Last Updated on eMC 29-09-2014 View medicine  | Pharmacosmos UK Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:06-08-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In section 10. Date of revision of the text, corrected to: 2014-08-06 

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC:06-08-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

$0Addition of black trianglewording:$0$0BT_1000x858pxThis medicinal product issubject to additional monitoring. This will allow quick identification of newsafety information. Healthcare professionals are asked to report any suspectedadverse reactions. See section 4.8 for how to report adverse reactions.$0$0$0$0 $0$0In Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION,addition of wording:$0$0One ml of solution contains up to 4.6 mg (0.2 mmol)sodium, see section 4.4.$0$0$0$0$0In Section 3. PHARMACEUTICAL form, change of wording:$0$0From:$0$0Solutionfor injection.$0$0$0$0Dark brown, non transparent solution.$0$0To:$0$0Solutionfor injection.$0$0$0$0Darkbrown, non transparent solution with pH 5.0-7.0 and an approximate osmolarityof 400 mOsm/l.$0$0$0$0$0In Section 4.1 Therapeutic indications, change ofwording:$0$0From:$0$0Diaferis indicated in adults for the treatment of iron deficiency in patients withchronic kidney disease on dialysis.$0$0$0$0Thediagnosis of iron deficiency should be based on appropriate laboratory tests(e.g. serum ferritin, serum iron, transferrin saturation or hypochromic redcells).$0$0$0$0To:$0$0Diaferis indicated in adults for the treatment of iron deficiency in patients withchronic kidney disease on dialysis, when oral iron preparations are ineffectiveor cannot be used.$0$0$0$0Thediagnosis of iron deficiency should be based on appropriate laboratory tests(e.g. serum ferritin, serum iron, transferrin saturation or hypochromic redcells).$0$0$0$0$0$0In Section 4.2 Posology and method of administration -Method of administration, $0$0change of wording:$0$0From:$0$0Method ofadministration:$0$0Anaphylactoidreactions to parenteral iron are usually evident within a few minutes, andclose observation is necessary to ensure recognition. If at any time during theintravenous administration of Diafer, any signs of a hypersensitivity reactionor intolerance are detected, administration must be stopped immediately.$0$0$0$0Resuscitativemedication and personnel trained to evaluate and handle anaphylactoid reactionsshould be available whenever a dose of parenteral iron is administered.$0$0To:$0$0Method ofadministration:$0$0Monitorcarefully patients for signs and symptoms of hypersensitivity reactions duringand following each administration of Diafer.$0$0$0$0Diafershould only be administered when staff trained to evaluate and manage anaphylacticreactions is immediately available, in an environment where full resuscitationfacilities can be assured. The patient should be observed for adverse effectsfor at least 30 minutes following each Diafer injection (see section 4.4).$0$0$0$0$0$0$0In Section 4.3 Contraindications, change of wording:$0$0From:$0$0$0$0·Non-irondeficiency anaemia (e.g. haemolytic anaemia)$0$0·Ironoverload or disturbances in utilisation of iron (e.g. haemochromatosis,haemosiderosis)$0$0·Hypersensitivityto the active substance or to any of the excipients listed in section 6.1$0$0·Patientswith a history of asthma, allergic eczema or other atopic allergy$0$0·Decompensatedliver cirrhosis and hepatitis$0$0·Rheumatoidarthritis with symptoms or signs of active inflammation$0$0To:$0$0·Non-irondeficiency anaemia (e.g. haemolytic anaemia)$0$0·Ironoverload or disturbances in utilisation of iron (e.g. haemochromatosis,haemosiderosis)$0$0·Hypersensitivityto the active substance, to Diafer  orany of its excipients listed in section 6.1$0$0·Knownserious hypersensitivity to other parenteral iron products$0$0·Decompensatedliver cirrhosis and hepatitis$0$0 $0$0In Section 4.4 Special warningsand precautions for use, change to wording:$0$0From:$0$0Parenteraladministration of all iron complexes may cause immediate severe and potentiallylethal hypersensitivity reactions. The risk is enhanced for patients with known(medical) allergies. Resuscitative$0$0medication and personnel trained to evaluateand handle anaphylactoid reactions should therefore be available. There isparticularly increased risk of allergic reactions to parenteral iron complexesin$0$0patients with immune or inflammatory conditions (e.g. systemic lupuserythematosus, rheumathoid arthritis).$0$0$0$0Parenteraliron should be used with caution in case of acute or chronic infection.$0$0$0$0Diafershould not be used in patients with ongoing bacteraemia.$0$0$0$0Hypotensiveepisodes may occur if intravenous injection is administered too rapidly.$0$0$0$0To:$0$0Parenterallyadministered iron preparations can cause hypersensitivity reactions includingserious and potentially fatal anaphylactic/anaphylactoid reactions.Hypersensitivity reactions have also been reported after previously uneventfuldoses of parenteral iron complexes.$0$0$0$0Therisk is enhanced for patients with known allergies including drug allergies,including patients with a history of severe asthma, eczema or other atopicallergy.$0$0$0$0Thereis also an increased risk of hypersensitivity reactions to parenteral iron complexesin patients with immune or inflammatory conditions (e.g. systemic lupuserythematosus, rheumatoid arthritis). $0$0Diafershould only be administered when staff trained to evaluate and manageanaphylactic reactions is immediately available, in an environment where fullresuscitation facilities can be assured. Each patient should be observed foradverse effects for at least 30 minutes following each Diafer injection. Ifhypersensitivity reactions or signs of intolerance occur during administration,the treatment must be stopped immediately. Facilities for cardio respiratoryresuscitation and equipment for handling acute anaphylactic/anaphylactoidreactions should be available, including an injectable 1:1000 adrenalinesolution. Additional treatment with antihistamines and/or corticosteroidsshould be given as appropriate.$0$0$0$0Parenteraliron should be used with caution in case of acute or chronic infection.$0$0$0$0Diafershould not be used in patients with ongoing bacteraemia.$0$0$0$0Hypotensiveepisodes may occur if intravenous injection is administered too rapidly.$0$0$0$0One mlof undiluted Diafer contains up to 4.6 mg (0.2 mmol) of sodium. This has to betaken into account in patients on a sodium-controlled diet.$0$0$0$0 $0$0In Section 4.6 Fertility,pregnancy and lactation, change of wording:$0$0From:$0$0Pregnancy$0$0Thereare no adequate and well-controlled trials of Diafer in pregnant women. Acareful risk/benefit evaluation is therefore required before use duringpregnancy and Diafer should not be used during pregnancy unless clearlynecessary.$0$0Irondeficiency anaemia occurring in the first trimester of pregnancy can in manycases be treated with oral iron. If the benefit of Diafer treatment is judgedto outweigh the potential risk to the foetus, the treatment should be confinedto second and third trimester.$0$0Breast-feeding$0$0Thereis no information available on the excretion of Diafer in the human breastmilk.$0$0Fertility$0$0Thereis no information available on the possible effects of Diafer on male andfemale fertility.$0$0To:$0$0Pregnancy$0$0Thereare no adequate and well-controlled trials of Diafer in pregnant women. Acareful risk/benefit evaluation is therefore required before use during pregnancyand Diafer should not be used during pregnancy unless clearly necessary (seesection 4.4).$0$0Irondeficiency anaemia occurring in the first trimester of pregnancy can in manycases be treated with oral iron. Treatment with Diafer should be confined tothe second and third trimester if the benefit is judged to outweigh thepotential risk for both the mother and the foetus.$0$0$0$0Breastfeeding$0$0Thereis no information available on the excretion of Diafer in the human breastmilk.$0$0Fertility$0$0Thereis no information available on the possible effects of Diafer on male andfemale fertility.$0$0 $0$0In Section 4.8 Undesirable effects, addition of wording:$0$0Reporting of suspectedadverse reactions$0$0Reportingsuspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of themedicinal product. Healthcare professionals are asked to report any suspectedadverse reactions via $0$0Yellow Card Scheme$0$0Website: www.mhra.gov.uk/yellowcard$0$0 $0$0In Section 5.2Pharmacokinetic properties, addition of wording:$0$0Pharmacokineticstudies are not available for Diafer. Information given is based on literaturedata from various parenteral iron preparations.$0$0$0$0 $0$0In Section 5.3 Preclinical safety data, addition of wording:$0$0 $0$0Pharmacokineticstudies are not available for Diafer. Information given is based on literaturedata from various parenteral iron preparations. $0$0 $0$0In Section 6.3 Shelflife, change to wording:$0$0From:$0$0$0$030months$0$0$0$0Shelf life after first opening of the container (undiluted):$0$0From amicrobiological point of view, unless the method of opening precludes the riskof microbial contamination, the product should be used immediately.$0$0$0$0If notused immediately, in-use storage times and conditions are the responsibility ofthe user.$0$0$0$0Shelf life after dilution with sterile 0.9% sodium chloride:$0$0Chemicaland physical in-use stability has been demonstrated for 48 hours at 30°C in dilutions with up to20 ml sterile 0.9% sodium chloride.$0$0$0$0From amicrobiological point of view, the product should be used immediately. If notused immediately, in-use storage times and conditions prior to use are theresponsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has takenplace in controlled and validated aseptic conditions.$0$0$0$0 $0$0To:$0$030months$0$0$0$0Shelf life after first opening of the container (undiluted):$0$0From amicrobiological point of view the product should be used immediately.$0$0$0$0Shelf life after dilution with sterile 0.9% sodium chloride:$0$0Chemicaland physical in-use stability has been demonstrated for 48 hours at 30°C in dilutions with up to20 ml sterile 0.9% sodium chloride.$0$0$0$0From a microbiological point of view, unless the method of opening/reconstitution/ dilution precludes the risk of microbial contamination, theproduct should be used immediately.$0$0If not used immediately, in-use storage times andconditions are the responsibility of user.$0$0 $0$0InSection 6.6 Special precautions for disposal, change to section header:$0$0From$0$06.6     Special precautions for disposal <and other handling>$0$0$0$0To:$0$06.6     Special precautions for disposal and other handling$0$0 $0$0In Section 9. DATE OF FIRST AUTHORISATION / RENEWAL OF THEAUTHORISATION, change of $0$0wording:$0$0Date offirst authorisation: 26/03/2013$0$0$0$0 $0$0In Section 10. DATEOF REVISION OF THE TEXT, change to date:$0$0$0$02014-02 $0

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties

Date of revision of text on the SPC:14-02-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1, Correction - text from section 5.2 had previously been entered in error.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO