.

Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your
doctor.
– If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.

This is because Venofer can affect the way
some other medicines work. Also some other
medicines can affect the way Venofer works.

What is in this leaflet
1. What Venofer is and what it is used for
2. What you need to know before Venofer is
given to you
3. How Venofer is given
4. Possible side effects
5. How to store Venofer
6. Contents of the pack and other information

Pregnancy and breast-feeding
Venofer has not been tested in women who are
in the first three months of their pregnancy. It is
important to tell your doctor if you are pregnant,
think you may be pregnant, or are planning to
have a baby.
If you become pregnant during treatment, you
must ask your doctor for advice.
Your doctor will decide whether or not you
should be given this medicine.

cation of new safety information. You can
help by reporting any side effects you may
get. See the end of section 4 for how to
report side effects.

1.  What Venofer is and what it is used
for
Venofer is a medicine that contains iron.

Medicines that contain iron are used when you
do not have enough iron in your body. This is
called “iron deficiency”.
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.  What you need to know before
Venofer is given to you

You must not receive Venofer if:
– You are allergic (hypersensitive) to the product or any of the other ingredients of this
medicine (listed in section 6).
– You have experienced serious allergic
(hypersensitive) reactions to other injectable
iron preparations.
– 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 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.

Perforation

Warnings and precautions
Talk to your doctor or nurse before receiving
Venofer if:
– You have a history of medicine allergy.
– You have systemic lupus erythematosus.
– You have rheumatoid arthritis.
– You have severe asthma, eczema or other
allergies.
– 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.

Administration
Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and
following each administration of Venofer.
Venofer 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 Venofer administration.
Mode of Administration:
Venofer must only be administered by the intravenous route. This may be by drip infusion, slow
injection or directly into the venous line of the
dialysis machine.
Paravenous leakage must be avoided because
leakage of Venofer at the injection site may lead
to pain, inflammation and brown discoloration of
the skin.

F.1/xxxxxxx

V_Pf_431_03_GB_Takeda_Version_06.indd 1

Vifor (International) Ltd.

If you are breast-feeding, ask your doctor for
advice before you are given Venofer.
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 light-headed
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

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.
Your doctor or nurse will administer Venofer in
one of the following ways:
– Slow injection into your vein – 1 to 3 times per
week.
– As an infusion (drip) into your vein – 1 to 3
times per week.
– During dialysis – it will be put into the venous
line of the dialysis machine.
Venofer will be administered in a structure
where immunoallergic events can receive
appropriate and prompt treatment.
You will be observed for at least 30 minutes by
your doctor or nurse after each administration.
Venofer is a brown liquid and so the injection or
infusion will look brown.
Use in children
Venofer is not recommended for use in children.

4.  Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Intravenous drip infusion:
Venofer must only be diluted in sterile 0.9% m/V
sodium chloride (NaCl) solution. Dilution must
take place immediately prior to infusion and the
solution should be administered as follows:
Venofer
dose
(mg of
iron)

Venofer
dose
(ml of
Venofer)

Maximum
dilution
volume of
sterile
0.9% m/V
NaCl solution

Minimum
Infusion
Time

50 mg
100 mg
200 mg

2.5 ml
5 ml
10 ml

50 ml
100 ml
200 ml

8 minutes
15 minutes
30 minutes

For stability reasons, dilutions to lower Venofer
concentrations are not permissible.
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.
Injection into venous line of dialysis machine:
Venofer may be administered during a haemo­
dialysis session directly into the venous line of
the dialysis machine under the same conditions
as for intravenous injection.
Pf 431-03

08.08.16 15:34

Perforation

The following information is intended
for healthcare professionals only:

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 Venofer is given
to you.

