Last Updated on eMC 14-03-2014 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 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text
  • Addition of black triangle

Date of revision of text on the SPC:27-02-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

$0$0$0Addition of black triangle:$0$0'▼This medicinal product is subject toadditional monitoring. This will allow quick identification of new safetyinformation. Healthcare professionals are asked to report any suspected adversereactions. See section 4.8 for how to report adverse reactions.'$0$0$0$0$0In Section 2. QUALITATIVE AND QUANTITATIVE COMPOSITION, change of wording:$0$0From:$0$0'For a full list of excipients, see 6.1.'$0$0To:$0$0'Forthe full list of excipients, see section 6.1.'$0$0$0$0In Section 4.2.  Posologyand method of administration:$0$0$0$0Removal of test dose.$0$0$0$0$0Replaced with:$0$0'Monitor carefully patients for signs and symptoms of hypersensitivityreactions during and following each administration of CosmoFer®.$0$0CosmoFer® should only be administered when staff trainedto evaluate and manage anaphylactic reactions is immediately available, in anenvironment where full resuscitation facilities can be assured. The patientshould be observed for adverse effects for at least 30 minutes followingeach CosmoFer® injection (see section 4.4).'$0$0$0$0$0Removal of wording 'Subsequent doses' $0$0$0$0$0In Total dose infusion:$0$0$0$0Observation time amended $0$0From:$0$0 'at least 1 hour after completion' $0$0To:$0$0 'at least 30 minutes after completion'$0$0$0$0In Intramuscular injection:$0$0Removal of wording 'Following a test dose prior to the first infection the entire doses is administered at once for subsequent intramuscular injections.'$0$0$0In Calculation of dose b) Iron replacement for blood loss:$0$0Change of wording$0$0From:$0$0' If thevolume of blood lost is unknown'$0$0 To:$0$0' If the volume of blood lost is known' $0$0$0$0In 4.3 Contraindications, amendment to the list (asthma, allergic eczema, atopic allergy, rheumatoid arthritis moved to Section 4.4 Special warnings and precautions for use):$0$0Change of wording$0$0From:$0$0$0$0'Non-iron deficiency anaemia(e.g. haemolytic anaemia).$0$0$0$0Ironoverload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis).$0$0$0$0Patients with ahistory of asthma, allergic eczema or other atopic allergy should not betreated by intravenous injection.$0$0$0$0Drughypersensitivity including iron mono- or disaccharide complexes and dextran.$0$0$0$0Decompensated livercirrhosis and hepatitis.$0$0$0$0Acute or chronicinfection, because parenteral iron administration may exacerbate bacterial orviral infections.$0$0$0$0Rheumatoid arthritiswith symptoms or signs of active inflammation.$0$0$0$0Acute renal failure.'$0$0$0$0To:$0$0$0$0'Hypersensitivityto the active substance, to CosmoFer® or any of its excipients listed insection 6.1. $0$0Known serious hypersensitivity to other parenteral iron products.$0$0$0$0Non-iron deficiency anaemia(e.g. haemolytic anaemia).$0$0$0$0Ironoverload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis).$0$0$0$0Decompensated livercirrhosis and hepatitis.$0$0$0$0Acute or chronicinfection, because parenteral iron administration may exacerbate bacterial orviral infections.$0$0$0$0Acute renal failure.'$0$0$0$0 $0$0In 4.4 Specialwarnings and precautions for use$0$0Change of wording:$0$0From:$0$0'The use of CosmoFer®, as with the parenteral use of other iron-carbohydrate complexes, carries a risk ofimmediate severe and potentially lethal anaphylactoid reactions. Patients should be closely observed duringand immediately after administration.  The risk is enhanced for patients with known (medical) allergy. CosmoFer® may only be administered when facilities and equipment for handling acute anaphylactic reactions are available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. For administration of test dose, please refer to section 4.2. $0$0There is particularly increased risk of allergic reactions in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumathoid arthritis).$0$0When parenteral iron therapy is considered essential in patients with asthma, allergic disorders and inflammatory disorders, the intramuscular route is to be preferred.