Venofer (iron sucrose)

  • Name:

    Venofer (iron sucrose)

  • Company:
    info
  • Active Ingredients:

    Iron Sucrose

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/02/20

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Summary of Product Characteristics last updated on medicines.ie: 3/2/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Vifor Pharma UK Limited

Vifor Pharma UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Ferinject (ferric carboxymaltose) Active Ingredients Ferric carboxymaltose
Medicine Name Velphoro 500 mg chewable tablets Active Ingredients Sucroferric oxyhydroxide
Medicine Name Venofer (iron sucrose) Active Ingredients Iron Sucrose
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 3 February 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Sections 4.4 Special warnings and precautions for use and 4.8 undesirable effects table have been updated to include additional wording regarding Kournis syndrome and is highlighted in the blue text below.

 

4.4.       Special warnings and precautions for use

 

 Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8). In several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Venofer was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see section 4.3.

 

  

4.8.       Undesirable effects

 

Cardiac disorders (frequency unknown) - Bradycardia, tachycardia, Kounis syndrome

 

 

Updated on 3 February 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 Special warnings and precautions for use and 4.8 undesirable effects table have been updated to include additional wording regarding Kournis syndrome and is highlighted in the blue text below.

4.4.       Special warnings and precautions for use

 

 Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8). In several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Venofer was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see section 4.3.

 

  

4.8.       Undesirable effects

 Cardiac disorders (frequency unknown) - Bradycardia, tachycardia, Kounis syndrome

 

Updated on 3 February 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

 Sections 4.4 Special warnings and precautions for use and 4.8 undesirable effects table have been updated to include additional wording regarding Kournis syndrome and is highlighted in the blue text below.

4.4.       Special warnings and precautions for use

 

 

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. There have been reports of hypersensitivity reactions which progressed to Kounis syndrome (acute allergic coronary arteriospasm that can result in myocardial infarction, see section 4.8). In several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Venofer was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see section 4.3.

 

4.8.       Undesirable effects

Cardiac disorders (frequency unknown) - Bradycardia, tachycardia, Kounis syndrome

Updated on 19 November 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.6 Fertility, pregnancy and lactation has been updated to include additional wording regarding foetal bradycardia and is highlighted in the blue text below.

Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.

Updated on 17 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 14 May 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 3 May 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of ADR influenza like illness and amendment of anaphylactoid reactions to anaphylactoid/anaphylactic reactions.

Anaphylactoid/anaphylactic reactions were reported only in the post-marketing setting (estimated as rare); fatalities have been reported. See section 4.4.

 

Updated on 30 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4.2       Posology and method of administration

The patient should be observed for adverse effects for at least 30 minutes following each Venofer administration

 

4.4       Special warnings and precautions for use

Paravenous leakage must be avoided because leakage of Venofer at the injection site can lead to pain, inflammation and brown discoloration of the skin

 

4.8       Undesirable effects

Changes to the frequency and  terminology around certain adverse events

 

10                    Date of Revision of the Text

August 2016

Updated on 30 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 August 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 August 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 19 July 2016 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$07. MARKETING AUTHORISATION HOLDER$0$0$0$0$0Has changed from$0$0$0$0$0Vifor France SA$0$07-13, Boulevard Paul-Emile Victor$0$092200 Neuilly-sur-Seine$0$0France$0$0Tel. +33 (0)1 41 06 58 90$0$0Fax +33 (0)1 41 06 58 99 $0$0$0$0$0To$0$0$0$0$0Vifor France $0$0100-101 Terrasse Boieldieu $0$0Tour Franklin La Défense 8$0$092042 Paris La Défense Cedex$0$0France$0$0Tel.  +33 (0)1 41 06 58 90$0$0Fax  +33 (0)1 41 06 58 99$0$0$0$0$010. DATE OF REVISION OF THE TEXT$0$0$0$0

Updated on 19 July 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 14 June 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4   Clinical Particulars

4.1  Therapeutic Indications

in chronic kidney disease when oral iron preparations are less effective.

has been changed to

in chronic kidney disease when oral iron preparations are less effective than venofer.

10 Date of Revision of the Text

Is now April 2016

Updated on 18 March 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



4.6 Fertility, pregnancy and lactation

Fertility

No effects of iron sucrose treatment were observed on fertility and mating performance in rats.