Venofer® CTD-YA539/UK/E01

Allergic reactions (may affect up to 1 in 100 people)
If you have an allergic reaction, tell your doctor
or nurse straight away. The signs may include:
• Low blood pressure (feeling dizzy, light-headed or faint).
• Swelling of your face.
• Difficulty breathing.
Tell your doctor or nurse straight away if you
think you are having an allergic reaction.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Changes in your taste such as a metallic
taste. This does not usually last very long.
• Low blood pressure or high blood pressure.
• Feeling sick (nausea).
• Reactions around the site of injection/infusion such as pain, irritation, itching, haematoma or discolouration following the leakage
of the injection into the skin.
Uncommon (may affect up to 1 in 100 people)
• Headache or feeling dizzy.
• Stomach pain or diarrhoea.
• Being sick (vomiting).
• Wheezing, difficulty in breathing.
• Itching, rash.
• Muscle spasms, cramps or pain.
• Tingling or “pins and needles”.
• Reduced sensation of touch.
• Vein inflammation.
• Flushing, burning sensation.
• Constipation.
• Joint pain.
• Pain in limbs.
• Back pain.
• Chills.
• Weakness, tiredness.
• Swelling of hands and feet.
• Pain.
• Increased levels of liver enzymes (ALT, AST,
GGT) in the blood.
• Increased serum ferritin levels.
Rare (may affect up to 1 in 1,000 people)
• Fainting.
• Sleepiness or drowsiness.
• Pounding heart beat (palpitations).
• Changes to the colour of your urine.
• Chest pain.
• Increased sweating.
• Fever.
• Increased lactate dehydrogenase in the
blood.
Other side effects with unknown frequency
include: feeling less alert, feeling confused; loss
of consciousness; anxiety; trembling or shaking;
swelling of your face, mouth, tongue or throat
which may cause difficulty in breathing; low
pulse rate; fast pulse rate; circulatory collapse;
vein inflammation causing the formation of a
blood clot; acute narrowing of the airways; itching, hives, rash or skin redness; cold sweat; general feeling of illness; pale skin; sudden lifethreatening allergic reactions.

Perforation

Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more information on the safety of this medicine.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL– Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5.  How to store Venofer

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label after EXP.
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 imme­
diately.
Venofer will normally be stored for you by your
doctor or the hospital.

6.  Contents of the pack and other
information

What Venofer contains
• The active substance is iron (as iron sucrose).
Each millilitre contains 20 mg 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
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tél. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
This leaflet was last revised in 07/2016
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

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Shelf life and storage
Do not use this medicine after the expiry date
which is stated on the carton after EXP. Do not
store above 25 °C. Do not freeze. Store in the
original package.

Instruction for use and handling
Ampoules or vials should be visually inspected
for sediment and damage before use. Use only
those containing a sediment free and homogenous solution. The diluted solution must appear
as brown and clear.
Any unused product or waste material should be
disposed of in accordance with local requirements.

Shelf life after first opening of the container
From a microbiological point of view, the product should be used immediately.
Shelf life after dilution with the sterile 0.9% m/V
sodium chloride (NaCl) solution
From a microbiological point of view, the pro­duct should be used immediately after dilution.

F.1/xxxxxxx

V_Pf_431_03_GB_Takeda_Version_06.indd 2

Vifor (International) Ltd.

Pf 431-03

08.08.16 15:34

Perforation

Incompatibilities
Venofer must not be mixed with other medicinal
products except sterile 0.9% m/V sodium chloride solution. There is the potential for precipitation and/or interaction if mixed with other solutions or medicinal products. The compatibility
with containers other than glass, polyethylene
and PVC is not known.

Venofer® CTD-YA539/UK/E01

Package leaflet: Information for the user

Venofer 20 mg iron /ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
medicine is subject to additional
   This
monitoring. This will allow quick identifi­

Other medicines and Venofer
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription, including herbal medi­
cines.

Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your
doctor.
– If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.

This is because Venofer can affect the way
some other medicines work. Also some other
medicines can affect the way Venofer works.

What is in this leaflet
1. What Venofer is and what it is used for
2. What you need to know before Venofer is
given to you
3. How Venofer is given
4. Possible side effects
5. How to store Venofer
6. Contents of the pack and other information

Pregnancy and breast-feeding
Venofer has not been tested in women who are
in the first three months of their pregnancy. It is
important to tell your doctor if you are pregnant,
think you may be pregnant, or are planning to
have a baby.
If you become pregnant during treatment, you
must ask your doctor for advice.
Your doctor will decide whether or not you
should be given this medicine.

cation of new safety information. You can
help by reporting any side effects you may
get. See the end of section 4 for how to
report side effects.

1.  What Venofer is and what it is used
for
Venofer is a medicine that contains iron.

Medicines that contain iron are used when you
do not have enough iron in your body. This is
called “iron deficiency”.
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.  What you need to know before
Venofer is given to you

You must not receive Venofer if:
– You are allergic (hypersensitive) to the prod­
uct or any of the other ingredients of this
medicine (listed in section 6).
– You have experienced serious allergic
(hypersensitive) reactions to other injectable
iron preparations.
– 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 must not be given Venofer if any of the above
apply to you. If you are not sure, talk to your doc­
tor before having Venofer.

Perforation

Warnings and precautions
Talk to your doctor or nurse before receiving
Venofer if:
– You have a history of medicine allergy.
– You have systemic lupus erythematosus.
– You have rheumatoid arthritis.
– You have severe asthma, eczema or other
allergies.
– 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.

Administration
Monitor carefully patients for signs and symp­
toms of hypersensitivity reactions during and
following each administration of Venofer.
Venofer should only be administered when staff
trained to evaluate and manage anaphylactic
reactions is immediately available, in an envi­
ronment where full resuscitation facilities can
be assured. The patient should be observed for
adverse effects for at least 30 minutes following
each Venofer administration.
Mode of Administration:
Venofer must only be administered by the intra­
venous route. This may be by drip infusion, slow
injection or directly into the venous line of the
dialysis machine.
Paravenous leakage must be avoided because
leakage of Venofer at the injection site may lead
to pain, inflammation and brown discoloration of
the skin.

xxxxxxx

V_Pf_530_03_GB_Vials_GP_Version_04.indd 1

Vifor (International) Ltd.

If you are breast-feeding, ask your doctor for
advice before you are given Venofer.
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 light-headed
after being given Venofer. If this happens, do not
drive or use any tool or machines. Ask your doc­
tor if you are not sure.

3.  How Venofer is given

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.
Your doctor or nurse will administer Venofer in
one of the following ways:
– Slow injection into your vein – 1 to 3 times per
week.
– As an infusion (drip) into your vein – 1 to 3
times per week.
– During dialysis – it will be put into the venous
line of the dialysis machine.
Venofer will be administered in a structure
where immunoallergic events can receive
appropriate and prompt treatment.
You will be observed for at least 30 minutes by
your doctor or nurse after each administration.
Venofer is a brown liquid and so the injection or
infusion will look brown.
Use in children
Venofer is not recommended for use in children.

4.  Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Intravenous drip infusion:
Venofer must only be diluted in sterile 0.9% m/V
sodium chloride (NaCl) solution. Dilution must
take place immediately prior to infusion and the
solution should be administered as follows:
Venofer
dose
(mg of
iron)

Venofer
dose
(ml of
Venofer)

Maximum
dilution
volume of
sterile
0.9% m/V
NaCl solution

Minimum
Infusion
Time

50 mg
100 mg
200 mg

2.5 ml
5 ml
10 ml

50 ml
100 ml
200 ml

8 minutes
15 minutes
30 minutes

For stability reasons, dilutions to lower Venofer
concentrations are not permissible.
Intravenous injection:
Venofer may be administered by slow intrave­
nous injection at a rate of 1 ml undiluted solution
per minute and not exceeding 10 ml Venofer
(200  mg iron) per injection.
Injection into venous line of dialysis machine:
Venofer may be administered during a haemo­
dialysis session directly into the venous line of
the dialysis machine under the same conditions
as for intravenous injection.
Pf 530-03

08.08.16 15:41

Perforation

The following information is intended
for healthcare professionals only:

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 Venofer is given
to you.

Venofer® CTD-YA539/UK/E01

Allergic reactions (may affect up to 1 in 100 peo­
ple)
If you have an allergic reaction, tell your doctor
or nurse straight away. The signs may include:
• Low blood pressure (feeling dizzy, light-head­
ed or faint).
• Swelling of your face.
• Difficulty breathing.
Tell your doctor or nurse straight away if you
think you are having an allergic reaction.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Changes in your taste such as a metallic
taste. This does not usually last very long.
• Low blood pressure or high blood pressure.
• Feeling sick (nausea).
• Reactions around the site of injection/infu­
sion such as pain, irritation, itching, haema­
toma or discolouration following the leakage
of the injection into the skin.
Uncommon (may affect up to 1 in 100 people)
• Headache or feeling dizzy.
• Stomach pain or diarrhoea.
• Being sick (vomiting).
• Wheezing, difficulty in breathing.
• Itching, rash.
• Muscle spasms, cramps or pain.
• Tingling or “pins and needles”.
• Reduced sensation of touch.
• Vein inflammation.
• Flushing, burning sensation.
• Constipation.
• Joint pain.
• Pain in limbs.
• Back pain.
• Chills.
• Weakness, tiredness.
• Swelling of hands and feet.
• Pain.
• Increased levels of liver enzymes (ALT, AST,
GGT) in the blood.
• Increased serum ferritin levels.
Rare (may affect up to 1 in 1,000 people)
• Fainting.
• Sleepiness or drowsiness.
• Pounding heart beat (palpitations).
• Changes to the colour of your urine.
• Chest pain.
• Increased sweating.
• Fever.
• Increased lactate dehydrogenase in the
blood.

Perforation

Other side effects with unknown frequency
include: feeling less alert, feeling confused; loss
of consciousness; anxiety; trembling or shaking;
swelling of your face, mouth, tongue or throat
which may cause difficulty in breathing; low
pulse rate; fast pulse rate; circulatory collapse;
vein inflammation causing the formation of a
blood clot; acute narrowing of the airways; itch­
ing, hives, rash or skin redness; cold sweat; gen­
eral feeling of illness; pale skin; sudden lifethreatening allergic reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more informa­
tion on the safety of this medicine.

Shelf life and storage
Do not use this medicine after the expiry date
which is stated on the carton after EXP. Do not
store above 25 °C. Do not freeze. Store in the
original package.

5.  How to store Venofer

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label after EXP.
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 immedi­
ately. After dilution with sodium chloride solu­
tion, the diluted solution should be used imme­
diately.
Venofer will normally be stored for you by your
doctor or the hospital.

6.  Contents of the pack and other
information

What Venofer contains
• The active substance is iron (as iron sucrose).
Each millilitre contains 20 mg 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, aque­
ous 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
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tél. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
This leaflet was last revised in 07/2016
For any information about this medicine, please
contact the local representative of the Market­
ing 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

Instruction for use and handling
Ampoules or vials should be visually inspected
for sediment and damage before use. Use only
those containing a sediment free and homoge­
nous solution. The diluted solution must appear
as brown and clear.
Any unused product or waste material should be
disposed of in accordance with local require­
ments.

Shelf life after first opening of the container
From a microbiological point of view, the pro­duct should be used immediately.
Shelf life after dilution with the sterile 0.9% m/V
sodium chloride (NaCl) solution
From a microbiological point of view, the pro­duct should be used immediately after dilution.

xxxxxxx

V_Pf_530_03_GB_Vials_GP_Version_04.indd 2

Vifor (International) Ltd.

Pf 530-03

08.08.16 15:41

Perforation

Incompatibilities
Venofer must not be mixed with other medicinal
products except sterile 0.9% m/V sodium chlo­
ride solution. There is the potential for precipita­
tion and/or interaction if mixed with other solu­
tions or medicinal products. The compatibility
with containers other than glass, polyethylene
and PVC is not known.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL– Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Venofer® CTD-YA539/UK/E01

Package leaflet: Information for the user

Venofer 20 mg iron /ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
medicine is subject to additional
   This
monitoring. This will allow quick identifi­

Other medicines and Venofer
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription, including herbal medi­
cines.

Read all of this leaflet carefully before you
are given this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it
again.
– If you have any further questions, ask your
doctor.
– If you get any side effects, talk to your doctor.
This includes any possible side effects not
listed in this leaflet. See section 4.

This is because Venofer can affect the way
some other medicines work. Also some other
medicines can affect the way Venofer works.

What is in this leaflet
1. What Venofer is and what it is used for
2. What you need to know before Venofer is
given to you
3. How Venofer is given
4. Possible side effects
5. How to store Venofer
6. Contents of the pack and other information

Pregnancy and breast-feeding
Venofer has not been tested in women who are
in the first three months of their pregnancy. It is
important to tell your doctor if you are pregnant,
think you may be pregnant, or are planning to
have a baby.
If you become pregnant during treatment, you
must ask your doctor for advice.
Your doctor will decide whether or not you
should be given this medicine.

cation of new safety information. You can
help by reporting any side effects you may
get. See the end of section 4 for how to
report side effects.

1.  What Venofer is and what it is used
for
Venofer is a medicine that contains iron.

Medicines that contain iron are used when you
do not have enough iron in your body. This is
called “iron deficiency”.
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.  What you need to know before
Venofer is given to you

You must not receive Venofer if:
– You are allergic (hypersensitive) to the prod­
uct or any of the other ingredients of this
medicine (listed in section 6).
– You have experienced serious allergic
(hypersensitive) reactions to other injectable
iron preparations.
– 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 must not be given Venofer if any of the above
apply to you. If you are not sure, talk to your doc­
tor before having Venofer.

Perforation

Warnings and precautions
Talk to your doctor or nurse before receiving
Venofer if:
– You have a history of medicine allergy.
– You have systemic lupus erythematosus.
– You have rheumatoid arthritis.
– You have severe asthma, eczema or other
allergies.
– 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.

Administration
Monitor carefully patients for signs and symp­
toms of hypersensitivity reactions during and
following each administration of Venofer.
Venofer should only be administered when staff
trained to evaluate and manage anaphylactic
reactions is immediately available, in an envi­
ronment where full resuscitation facilities can
be assured. The patient should be observed for
adverse effects for at least 30 minutes following
each Venofer administration.
Mode of Administration:
Venofer must only be administered by the intra­
venous route. This may be by drip infusion, slow
injection or directly into the venous line of the
dialysis machine.
Paravenous leakage must be avoided because
leakage of Venofer at the injection site may lead
to pain, inflammation and brown discoloration of
the skin.



V_Pf_745_01_UK_Vials_GP_Version_04.indd 1

Vifor (International) Ltd.

If you are breast-feeding, ask your doctor for
advice before you are given Venofer.
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 light-headed
after being given Venofer. If this happens, do not
drive or use any tool or machines. Ask your doc­
tor if you are not sure.

3.  How Venofer is given

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.
Your doctor or nurse will administer Venofer in
one of the following ways:
– Slow injection into your vein – 1 to 3 times per
week.
– As an infusion (drip) into your vein – 1 to 3
times per week.
– During dialysis – it will be put into the venous
line of the dialysis machine.
Venofer will be administered in a structure
where immunoallergic events can receive
appropriate and prompt treatment.
You will be observed for at least 30 minutes by
your doctor or nurse after each administration.
Venofer is a brown liquid and so the injection or
infusion will look brown.
Use in children
Venofer is not recommended for use in children.

4.  Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Intravenous drip infusion:
Venofer must only be diluted in sterile 0.9% m/V
sodium chloride (NaCl) solution. Dilution must
take place immediately prior to infusion and the
solution should be administered as follows:
Venofer
dose
(mg of
iron)

Venofer
dose
(ml of
Venofer)

Maximum
dilution
volume of
sterile
0.9% m/V
NaCl solution

Minimum
Infusion
Time

50 mg
100 mg
200 mg

2.5 ml
5 ml
10 ml

50 ml
100 ml
200 ml

8 minutes
15 minutes
30 minutes

For stability reasons, dilutions to lower Venofer
concentrations are not permissible.
Intravenous injection:
Venofer may be administered by slow intrave­
nous injection at a rate of 1 ml undiluted solution
per minute and not exceeding 10 ml Venofer
(200  mg iron) per injection.
Injection into venous line of dialysis machine:
Venofer may be administered during a haemo­
dialysis session directly into the venous line of
the dialysis machine under the same conditions
as for intravenous injection.
Pf 745-01

08.08.16 15:44

Perforation

The following information is intended
for healthcare professionals only:

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 Venofer is given
to you.

Venofer® CTD-YA539/UK/E01

Allergic reactions (may affect up to 1 in 100 peo­
ple)
If you have an allergic reaction, tell your doctor
or nurse straight away. The signs may include:
• Low blood pressure (feeling dizzy, light-head­
ed or faint).
• Swelling of your face.
• Difficulty breathing.
Tell your doctor or nurse straight away if you
think you are having an allergic reaction.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Changes in your taste such as a metallic
taste. This does not usually last very long.
• Low blood pressure or high blood pressure.
• Feeling sick (nausea).
• Reactions around the site of injection/infu­
sion such as pain, irritation, itching, haema­
toma or discolouration following the leakage
of the injection into the skin.
Uncommon (may affect up to 1 in 100 people)
• Headache or feeling dizzy.
• Stomach pain or diarrhoea.
• Being sick (vomiting).
• Wheezing, difficulty in breathing.
• Itching, rash.
• Muscle spasms, cramps or pain.
• Tingling or “pins and needles”.
• Reduced sensation of touch.
• Vein inflammation.
• Flushing, burning sensation.
• Constipation.
• Joint pain.
• Pain in limbs.
• Back pain.
• Chills.
• Weakness, tiredness.
• Swelling of hands and feet.
• Pain.
• Increased levels of liver enzymes (ALT, AST,
GGT) in the blood.
• Increased serum ferritin levels.
Rare (may affect up to 1 in 1,000 people)
• Fainting.
• Sleepiness or drowsiness.
• Pounding heart beat (palpitations).
• Changes to the colour of your urine.
• Chest pain.
• Increased sweating.
• Fever.
• Increased lactate dehydrogenase in the
blood.

Perforation

Other side effects with unknown frequency
include: feeling less alert, feeling confused; loss
of consciousness; anxiety; trembling or shaking;
swelling of your face, mouth, tongue or throat
which may cause difficulty in breathing; low
pulse rate; fast pulse rate; circulatory collapse;
vein inflammation causing the formation of a
blood clot; acute narrowing of the airways; itch­
ing, hives, rash or skin redness; cold sweat; gen­
eral feeling of illness; pale skin; sudden lifethreatening allergic reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or
nurse. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting
side effects you can help provide more informa­
tion on the safety of this medicine.

Shelf life and storage
Do not use this medicine after the expiry date
which is stated on the carton after EXP. Do not
store above 25 °C. Do not freeze. Store in the
original package.

5.  How to store Venofer

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label after EXP.
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 immedi­
ately. After dilution with sodium chloride solu­
tion, the diluted solution should be used imme­
diately.
Venofer will normally be stored for you by your
doctor or the hospital.

6.  Contents of the pack and other
information

What Venofer contains
• The active substance is iron (as iron sucrose).
Each millilitre contains 20 mg 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, aque­
ous 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
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tél. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
This leaflet was last revised in 07/2016
For any information about this medicine, please
contact the local representative of the Market­
ing 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

Instruction for use and handling
Ampoules or vials should be visually inspected
for sediment and damage before use. Use only
those containing a sediment free and homoge­
nous solution. The diluted solution must appear
as brown and clear.
Any unused product or waste material should be
disposed of in accordance with local require­
ments.

Shelf life after first opening of the container
From a microbiological point of view, the pro­duct should be used immediately.
Shelf life after dilution with the sterile 0.9% m/V
sodium chloride (NaCl) solution
From a microbiological point of view, the pro­duct should be used immediately after dilution.



V_Pf_745_01_UK_Vials_GP_Version_04.indd 2

Vifor (International) Ltd.