$0$0The intramuscular and subcutaneous injection of iron-carbohydrate complexes in very large doses under experimental conditions in animals produced sarcoma in rats, mice, rabbits, possibly hamsters but not in guinea pigs. Cumulative information and independent assessment indicate that the risk of sarcoma formation in man is minimal.$0$0Hypotensive episodes may occur if intravenous injection is administered too rapidly.'$0$0$0$0To: $0$0'Parenterally administered iron preparations can cause hypersensitivityreactions including serious and potentially fatal anaphylactic/anaphylactoidreactions. Hypersensitivity reactions have also $0$0been reported after previouslyuneventful doses of parenteral iron complexes. $0$0The risk is enhanced for patients with known allergies including drugallergies, including patients with a history of severe asthma, eczema or otheratopic allergy.$0$0There is also an increased risk of hypersensitivity reactions toparenteral iron complexes in patients with immune or inflammatory conditions(e.g. systemic lupus erythematosus, rheumatoid arthritis). $0$0CosmoFer® should only beadministered when staff trained to evaluate and manage anaphylactic reactionsis immediately available, in an environment where full resuscitation facilitiescan be assured. Each patient should be observed for adverse effects for atleast 30 minutes following each CosmoFer® injection. If hypersensitivity reactions or signs of intoleranceoccur during administration, the treatment must be stopped immediately.Facilities for cardio respiratory resuscitation and equipment for handlingacute anaphylactic/anaphylactoidreactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/orcorticosteroids should be given as appropriate. $0$0The intramuscular and subcutaneous injection of iron-carbohydratecomplexes in very large doses under experimental conditions in animals producedsarcoma in rats, mice, rabbits, possibly hamsters but not in guinea pigs.Cumulative information and independent assessment indicate that the risk ofsarcoma formation in man is minimal.$0$0$0$0Hypotensive episodes may occur if intravenous injection is administeredtoo rapidly.'$0$0$0$0$0$0In 4.6 Fertility,pregnancy and lactation$0$0Change of wording:$0$0From:$0$0'There are noadequate data from the use of CosmoFer® inpregnant women. Studies in animals have shown reproductive toxicity (seesection 5.3). CosmoFer® should not be used during thefirst trimester of pregnancy. If the benefit of CosmoFer® treatment is judgedto outweigh the potential risk to the foetus, it is recommended that treatment shouldbe confined to the second and third trimester, if treatment is clearly necessary.$0$0It is unknown whether the complex iron-dextran is excreted in human or animal breast milk. It is preferable to not use CosmoFer® during breast-feeding.'$0$0To:$0$0'There are noadequate and well-controlled trials of CosmoFer® in pregnant women. Studiesin animals have shown reproductive toxicity (see section 5.3). A carefulrisk/benefit evaluation is therefore required before use during pregnancy and CosmoFer®should not be used during pregnancy unless clearly necessary (see section 4.4).$0$0Iron deficiencyanaemia occurring in the first trimester of pregnancy can in many cases betreated with oral iron. Treatment with CosmoFer® should be confinedto second and third trimester if the benefit is judged to outweigh thepotential risk for both the mother and the foetus.$0$0$0$0It is unknownwhether the complex iron-dextran is excreted in human or animal breast milk. Itis preferable to not use CosmoFer® during breast-feeding.'$0$0$0$0$0$0 $0$0In 4.8  Undesirableeffects, addition of wording regarding reporting of side effects:$0$0'Reporting of suspected adverse reactions$0$0Reporting suspectedadverse reactions after authorisation of the medicinal product is important. Itallows continued monitoring of the benefit/risk balance of the medicinalproduct. Healthcare professionals are asked to report any suspected adversereactions via Yellow Card Scheme,$0Website:www.mhra.gov.uk/yellowcard'$0$0 $0$0In Section 10. DATE OF REVISION OF THE TEXT, revision of date:$0$0February 2014$0$0$0$0$0 $0

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-06-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 6.3 the shelf life has changed to 30 months for 2ml ampoules and 24 months for 5ml and 10ml ampoules.
In section 6.4 the warning "Do not freeze" has been added.
In section 6.6 the statement "Inspect ampoules visually for sediment and damage before use. Use only those containing sediment-free, homogeneous solution" has been added. 

Reasons for adding or updating:

  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation

Date of revision of text on the SPC:01-07-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 8 Marketing Authorisation Number has changed from PL 18328/0001 to PL 18380/0002.
In section 10 Date of Revision of Text has changed to 07/2010

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-07-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 10 date of revision of the text has changed to 07/2009.

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Introduction of new pack/pack size
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In Section 2 a 10ml ampoule containing 500mg iron (III) has been added.
In Section 6.5 packs of 2 x 10ml and 5 x 10ml have been added.
In Section 9 the Renewal of the Authorisation has changed to 08/2007.
In Section 10 the Date of Revision of the Text has changed to 08/2007. 

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC:01-06-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

Black Triangle removed as no longer applicable.

Section 4.1  Minor change to wording.

Section 4.2  Repositioning of text to highlight Test dose.

                    (Dosage)  Warning concerning not administering Cosmofer concomitantly with oral iron.

Section 4.4  Repositioning of text to highlight allergic reactions in patients with immune or inflammatory conditions.

Section 4.6  Expansion of the use of Cosmofer in pregnancy.

Section 4.8  Repositioning of text to highlight anaphylactoid reactions. Expansion of undesirable effect table to include sections on the
                      following organ classes: Blood and lymphatic system, Immune system, Psychiatric disorders, Vascular system.

Section 5.3  Change in units, update to in vitro/vivo genotoxicity.

Section 6.6  Addition of intravenous dilution solutions to this section.

Section 10.  Date of revision changed to June 6, 2007.

Reasons for adding or updating:

  • Addition of Black Triangle
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Black Triangle Added
Section 7 MA Holder Pharmacosmos A/S
Section 10 Date of Revision August 14, 2006

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Pending awaiting re-submission

Date of revision of text on the SPC:01-08-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 MA Holder now Pharmacosmos A/S

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Addition of Black Triangle

Date of revision of text on the SPC:01-08-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Black triangle added
Section 10 - date of revision changed

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-03-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to Section 4.2 – Posology and Method of Administration, -   Addition of highlighted text under Intravenous drip infusion section: On each occasion the first 25 mg of iron should be infused over a period of 15 minutes.
Addition of highlighted text under Intravenous injection section: On each occasion before administering a slow intravenous injection, 25 mg of iron should be injected slowly over a period of 1 to 2 minutes. Insertion of the following text at the start of the Intramuscular injection section: Following a test dose prior to the first injection the entire dose is administered at once for subsequent intramuscular injections.
Clarification of symbols in Calculation of dose section: x replaces in calculations.

Change to Section 4.8 – Undesirable Effects, -   Addition of Tachycardia to the Rare section of Cardiovascular System undesirable effects.Deletion of percentages under Common, Uncommon and Rare classifications.
Change to Section 7 – MA Holder, - Change of MA Holder address. Address is now: Nebo a/s, Roervangsvej 30, DK-4300 Holbaek, Denmark.
Change to Section 8 MA Numbers, - Removal of PA Number. SPC now refers only to the UK.
Change to Section 9 – Date of First Authorisation/Renewal of Authorisation, - Date of renewal of authorization changed to March 8 2005
Change to Section 10 – Date of Revision of Text.- Date of revision of text changed to March 10 2005

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Pending awaiting re-submission

Date of revision of text on the SPC:01-03-2005

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2
Addition of the bold text to the Intravenous Drip Infusion section:
On each occasion the first 25mg of iron should be infused over a period of 15 minutes.
 
Addition of the bold text to the Intravenous Injection section:
On each occasion before administering a slow intravenous injection, 25mg of iron should be injected over a period of 1 to 2 minutes.
 
Addition of the following sentence to the Intramuscular Injection section:
Following a test dose prior to the first injection the entire dose is administered at once for subsequent intramuscular injections.
 
Clarification of symbols in the Calculation of dose section.
x replaces • in calculations. 
 
Section 4.8
Addition of Tachycardia as an undesirable effect to the Cardiovascular Organ System.
Percentages removed from common, uncommon and rare effect headings.
 
Section 7
MA holder address change to:
Nebo a/s
Roervangsvej 30
DK-4300 Holbaek
Denmark
 
Section 8
Removal of PA number. Separate SPC's now exist for the UK and Ireland.
 
Section 9
Date of renewal changed to March 8 2005.
 
Section 10
Date of revision of text changed to March 10 2005.
 

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC