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
subject additional
   This medicine is will allowtoquick idenmonitoring. This

tification 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.
• 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

1.   HAT VENOFER IS AND WHAT IT
W
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.   EFORE VENOFER IS GIVEN TO
B
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.

Perforation

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 not sure if any of the above apply
to you, talk to your doctor or pharmacist
before you are given Venofer.
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
Venofer is given to you. When you have
finished treatment with Venofer, wait 5
days before taking iron by mouth.
Pregnancy and breast-feeding
Venofer has not been tested in pregnant
women. 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 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.
How Venofer is given
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 limb of the dialyser.
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.
site may lead to pain, inflammation, tissue
necrosis and brown discoloration of the
skin.

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

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 solution
• 5 ml Venofer (100 mg iron) in max. 100 ml
sterile 0.9% m/V sodium chloride solution
• 10 ml Venofer (200 mg iron) in max. 200  ml
sterile 0.9% m/V sodium chloride solution

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.
Paravenous leakage must be avoided
because leakage of Venofer at the injection

F.1/3000307

Pf_431_01_V06__148x420.indd 1

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

Pf 431-01

27.01.14 13:17

Perforation

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

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.

LD-Pf431-01
Min. Fontsize: 10 pt
Version 06
Dimensions: 148 x 420 mm
UK/Irland / Takeda
Art.-Nrn. 625600/625457/625243

PACKAGE LEAFLET: INFORMATION FOR THE USER

ampoules 5ml, vials 5ml,
vials 2.5ml
pl
Manufacturer Takeda

Venofer is a brown liquid and so the injection or infusion will look brown.
Children
Venofer is not recommended for use in children.

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 reaction.
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 (vomiting).
• 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 burning and swelling.
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.

Perforation

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;
c
­ hanges to the colour of your urine.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

5.  HOW TO STORE VENOFER

Keep out of the reach and sight of children.
Do not use Venofer after the expiry date
which is stated on the label.
°C.
Do not store above 25  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
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
This leaflet was last revised in 09/2013.
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

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.

From a microbiological point of view, the
product should be used immediately after
first opening or immediately after dilution
with sterile 0.9% m/V sodium chloride.

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.
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
precipitation and/or interaction. The compatibility with containers other than glass,
polyethylene and PVC is not known.

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.

Stability
The product must not be used after the
expiry date which is stated on the label and
on the outer carton.

F.1/3000307

Pf_431_01_V06__148x420.indd 2

Pf 431-01

27.01.14 13:17

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.

Venofer 20 mg iron /ml
Solution for injection or concentrate for solution for infusion
Iron Sucrose
subject additional
   This medicine is will allowtoquick idenmonitoring. This

tification 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.
• 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

1.   HAT VENOFER IS AND WHAT IT
W
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.   EFORE VENOFER IS GIVEN TO
B
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.

Perforation

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.

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 as a
slow intravenous injection or as an intravenous drip infusion. Venofer must not be
used for intramuscular injection.
81923558

Pf_530_01_V04__148x420.indd 1

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
Venofer is given to you. When you have
finished treatment with Venofer, wait 5
days before taking iron by mouth.
Pregnancy and breast-feeding
Venofer has not been tested in pregnant
women. 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 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.
How Venofer is given
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 limb of the dialyser.
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.

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 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 solution
• 5 ml Venofer (100 mg iron) in max. 100 ml
sterile 0.9% m/V sodium chloride solution
• 10 ml Venofer (200 mg iron) in max. 200  ml
sterile 0.9% m/V sodium chloride solution
For stability reasons, dilutions to lower
Venofer concentrations are not permissible.
Dilution must take place immediately prior
to infusion and the solution should be
administered as follows:

Pf 530-01

14.10.13 11:11

Perforation

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

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

LD-Pf530-01 Min. Fontsize: 10 pt
Version 04
Dimensions: 148 x 420 mm
UK/Irland / GP
Art.-Nr. 625702

PACKAGE LEAFLET: INFORMATION FOR THE USER

vial 2.5ml and vial 5ml
pI
Manufacturer GP Grenzach

Venofer is a brown liquid and so the injection or infusion will look brown.
Children
Venofer is not recommended for use in children.

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 reaction.
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
p
­ eople)
• 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 (vomiting).
• 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 burning and swelling.
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.

Perforation

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;
c
­ hanges to the colour of your urine.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

5.  HOW TO STORE VENOFER

Keep out of the reach and sight of children.
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
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
This leaflet was last revised in 09/2013.
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

• 100 mg iron (5 ml Venofer) over at least 15
minutes
• 200 mg iron (10 ml Venofer) over at least
30 minutes

patibility with containers other than glass,
polyethylene and PVC is not known.

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 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.
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
precipitation and/or interaction. The com81923558

Pf_530_01_V04__148x420.indd 2

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 immediately 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 530-01

14.10.13 11:11

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.

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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