Cosmofer

Section 4: Possible side effects: Following changes were done

Allergic reactions (affecting less than 1 in 100 people)

Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction you have an allergic reaction to CosmoFer tell your doctor or nurse straight away so that they can stop it if necessary. The signs of this may include:

•         shortness of breath,

•         nettle rash or hives, flushing, rashes, itching,

•         nausea and shivering., and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

 

 

Reporting of Side effects: Following changes were done

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.hpra.ie.; e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

 

 

This leaflet was last revised in

Deleted: 11/2018

Added: 01/2020

4.4  Special warnings and precautions for use

Following were added in the first paragraph

“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).”

 

 

4.8 Undesirable effects: in the table- Adverse drug reactions observed during clinical trials and post-marketing experience.

Another column “Not known” were added.

In row two under Cardiac Disorders: Kounis Syndrome was added in the Not known column.

 

Section 10 Date of revision of the text

Deleted: 18.10.2019

Added: 23.01.2020

In section 4.6 Fertility, pregnancy and lactation: Following were added

 

“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.”

 

 

In section 4.8 Undesirable effects, reporting of suspected adverse reactions: following were deleted.

“Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517”

And “ e-mail: medsafety@hpra.ie”

 

 

In section 10: Date of revision of text: Date updated to “17.10.2019”

 

4.8 Undesirable effects:

Change to “Undesirable effects”- addition of Not known column

 

From:

Organ System	Uncommon (>1/1,000, <1/100)	Rare (>1/10,000, <1/1,000)	Very rare <1/10,000
Blood and lymphatic system disorders			Haemolysis
Cardiac disorders		Arrythmia, tachycardia	Foetal bradycardia, palpitations
Ear and labyrinth disorders			Transient deafness
Gastrointestinal disorders	Nausea, emesis, abdominal pain	Diarrhoea
General disorders and administration site conditions	Feeling hot	Fatigue   Pain and brown pigmentation at injection site
Immune system disorders	Anaphylactoid reactions including dyspnoea, urticaria, rashes, itching, nausea and shivering		Acute, severe anaphylactoid reactions (sudden onset of respiratory difficulty and / or cardiovascular collapse)
Musculoskeletal and connective tissue disorders	Cramps	Myalgias
Nervous system disorders	Blurred vision, numbness	Loss of consciousness, seizure, dizziness, restlessness, tremor	Headache, paresthesia
Respiratory, thoracic and mediastinal disorders	Dyspnea	Chest pain
Psychiatric disorders		Mental status changes
Skin and subcutaneous tissue disorders	Flushing, pruritus, rash	Angioedema, Sweating
Vascular disorders		Hypotension	Hypertension

 

To:

Organ System	Uncommon (>1/1,000, <1/100)	Rare (>1/10,000, <1/1,000)	Very rare <1/10,000	Not known
Blood and lymphatic system disorders			Haemolysis
Cardiac disorders		Arrythmia, tachycardia	Foetal bradycardia, palpitations
Ear and labyrinth disorders			Transient deafness
Gastrointestinal disorders	Nausea, emesis, abdominal pain	Diarrhoea
General disorders and administration site conditions	Feeling hot	Fatigue   Pain and brown pigmentation at injection site		Influenza like illness whose onset may vary from a few hours to several days
Immune system disorders	Anaphylactoid reactions including dyspnoea, urticaria, rashes, itching, nausea and shivering		Acute, severe anaphylactoid reactions (sudden onset of respiratory difficulty and / or cardiovascular collapse)
Musculoskeletal and connective tissue disorders	Cramps	Myalgias
Nervous system disorders	Blurred vision, numbness	Loss of consciousness, seizure, dizziness, restlessness, tremor	Headache, paresthesia
Respiratory, thoracic and mediastinal disorders	Dyspnea	Chest pain
Psychiatric disorders		Mental status changes
Skin and subcutaneous tissue disorders	Flushing, pruritus, rash	Angioedema, Sweating
Vascular disorders		Hypotension	Hypertension

 

 

 

 

 

 

 

4.8 Undesirable effects:

Change to “Reporting of suspected adverse reaction”

 

From:

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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

 

To:

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

 

 

6.3 Shelf Life:

Change to wording

 

From:

30 months for 2 ml ampoules

24 months for 5 ml and 10 ml ampoules

 

To:

24 months for 2 ml, 5 ml and 10 ml ampoules

 

8 Marketing Authorisation Number(s)

 

From:

PA982/001/001

 

To:

PA0982/001/001

 

9 Date of first authorisation, renewal of authorisation:

Change to wording

 

From:

Date of first approval: 29 June 2001 / 23 September 2009

 

To:

Date of first authorisation: 29 June 2001

Date of latest renewal: 23 September 2009

 

10 Date of revision of the text

Change to wording

 

From:

February 2014

 

To:

11/2018

$0Addition of blacktriangle:$0$0'▼This medicinalproduct is subject to additional monitoring. This will allow quickidentification of new safety information. Healthcare professionals are asked toreport any suspected adverse reactions. See section 4.8 for how to reportadverse reactions.'$0$0 $0$0In Section 2. QUALITATIVE ANDQUANTITATIVE COMPOSITION, change of wording:$0$0From:$0$0'For a full list of excipients, see6.1.'$0$0To:$0$0'For the full list of excipients, seesection 6.1.'$0$0 $0$0In Section 4.2.  Posology andmethod of administration:$0$0 $0$0Removal of test dose.$0$0 $0$0Replaced with:$0$0'Monitor carefully patients for signs andsymptoms of hypersensitivity reactions during and following each administrationof CosmoFer^®.$0$0CosmoFer^® shouldonly 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 CosmoFer^® injection(see section 4.4).'$0$0 $0$0Removal of wording 'Subsequent doses' $0$0 $0$0In Total dose infusion:$0$0Observation time amended $0$0From:$0$0 'at least 1 hour aftercompletion' $0$0To:$0$0 'at least 30 minutes aftercompletion'$0$0 $0$0In Intramuscular injection:$0$0Removal of wording 'Following a test dose prior to the first infection the entiredoses is administered at once for subsequent intramuscular injections.'$0$0$0$0$0In Calculation of dose b) Ironreplacement for blood loss:$0$0Change of wording$0$0From:$0$0' If the volume ofblood lost is unknown'$0$0 To:$0$0' If the volume ofblood lost is known' $0$0 $0$0In 4.3 Contraindications, amendment tothe list (asthma, allergic eczema, atopicallergy, rheumatoid arthritis moved to Section 4.4 Special warnings andprecautions for use):$0$0Change of wording$0$0From:$0$0'Non-iron deficiency anaemia (e.g.haemolytic anaemia).$0$0Iron overload or disturbances inutilisation of iron (e.g. haemochromatosis, haemosiderosis).$0$0Patients with a history of asthma,allergic eczema or other atopic allergy should not be treated by intravenousinjection.$0$0Drug hypersensitivity including ironmono- or disaccharide complexes and dextran.$0$0Decompensated liver cirrhosis andhepatitis.$0$0Acute or chronic infection, becauseparenteral iron administration may exacerbate bacterial or viral infections.$0$0Rheumatoid arthritis with symptoms orsigns of active inflammation.$0$0Acute renal failure.'$0$0 $0$0To:$0$0'Hypersensitivity to the activesubstance, to CosmoFer® or any of its excipients listed in section 6.1.$0$0Known serious hypersensitivity to otherparenteral iron products.$0$0Non-iron deficiency anaemia (e.g.haemolytic anaemia).$0$0Iron overload or disturbances inutilisation of iron (e.g. haemochromatosis, haemosiderosis).$0$0Decompensated liver cirrhosis andhepatitis.$0$0Acute or chronic infection, becauseparenteral iron administration may exacerbate bacterial or viral infections.$0$0Acute renal failure.'$0$0 $0$0In 4.4 Special warnings 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 riskof immediate severe and potentially lethal anaphylactoid reactions. Patients should be closely observed during and immediately after administration.  The risk is enhanced for patients with known(medical) allergy. CosmoFer^® may only be administered whenfacilities and equipment for handling acute anaphylactic reactionsare available, including an injectable 1:1000 adrenaline solution.Additional treatment with antihistamines and/or corticosteroids should be givenas appropriate. For administration of test dose, pleaserefer to section 4.2. $0$0There is particularly increased risk ofallergic reactions in patients with immune or inflammatory conditions (e.g.systemic lupus erythematosus, rheumathoid arthritis).$0$0When parenteral iron therapy is consideredessential in patients with asthma, allergic disorders and inflammatorydisorders, the intramuscular route is to be preferred.$0$0The intramuscular and subcutaneousinjection of iron-carbohydrate complexes in very large doses under experimentalconditions in animals produced sarcoma in rats, mice, rabbits, possiblyhamsters but not in guinea pigs. Cumulative information and independentassessment indicate that the risk of sarcoma formation in man is minimal.$0$0Hypotensive episodes may occur ifintravenous injection is administered too rapidly.'$0$0 $0$0To: $0$0'Parenterally administered ironpreparations can cause hypersensitivity reactions including serious andpotentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivityreactions have also been reported after previously uneventful dosesof parenteral iron complexes. $0$0The risk isenhanced for patients with known allergies including drug allergies, includingpatients with a history of severe asthma, eczema or other atopic allergy.$0$0There is alsoan increased risk of hypersensitivity reactions to parenteral iron complexes inpatients with immune or inflammatory conditions (e.g. systemic lupuserythematosus, 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 reactionsor signs of intolerance occur during administration, the treatment must bestopped immediately. Facilities for cardio respiratory resuscitation andequipment for handling acute anaphylactic/anaphylactoid reactions shouldbe available, including an injectable 1:1000 adrenaline solution.Additional treatment with antihistamines and/or corticosteroids should be givenas appropriate. $0$0The intramuscular and subcutaneousinjection of iron-carbohydrate complexes in very large doses under experimentalconditions in animals produced sarcoma in rats, mice, rabbits, possiblyhamsters but not in guinea pigs. Cumulative information and independentassessment indicate that the risk of sarcoma formation in man is minimal.$0$0Hypotensive episodes may occur ifintravenous injection is administered too rapidly.'$0$0 $0$0In 4.6 Fertility, pregnancy andlactation$0$0Change of wording:$0$0From:$0$0‘There are no adequate data from the use of CosmoFer^®in pregnant women. Studies in animals have shown reproductive toxicity (seesection 5.3). CosmoFer® should not be used during the first trimester ofpregnancy. If the benefit of CosmoFer® treatment is judged to outweigh thepotential risk to the foetus, it is recommended that treatment should beconfined to the second and third trimester, if treatment is clearly necessary.$0$0It is unknown whether the complexiron-dextran is excreted in human or animal breast milk. It is preferable tonot use CosmoFer® during breast-feeding.'$0$0To:$0$0‘There are noadequate and well-controlled trials of CosmoFer® in pregnant women. A carefulrisk/benefit evaluation is therefore required before use during pregnancy andCosmoFer® 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. Studies in animals have shown reproductivetoxicity (see section 5.3). Treatment with CosmoFer® should be confined tosecond and third trimester if the benefit is judged to outweigh the potentialrisk for both the mother and the foetus.$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$0In 4.8  Undesirable effects, addition of wording regarding reporting of sideeffects:$0$0'Reportingof suspected adverse 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 IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;Tel: +353 1 6764971;  Fax: +353 16762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie$0$0 $0$0In 5.1 Pharmacodynamic properties$0$0Change of wording$0$0From: $0$0Pharmacotherapeuticgroup: Iron trivalent parenteral preparation, ATC code: B03A C06$0$0To: $0$0Pharmacotherapeuticgroup: Iron parenteral preparation, ATC code: B03AC$0$0 $0$0In 9. DATE OF FIRSTAUTHORISATION/RENEWAL OF THE AUTHORISATION$0$0Wording changed to include renewaldate:$0$0Date of firstapproval: 29 June 2001 / 23 September 2009$0$0 $0$0In Section 10. DATE OF REVISION OF THE TEXT, revision of date:$0$0February 2014$0$0$0$0$0 $0$0 $0

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