Pf 745-01

08.08.16 15:44

Perforation

Incompatibilities
Venofer must not be mixed with other medicinal
products except sterile 0.9% m/V sodium chlo­
ride solution. There is the potential for precipita­
tion and/or interaction if mixed with other solu­
tions or medicinal products. The compatibility
with containers other than glass, polyethylene
and PVC is not known.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL– Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Venofer® CTD-YA539/UK/E01

Package leaflet: Information for the user

Venofer 20 mg iron /ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
medicine is subject to addition   alThismonitoring.
This will allow quick
identification of new safety information. You can help by reporting any
side effects you may get. See the
end of section 4 for how to report
side effects.

Read all of this leaflet carefully before
you are given this medicine because
it contains important information for
you.
– Keep this leaflet. You may need to read
it again.
– If you have any further questions, ask
your doctor.
– If you get any side effects, talk to your
doctor. This includes any possible side
effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Venofer is and what it is used for
2. What you need to know before Venofer
is given to you
3. How Venofer is given
4. Possible side effects
5. How to store Venofer
6. Contents of the pack and other information

1.  What Venofer is and what it is
used for

Venofer is a medicine that contains iron.
Medicines that contain iron are used
when you do not have enough iron in your
body. This is called “iron deficiency”.
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.  What you need to know before
Venofer is given to you

You must not receive Venofer if:
– You are allergic (hypersensitive) to the
product or any of the other ingredients
of this medicine (listed in section 6).
– You have experienced serious allergic
(hypersensitive) reactions to other
injectable iron preparations.
– 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 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.

Perforation

Warnings and precautions
Talk to your doctor or nurse before receiving Venofer if:
– You have a history of medicine allergy.
– You have systemic lupus erythematosus.
– You have rheumatoid arthritis.
– You have severe asthma, eczema or
other allergies.
– 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.

Administration
Monitor carefully patients for signs and
symptoms of hypersensitivity reactions
during and following each administration
of Venofer.
Venofer 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 Venofer administration.

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
Venofer is given to you.
Pregnancy and breast-feeding
Venofer has not been tested in women
who are in the first three months of their
pregnancy. It is important to tell your doctor if you are pregnant, think you may be
pregnant, or are planning to have a baby.
If you become pregnant during treatment,
you must ask your doctor for advice.
Your doctor will decide whether or not
you should be given this medicine.
If you are breast-feeding, ask your doctor
for advice before you are given Venofer.
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

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.
Your doctor or nurse will administer
Venofer in one of the following ways:
– Slow injection into your vein – 1 to 3
times per week.
– As an infusion (drip) into your vein –
1 to 3 times per week.
– During dialysis – it will be put into the
venous line of the dialysis machine.
Venofer will be administered in a structure where immunoallergic events can
receive appropriate and prompt treatment.
You will be observed for at least 30 minutes by your doctor or nurse after each
administration.
Venofer is a brown liquid and so the injection or infusion will look brown.
Use in children
Venofer is not recommended for use in
children.

4.  Possible side effects

Like all medicines, this medicine can
cause side effects, although not everybody gets them.

Mode of Administration:
Venofer must only be administered by the
intravenous route. This may be by drip
infusion, slow injection or directly into the
venous line of the dialysis machine.
Paravenous leakage must be avoided
because leakage of Venofer at the injection site may lead to pain, inflammation
and brown discoloration of the skin.
Intravenous drip infusion:
Venofer must only be diluted in sterile
0.9% m/V sodium chloride (NaCl) solution.
Dilution must take place immediately
prior to infusion and the solution should
be administered as follows:

Venofer dose Venofer dose Maximum dilution volume of
(mg of iron) (ml of Venofer) sterile 0.9% m/V NaCl solution
50 mg
100 mg
200 mg

2.5 ml
5 ml
10 ml



V_Pf_UK_Vials_5x5_VIT_Version_01.indd 1

Vifor (International) Ltd.

50 ml
100 ml
200 ml

Minimum
Infusion
Time
8 minutes
15 minutes
30 minutes

Pf UK Vials

08.08.16 07:44

Perforation

The following information is
intended for healthcare
professionals only:

Other medicines and Venofer
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. This includes medicines obtained without a prescription,
including herbal medicines.

Venofer® CTD-YA539/UK/E01

Allergic reactions (may affect up to 1 in
100 people)
If you have an allergic reaction, tell your
doctor or nurse straight away. The signs
may include:
• Low blood pressure (feeling dizzy,
light-headed or faint).
• Swelling of your face.
• Difficulty breathing.
Tell your doctor or nurse straight away if
you think you are having an allergic reaction.
Other side effects include:
Common (may affect up to 1 in 10 people)
• Changes in your taste such as a metallic taste. This does not usually last very
long.
• Low blood pressure or high blood pressure.
• Feeling sick (nausea).
• Reactions around the site of injection/
infusion such as pain, irritation, itching,
haematoma or discolouration following the leakage of the injection into the
skin.
Uncommon (may affect up to 1 in 100
people)
• Headache or feeling dizzy.
• Stomach pain or diarrhoea.
• Being sick (vomiting).
• Wheezing, difficulty in breathing.
• Itching, rash.
• Muscle spasms, cramps or pain.
• Tingling or “pins and needles”.
• Reduced sensation of touch.
• Vein inflammation.
• Flushing, burning sensation.
• Constipation.
• Joint pain.
• Pain in limbs.
• Back pain.
• Chills.
• Weakness, tiredness.
• Swelling of hands and feet.
• Pain.
• Increased levels of liver enzymes (ALT,
AST, GGT) in the blood.
• Increased serum ferritin levels.
Rare (may affect up to 1 in 1,000 people)
• Fainting.
• Sleepiness or drowsiness.
• Pounding heart beat (palpitations).
• Changes to the colour of your urine.
• Chest pain.
• Increased sweating.
• Fever.
• Increased lactate dehydrogenase in
the blood.
Other side effects with unknown frequency include: feeling less alert, feeling confused; loss of consciousness; anxiety;
trembling or shaking; swelling of your
face, mouth, tongue or throat which may
cause difficulty in breathing; low pulse
rate; fast pulse rate; circulatory collapse;
vein inflammation causing the formation
of a blood clot; acute narrowing of the
airways; itching, hives, rash or skin redness; cold sweat; general feeling of illness; pale skin; sudden life-threatening
allergic reactions.

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

5.  How to store Venofer

Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the label after
EXP.
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.  Contents of the pack and other
information

What Venofer contains
• The active substance is iron (as iron
sucrose). Each millilitre contains 20 mg
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
100–101 Terrasse Boieldieu
Tour Franklin La Défense 8
92042 Paris La Défense Cedex
France
Tél. +33 (0)1 41 06 58 90
Fax +33 (0)1 41 06 58 99
This leaflet was last revised in
07/2016.
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

Reporting of side effects
If you get any side effects, talk to your
doctor or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly
(see details below). By reporting side
effects you can help provide more information on the safety of this medicine.

Perforation

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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.
Injection into venous line of dialysis
machine:
Venofer may be administered during a
haemo­dialysis session directly into the
venous line of the dialysis machine under
the same conditions as for intravenous
injection.
Incompatibilities
Venofer must not be mixed with other
medicinal products except sterile 0.9%
m/V sodium chloride solution. There is
the potential for precipitation and/or
interaction if mixed with other solutions
or medicinal products. The compatibility
with containers other than glass, poly­
ethylene and PVC is not known.

xxxxxx

V_Pf_UK_Vials_5x5_VIT_Version_01.indd 2

Vifor (International) Ltd.

Shelf life and storage
Do not use this medicine after the expiry
date which is stated on the carton after
EXP. Do not store above 25 °C. Do not
freeze. Store in the original package.
Shelf life after first opening of the container
From a microbiological point of view, the
product should be used immediately.
Shelf life after dilution with the sterile
0.9% m/V sodium chloride (NaCl) solution
From a microbiological point of view, the
pro­duct should be used immediately after
dilution.
Instruction for use and handling
Ampoules or vials should be visually
inspected for sediment and damage
before use. Use only those containing a
sediment free and homogenous solution.
The diluted solution must appear as
brown and clear.
Any unused product or waste material
should be disposed of in accordance with
local requirements.

Pf UK Vials

08.08.16 07:44

Perforation

For stability reasons, dilutions to lower
Venofer concentrations are not permissible.

Expand Transcript

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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