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

Active substance: IRON SUCROSE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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.

1.   HAT VENOFER IS AND WHAT IT IS
W
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.   HAT YOU NEED TO KNOW BEFORE
W
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 injection.
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, tissue necrosis and brown
discoloration of the skin.

F.1/xxxxxxx

V_Pf_431_02_GB_Takeda_Version_02.indd 1

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 431-02

19.02.15 11:21

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.



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.

Allergic reactions (may affect up to 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, 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.

Perforation

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).
• Pain around the site of injection.
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 cramps or muscle pain.
• Reactions around the site of injection such
as a feeling of burning, irritation or discolouration, or pain following the leakage of the
injection into the skin.
• Abnormally high concentration of red blood
cells in the blood.
• Burning sensation.
• Tingling or “pins and needles”.
• Reduced sensation of touch.
• Vein inflammation.
• Changes to the colour of your urine.
• Constipation.
• Joint pain.
• Extremity pain.
• Back pain.
• Chills.
• Weakness, tiredness.
• Pain.
• Increased levels of liver enzymes (GGT, ALT,
AST) in the blood.
• Abnormal liver function tests.
Rare (may affect up to 1 in 1,000 people)
• Fainting.
• Feeling hot.
• Lung infection.
• Migraine headache.
• Sleepiness or drowsiness.
• Pounding heart beat (palpitations).
• Flushing.
• Dry mouth.
• Discomfort in extremities.
• Muscle spasms.
• Chest pain.
• Fever.
• Itching or bruising at the injection site.
• Increased serum ferritin levels (possibly due
to iron overload).
• Increased lactate dehydrogenase and/or
creatinine in the blood.

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.
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

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 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

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;
increased sweating; low pulse rate; fast pulse
rate; circulatory collapse; blood clots in veins;
acute narrowing of the airways; itching, hives,
rash or skin redness; decreased muscle tone;
cold sweat; general feeling of illness; pale skin;
sudden life-threatening allergic reactions; vein
inflammation causing the formation of a blood
clot.

This leaflet was last revised in 02/2015.

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.

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.

Vifor Pharma UK Limited
The Old Stables, Bagshot Park
Bagshot
Surrey
GU19 5PJ
United Kingdom
Tel: +44 1276 853600
Fax : +44 1276 452341

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

Pf 431-02

19.02.15 11:21

Perforation

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.

For any information about this medicine, please
contact the local representative of the Marketing Authorisation Holder.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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.   HAT VENOFER IS AND WHAT IT IS
W
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.   HAT YOU NEED TO KNOW BEFORE
W
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.
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 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.

Perforation

If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before you
are given Venofer.

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.

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 injection.
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, tissue necrosis 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
(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.

xxxxxxxx

Pf 530-02

Perforation

The following information is intended
for healthcare professionals only:

Allergic reactions (may affect up to 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, 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.

Perforation

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).
• Pain around the site of injection.
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 cramps or muscle pain.
• Reactions around the site of injection such as
a feeling of burning, irritation or discolouration, or pain following the leakage of the
injection into the skin.
• Abnormally high concentration of red blood
cells in the blood.
• Burning sensation.
• Tingling or “pins and needles”.
• Reduced sensation of touch.
• Vein inflammation.
• Changes to the colour of your urine.
• Constipation.
• Joint pain.
• Extremity pain.
• Back pain.
• Chills.
• Weakness, tiredness.
• Pain.
• Increased levels of liver enzymes (GGT, ALT,
AST) in the blood.
• Abnormal liver function tests.
Rare (may affect up to 1 in 1,000 people)
• Fainting.
• Feeling hot.
• Lung infection.
• Migraine headache.
• Sleepiness or drowsiness.
• Pounding heart beat (palpitations).
• Flushing.
• Dry mouth.
• Discomfort in extremities.
• Muscle spasms.
• Chest pain.
• Fever.
• Itching or bruising at the injection site.
• Increased serum ferritin levels (possibly due
to iron overload).
• Increased lactate dehydrogenase and/or
creatinine in the blood.

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.
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

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 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

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;
increased sweating; low pulse rate; fast pulse
rate; circulatory collapse; blood clots in veins;
acute narrowing of the airways; itching, hives,
rash or skin redness; decreased muscle tone;
cold sweat; general feeling of illness; pale skin;
sudden life-threatening allergic reactions; vein
inflammation causing the formation of a blood
clot.

This leaflet was last revised in 02/2015.

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.

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.

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.

Shelf life after first opening of the container
From a microbiological point of view, the product should be used immediately.

xxxxxxxx

Vifor Pharma UK Limited
The Old Stables, Bagshot Park
Bagshot
Surrey
GU19 5PJ
United Kingdom
Tel: +44 1276 853600
Fax : +44 1276 452341

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 530-02

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.

For any information about this medicine, please
contact the local representative of the Marketing Authorisation Holder.

Expand view ⇕

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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