10 DATE OF REVISION OF THE TEXT

February 2016

Updated on 23 October 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$04.1 Therapeutic Indications$0$0• Where there is a clinical need for a rapid iron supply (wording change)$0$0• In chronic kidney disease when oral iron preparations are less effective than Venofer (addition)$0$0$0$0$0The diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. Hb, serum ferritin, TSAT, serum iron, etc.).$0$0(Hb haemoglobin, TSAT transferrin saturation)$0$0(clarification)$0$0$0$0$0$0$0$04.2 Posology and method of administration$0$0Clarrification in the dosing table$0$0$0$0$04.3 Contraindications$0$0• Anaemia not caused by iron deficiency (wording change)$0$0$0$0$05.1 Pharmacodynamic properties$0$0$0$0$0(Addition:)$0$0$0$0$0Pharmacotherapeutic group: Anti-anaemic preparation, iron, parenteral preparation, ATC code: B03AC$0$0$0$0$0Mechanism of action$0$0$0$0$0Iron sucrose, the active ingredient of Venofer, is composed of a polynuclear iron(III)-hydroxide core surrounded by a large number of non-covalently bound sucrose molecules. The complex has a weight average molecular weight (Mw) of approximately 43 kDa. The polynuclear iron core has a structure similar to that of the core of the physiological iron storage protein ferritin. The complex is designed to provide, in a controlled manner, utilisable iron for the iron transport and storage proteins in the body (i.e., transferrin and ferritin, respectively).$0$0Following intravenous administration, the polynuclear iron core from the complex is taken up predominantly by the reticuloendothelial system in the liver, spleen, and bone marrow. In a second step, the iron is used for the synthesis of Hb, myoglobin and other iron-containing enzymes, or stored primarily in the liver in the form of ferritin.$0$0$0$0$0Clinical efficacy and safety$0$0$0$0$0Chronic kidney disease$0$0Study LU98001 was a single arm study to investigate the efficacy and safety of 100 mg iron as Venofer for up to 10 sessions over 3–4 weeks in haemodialysis patients with iron deficiency anaemia (Hb >8 and <11.0 g/dl, TSAT <20%, and serum ferritin ≤300 μg/l) who were receiving rHuEPO therapy. A Hb ≥11 g/dl was attained in 60/77 patients. The mean increase in serum ferritin and TSAT was significant from baseline to the end of treatment (Day 24) as well as to the 2 and 5 weeks follow-up visit.$0$0$0$0$0Study 1VEN03027 was a randomised study comparing Venofer (1000 mg in divided doses over 14 days) and oral ferrous sulphate (325 mg 3 times daily for 56 days) in non-dialysis dependent chronic kidney disease patients (Hb ≤11.0 g/dl, serum ferritin ≤300 μg/l, and TSAT ≤25%) with or without rHuEPO. A clinical response (defined as Hb increase ≥1.0 g/dl and serum ferritin increase ≥160 μg/l) was more frequently observed in patients treated with Venofer (31/79; 39.2%) compared to oral iron (1/82; 1.2%); p<0.0001.$0$0$0$0$0Inflammatory Bowel Disease$0$0A randomised, controlled study compared Venofer (single IV dose of 200 mg iron once per week or every second week until the cumulative dose was reached) with oral iron (200 mg twice daily for 20 weeks) in patients with inflammatory bowel disease and anaemia (Hb <11.5 g/dl). At the end of treatment, 66% of patients in the Venofer group had an increase in Hb ≥2.0 g/dl compared to 47% in the oral iron group (p=0.07).$0$0$0$0$0Postpartum$0$0A randomised, controlled trial in women with postpartum iron deficiency anaemia (Hb <9 g/dl and serum ferritin <15 μg/l at 24–48 hours post-delivery) compared 2 × 200 mg iron given as Venofer on Days 2 and 4 (n=22) and 200 mg of oral iron given as ferrous sulphate twice daily for 6 weeks (n=21). The mean increase in Hb from baseline to Day 5 was 2.5 g/dl in the Venofer group and 0.7 g/dl in the oral iron group (p<0.01).$0$0$0$0$0Pregnancy$0$0In a randomised, controlled study, women in their third trimester of pregnancy with iron deficiency anaemia (Hb 8 to 10.5 g/dl and serum ferritin <13 µg/l) were randomised to Venofer (individually calculated total dose of iron administered over 5 days) or oral iron polymaltose complex (100 mg 3× daily until delivery). The increase in Hb from baseline was significantly greater in the Venofer group compared to the oral iron group at Day 28 and at delivery (p<0.01).$0$0$0$0$0$0$0$05.2 Pharmacokinetic properties$0$0(Addition:)$0$0Distribution$0$0$0$0$0The ferrokinetics of iron sucrose labelled with 52Fe and 59Fe were assessed in 6 patients with anaemia and chronic renal failure. In the first 6–8 hours, 52Fe was taken up by the liver, spleen and bone marrow. The radioactive uptake by the macrophage-rich spleen is considered to be representative of the reticuloendothelial iron uptake.$0$0$0$0$0Following intravenous injection of a single 100 mg iron dose of iron sucrose in healthy volunteers, maximum total serum iron concentrations were attained 10 minutes after injection and had an average concentration of 538 µmol/l. The volume of distribution of the central compartment corresponded well to the volume of plasma (approximately 3 litres).$0$0$0$0$0Biotransformation$0$0$0$0$0Upon injection, sucrose largely dissociates and the polynuclear iron core is mainly taken up by the reticuloendothelial system of the liver, spleen, and bone marrow. At 4 weeks after administration, red cell iron utilization ranged from 59 to 97%.$0$0$0$0$0Elimination$0$0$0$0$0The iron sucrose complex has a weight average molecular weight (Mw) of approximately 43 kDa, which is sufficiently large to prevent renal elimination. Renal elimination of iron, occurring in the first 4 hours after injection of a Venofer dose of 100 mg iron, corresponded to less than 5% of the dose. After 24 hours, the total serum iron concentration was reduced to the pre-dose level.Renal elimination of sucrose was about 75% of the administered dose.$0$0$0$0$010 DATE OF REVISION OF THE TEXT$0$0$0$0$0October 2015$0

Updated on 3 September 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Typographical change in section 4.2 Posology and method of administration:

BW

Total amount of Venofer (20 mg iron per ml) to be administered

Hb 6.0 g/dl

Hb 7.5 g/dl

Hb 9.0 g/dl

Hb 10.5 g/dl

Updated on 5 August 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.2

Section has been revised for clarrification

In section 4.3

Typographical changes

In section 4.4

The following text has been incorporated:

 Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes including iron sucrose. However, in several studies performed in patients who had a history of a hypersensitivity reaction to iron dextran or ferric gluconate, Venofer was shown to be well tolerated. For known serious hypersensitivity to other parenteral iron product see section 4.3.

The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.

Parenteral iron should be used with caution in the case of acute or chronic infection. It is recommended that the administration of Venofer is stopped in patients with bacteraemia. In patients with chronic infection, a risk/benefit evaluation should be performed

Paravenous leakage must be avoided because leakage of Venofer at the injection site can lead to pain, inflammation, tissue necrosis and brown discoloration of the skin

In section 4.6

The following text has been incorporated:

There is no data from the use of iron sucrose in pregnant women in the first trimester. Data (303 pregnancy outcomes) from the use of Venofer in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn.

A careful risk/benefit evaluation is required before use during pregnancy and Venofer should not be used during pregnancy unless clearly necessary (see section 4.4).

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Breast-feeding

There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. In one clinical study, 10 healthy breast-feeding mothers with iron deficiency received 100 mg iron in the form of iron sucrose. Four days after treatment, the iron content of the breast milk had not increased and there was no difference from the control group (n=5). It cannot be excluded that newborns/infants may be exposed to iron derived from Venofer via the mother’s milk, therefore the risk/benefit should be assessed

Preclinical data do not indicate direct or indirect harmful effects to the nursing child. In lactating rats treated with 59Fe-labelled iron sucrose, low secretion of iron into the milk and transfer of iron into the offspring was observed. Non metabolised iron sucrose is unlikely to pass into the mother’s milk.

In section 4.8

The following text has been incorporated:

The most commonly reported adverse drug reaction in clinical trials with Venofer was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with Venofer are hypersensitivity reactions, which occurred with a rate of 0.25 events per 100 subjects in clinical trials.

The adverse drug reactions reported after the administration of Venofer in 4,046 subjects in clinical trials as well as those reported from the post-marketing setting are presented in the table below.

Hypertension and hypophosphataemia are now listed as “common”

Dysgeusia, tachycardia, dyspnoea, abdominal pain, constipation, diahorrea, , erythema, rash, muscle spasms and chills are now “uncommon”

Anaphylactoid reactions, loss of consciousness, anxiety, syncope, presyncope, bronchospasm, flatulence, angioedema, pallor, and face oedema, rigors, malaise are now “rare”.

Detail on how to report Adverse events have also been included.

In section 4.9

Overdose can cause iron overload which may manifest itself as haemosiderosis. Overdose should be treated, as deemed necessary by the treating physician, with an iron chelating agent or according to standard medical practice.

In section 5.1

Data has been added on clinical efficacy and safety on Ferinject in in different therapeutic areas necessitating intravenous iron to correct iron deficiency.

In section 5.2

The acronym for Positron emission tomography has been removed

An acronym for iron deficiency has been added.

In section 5.3

 Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity and toxicity to reproduction and development

In section 6.1

Sodium hydroxide (for pH adjustment)

In section 6.2

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 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.

In section 6.4

Do not store above 25°C. Do not freeze. Store in the original package.

For storage conditions after dilution or first opening of the medicinal product, see section 6.3.

In section 6.6

Vials should be visually inspected for sediment and damage before use. Use only those containing a sediment free and homogenous solution.

Venofer must not be mixed with other medicinal products except sterile 0.9% m/V sodium chloride solution for dilution. For instructions on dilution of the product before administration, see section 4.2.

The diluted solution must appear as brown and clear.

Each vial of Venofer is intended for single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

In section 10

Dates of revision has been updated

Updated on 31 July 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 March 2014 SmPC

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 8
 

Marketing Authorisation Number(s) has been updated from "PA 949/1/1" to “PA0949/001/001”


In section 10

 

Date of Revision of Text has been updated from “09/2013” to “March 2014”

 

Updated on 13 November 2013 SmPC

Reasons for updating

  • Addition of black triangle
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.2

 

The following wording has now been included

 

“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 (see section 4.4).”

 

All references to the test dose have been removed.

 

In section 4.3

 

“hypersensitivity to the active substance, to Venofer or any of its excipients listed in section 6.1.” has replaced “known hypersensitivity to Venofer or to any of its excipients”

 

“known serious hypersensitivity to other parenteral iron products.” Has been added

 

The following contraindications have been removed:

• patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions

• pregnancy first trimester.

 


In section 4.4

 

The following text has been incorporated:

 

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.

 

The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.

There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).

 

Ferinject should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available, in an environment where full resuscitation facilities can be assured. Each patient should be observed for adverse effects for at least 30 minutes following each Ferinject injection. If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately. Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.


In section 4.6

 

The following text has been incorporated:

 

“There are no adequate and well-controlled trials of Venofer in pregnant women. A careful risk/benefit evaluation is therefore required before use during pregnancy and Venofer should not be used during pregnancy unless clearly necessary (see section 4.4).

 

Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Venofer should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.

 

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Data on a limited number of exposed human pregnancies indicated no adverse effects of Venofer on pregnancy or on the health of the foetus/newborn child.”

 

The following test has been removed:

 

Data on a limited number of exposed pregnancies indicated no adverse effects of Venofer on pregnancy or on the health of the foetus/newborn child. No well-controlled studies in pregnant women are available to date. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

 

Nevertheless, risk/benefit evaluation is required.

 

Venofer should only be used in pregnant women in whom oral iron is ineffective or cannot be tolerated and the level of anaemia is judged sufficient to put the mother or foetus at risk.

 

In section 4.8

 

The following text has been incorporated:

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

 

In section 10

 

Dates of revision has been updated

Updated on 11 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Addition of black triangle

Updated on 1 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of black triangle

Updated on 3 October 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 September 2011 PIL

Reasons for updating

  • New PIL for medicines.ie