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Pharmacosmos UK Limited

The White Building, 33 Kings Road, Reading, Berkshire, RG1 3AR, UK
Telephone: +44 (0)1844 269 007
Fax: +44 (0)1844 269 005
Medical Information Direct Line: +44 (0)1844 269 007
Medical Information e-mail: medinfo@pharmacosmos.co.uk
Medical Information Facsimile: +44 (0)1844 269 005
Summary of Product Characteristics last updated on medicines.ie: 16/06/2017
SPC Monover 100mg/ml solution for injection/infusion

When a pharmaceutical company changes an SPC or PIL, 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 16/06/2017 and displayed until Current
Reasons for adding or 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-May-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0In section 4.2Posology and method of administration$0$0Addition towording under ‘simplified table, wording added:$0$0The treatment effect should be monitored byblood tests. To reach the target Hb-level, the cumulative iron dose may needadjustment.$0$0$0$0$0In section 4.3Contraindications$0$0Change towording$0$0From:$0$0Decompensatedliver cirrhosis and hepatitis$0$0To:$0$0Decompensatedliver disease$0$0$0$0$0In section 4.4Special warnings and precautions for use$0$0Additionalwording added:$0$0In patients with compensated liver dysfunction,parenteral iron should only be administered after careful benefit/riskassessment. Parenteral iron administration should be avoided in patients withhepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase> 3 times upper limit of normal) where iron overload is a precipitatingfactor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of ironstatus is recommended to avoid iron overload.$0$0Caution should be exercised to avoidparavenous leakage when administrating Monover. Paravenous leakage of Monoverat the injection site may lead to irritation of the skin and potentially longlasting brown discolouration at the site of injection. In case of paravenousleakage, the administration of Monover must be stopped immediately.$0$0 $0$0In section 4.6Fertility, pregnancy and lactation$0$0Sub headingadded in first paragraph:$0$0Pregnancy$0$0Removal ofwording in first paragraph:$0$0(see section 4.4)$0$0Addition ofwording in second paragraph, wording added:$0$0In rare cases, foetal bradycardia has beenobserved in pregnant women with hypersensitivity reactions (see section 4.8).$0$0Change towording$0$0From:$0$0There is no information available on theexcretion of Monover in human breast milk. $0$0To:$0$0Breast-feeding$0$0A clinical study showed that transfer of ironfrom Monover to human milk was very low. At therapeutic doses of Monover noeffects on the breastfeed newborns/infants are anticipated.$0$0Additionalwording added:$0$0Fertility$0$0There are no data on the effect of Monover onhuman fertility. Fertility was unaffected following Monover treatment in animalstudies (see section 5.3).$0$0 $0$0In section 4.8Undesirable effects$0$0Additionalwording added:$0$0The table presents the adverse drug reactions(ADRs) reported during Monover treatment in clinical trials and in-marketexperience.$0$0Acute severe hypersensitivity reactions mayoccur with parenteral iron preparations. They usually occur within the firstfew minutes of administration and are generally characterised by the suddenonset of respiratory difficulty and/or cardiovascular collapse; fatalities havebeen reported. Other less severe manifestations of immediate hypersensitivity,such as urticaria and itching may also occur. In pregnancy, associated foetalbradycardia may occur with parenteral iron preparations.$0$0Flushing in the face, acute chest and/or backpain and tightness sometimes with dyspnea in association with IV iron treatmentmay occur (frequency uncommon). This may mimic the early symptoms of ananaphylactoid/anaphylactic reaction. The infusion should be stopped and thepatient's vital signs should be assessed. These symptoms disappear shortlyafter the iron administration is stopped. They typically do not reoccur if theadministration is restarted at a lower infusion rate.$0$0Change toadverse event reaction overview:$0$0From:$0$0Due to limited clinical data on Monoverthe mentioned undesirable effects are primarily based on safety data for otherparenteral iron solutions.$0$0More than 1% of patients may be expectedto experience adverse reactions.$0$0Acute, severe anaphylactoid reactionsmay occur with parenteral iron preparations, although they are uncommon. Theyusually occur within the first few minutes of administration and are generallycharacterised by the sudden onset of respiratory difficulty and / orcardiovascular collapse; fatalities have been reported. Other less severemanifestations of immediate hypersensitivity are also uncommon and includeurticaria, rashes, itching, nausea and shivering. Administration must bestopped immediately if signs of an anaphylactoid reaction are observed.$0$0Delayed reactions may also occur withparenteral iron preparations and can be severe. They are characterised byarthralgia, myalgia and sometimes fever. The onset varies from several hours upto four days after administration. Symptoms usually last two to four days andsettle spontaneously or following the use of simple analgesics. In addition,exacerbation of joint pain in rheumatoid arthritis can occur and localreactions may cause pain and inflammation at or near injection site and a localphlebitic reaction.$0$0$0$0$0Very common (≥1/10)$0$0Common (≥1/100 to <1/10)$0$0Uncommon (≥1/1,000 to <1/100)$0$0Rare (≥1/10,000 to <1/1,000)$0$0Very Rare (<1/10,000)$0$0Not known (cannot be estimated with the availabledata)$0$0 $0$0Cardiac disorders $0$0Rare: Arrhythmia, tachycardia$0$0Very rare: Foetal bradycardia,palpitations$0$0 $0$0Blood and lymphatic system disorders$0$0Very rare: Haemolysis$0$0 $0$0Nervous system disorders$0$0Uncommon: Blurred vision, numbness,dysphonia$0$0Rare: Loss of consciousness, seizure,dizziness, restlessness, tremor, fatigue, altered mental status$0$0Very rare: Headache, paresthesia$0$0 $0$0Ear and labyrinth disorders$0$0Very rare: Transient deafness$0$0 $0$0Respiratory, thoracic and mediastinaldisorders$0$0Uncommon: Dyspnoea$0$0Rare: Chest pain$0$0 $0$0Gastrointestinal disorders$0$0Uncommon: Nausea, emesis, abdominalpain, constipation$0$0Rare: Diarrhoea$0$0 $0$0Skin and subcutaneous tissue disorders$0$0Uncommon: Flushing, pruritus, rash$0$0Rare: Angioedema, sweating$0$0 $0$0Musculoskeletal and connective tissue disorders$0$0Uncommon: Cramps$0$0Rare: Myalgias, arthralgia$0$0 $0$0Vascular disorders$0$0Rare: Hypotension$0$0Very rare: Hypertension$0$0 $0$0General disorders and administration siteconditions$0$0Uncommon: Anaphylactoid reactions,feeling hot, fever, soreness, inflammation near the injection site, localphlebitic reaction$0$0Rare: Fatigue$0$0Very rare: Acute severe anaphylacticreactions$0$0$0$0$0To:$0$0Adverse drug reactionsobserved during clinical trials and post-marketing experience$0$0 $0$0$0$0$0$0System Organ Class$0$0$0$0Common (≥1/100 to <1/10) $0$0$0$0Uncommon (≥1/1000 to <1/100) $0$0$0$0Rare (≥1/10000 to <1/1000) $0$0$0$0$0$0Immune system disorders$0$0$0$0 $0$0$0$0Hypersensitivity, including severe reactions$0$0$0$0Anaphylactoid/$0$0anaphylactic reactions $0$0$0$0$0$0Nervous system disorders$0$0$0$0$0$0Headache, paraesthesia, dysgeusia, blurred vision, $0$0loss of consciousness, dizziness, fatigue$0$0$0$0Dysphonia, seizure,$0$0tremor, altered mental status$0$0$0$0$0$0Cardiac disorders$0$0$0$0 $0$0$0$0Tachycardia $0$0$0$0Arrhythmia$0$0$0$0$0$0Vascular disorders$0$0$0$0$0$0Hypotension, hypertension$0$0$0$0$0$0$0$0Respiratory, thoracic and mediastinal disorders$0$0$0$0 $0$0$0$0Chest pain, dyspnoea, bronchospasm $0$0$0$0$0$0$0$0Gastrointestinal disorders$0$0$0$0Nausea $0$0$0$0Abdominal pain, vomiting, dyspepsia, constipation, diarrhoea $0$0$0$0$0$0$0$0Skin and subcutaneous tissue disorders$0$0$0$0 $0$0$0$0Pruritus, urticaria, rash, flushing, sweating, dermatitis$0$0$0$0Angioedema$0$0$0$0$0$0Metabolism and nutritional disorders$0$0$0$0 $0$0$0$0Hypophosphataemia         $0$0 $0$0$0$0 $0$0$0$0$0$0Musculoskeletal and connective tissue disorders $0$0$0$0 $0$0$0$0Back pain, myalgia*, arthralgia*, muscle spasms $0$0$0$0 $0$0$0$0$0$0General disorders and administration site conditions$0$0$0$0Injection site reactions*$0$0$0$0Pyrexia*, chills/shivering, infection, local phlebitic reaction $0$0$0$0Malaise, influenza like symptoms $0$0$0$0$0$0Investigations $0$0$0$0 $0$0$0$0Hepatic enzyme increased $0$0$0$0 $0$0$0$0$0$0*Includes the following preferred terms, i.e. injection site erythema,-swelling, -burning, -pain, -bruising, -discolouration, -extravasation,-irritation, -reaction.$0$0Description of selectedadverse reactions$0$0Delayed reactions may alsooccur with parenteral iron preparations and can be severe. They arecharacterised by arthralgia, myalgia and sometimes fever. The onset varies fromseveral hours up to four days after administration. Symptoms usually last twoto four days and settle spontaneously or following the use of simpleanalgesics.$0$0 $0$0$0$0$0In section 5.1Pharmacodynamic properties$0$0Additional wording added:$0$0The Monover formulationcontains iron in a complex that enables a controlled and slow release ofbioavailable iron to iron-binding proteins with little risk of free iron.$0$0Change to wording:$0$0From:$0$0Eachparticle consists of an iron(III) core and a carbohydrate shell ofisomaltosides that surrounds and stabilises the core. The chelation ofiron(III) with a carbohydrate shell confers to the particles a structureresembling ferritin that is suggested to protect against the toxicity ofunbound inorganic iron(III). $0$0The iron is available in a non-ionic water-soluble form in an aqueoussolution with pH between 5.0 and 7.0. The toxicity is low and Monover can therefore be administered in largedoses.$0$0To:$0$0Each particle consists of amatrix of iron(III) atoms andisomaltoside pentamers. The chelation of iron(III)with carbohydrate confers to the particles a structure resembling ferritin thatis suggested to protect against the toxicity of unbound inorganic iron(III).$0$0The iron is available in anon-ionic water-soluble form in an aqueous solution with pH between 5.0 and7.0.$0$0Addition of wording added:$0$0Due to the slow release ofbioavailable iron serum ferritin peaks within days after an intravenous dose ofMonover and slowly returns to baseline after weeks.$0$0Removal of wording:$0$0Serum ferritin peaksapproximately 7 to 9 days after an intravenous dose of Monover and slowlyreturns to baseline after about 3 weeks.$0$0Additional wording added:$0$0Clinical efficacy$0$0The efficacy of Monover hasbeen studied in the different therapeutic areas necessitating IV iron tocorrect iron deficiency. The main trials are described in more detail below.$0$0Iron deficiency anaemiaoutside CKD$0$0The P-Monover-IDA-01 trialwas an open-label, comparative, randomised, multi-centre, non-inferiority trialconducted in 511 patients with IDA randomised 2:1 to either Monover or ironsucrose.  90 % of recruited patients werefemales. The dosing of Monover was performed according to the Simplified Tableas described in section 4.2 above and dosing of iron sucrose was calculatedaccording to Ganzoni and administered as 200 mg infusions. The primary endpointwas the proportion of patients with an Hb increase ≥2 g/dL from baseline at anytime between weeks 1 to 5. A higher proportion of patients treated with Monovercompared to iron sucrose reached the primary endpoint, 68.5% vs 51.6%,respectively.(FAS, p < 0.0001). $0$0Nephrology$0$0Non-dialysis-dependent chronic kidney disease $0$0The P-Monofer-CKD-02 trialwas an open-label, comparative, randomised, multi-centre, non-inferiority trialconducted in 351 iron deficient non-dialysis dependent (NDD) chronic kidneydisease (CKD) patients, randomised 2:1 to either Monover or oral iron sulphateadministered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks.The patients in the Monover group were randomized to infusion of 1000 mg singledose or bolus injections of 500 mg.Monover was both non-inferior to oral ironat week 4 (p<0.001) and  alsosustained a superior increase in Hb compared to oral iron from week 3 until theend of trial at week 8 (p=0.009 at week 3). $0$0Haemodialysis-dependent chronic kidney disease$0$0The P-Monofer-CKD-03 trialwas an open-label, comparative, randomised, multi-centre, non-inferiority trialconducted in 351 haemodialysis patients randomised 2:1 to either Monover oriron sucrose. Patients were randomised to either a single injection of 500 mg or500 mg in split doses of Monover or 500 mg iron sucrose in split doses. Bothtreatments showed similar efficacy with more than 82% of patients with Hb inthe target range (non-inferiority, p=0.01).$0$0Oncology$0$0Cancer related anaemia$0$0The P-Monofer-CIA-01 trialwas an open-label, comparative, randomised, multi-centre, non-inferiority trialconducted in 350 cancer patients with anaemia randomised 2:1 to either Monoveror oral iron sulphate administered as 100 mg elemental oral iron twice daily(200 mg daily) for 12 weeks. The patients in the Monover group were randomisedto either an infusion of max 1000 mg single doses over 15 min or bolusinjections of 500 mg over 2 min. The primary endpoint was change in Hbconcentrations from baseline to week 4. Monover was non-inferior to oral ironat week 4 (p<0.001) and a faster onset of the Hb response was observed withinfusion of Monover. $0$0Gastroenterology$0$0Inflammatory bowel disease$0$0The P-Monofer-IBD-01 trialwas an open-label, comparative, randomised, multi-centre, non-inferiority trialconducted in 338 inflammatory bowel disease (IBD) patients randomised 2:1 toreceive either Monover or oral iron sulphate administered as 100 mg elementaloral iron twice daily for 8 weeks (200 mg daily). The patients in the Monovergroup were randomised to either an infusion of max 1000 mg single doses over 15min or bolus injections of 500 mg over 2 min. A modified Ganzoni formula wasused to calculate the IV iron need with a target Hb of only 13 g/dL resultingin an average iron dose of 884 mg elemental iron compared to oral ironadministered as 200 mg oral iron sulfate once daily for 8 weeks (11,200 mgelemental$0$0oral iron in total). Theprimary endpoint was change in Hb concentrations from baseline to week 8. Thepatients had mild to moderate disease activity. Non-inferiority in change of Hbto week 8 could not be demonstrated. The dose-response relationship observedwith Monover suggests that the true iron demand of IV iron was underestimatedby the modified Ganzoni formula. The Hb response rate was 93% for patientsreceiving > 1000 mg Monover. $0$0Women's health$0$0Postpartum$0$0The P-Monofer-PP-01 trialwas an open-label, comparative, randomised, single-centre, non-inferioritytrial conducted in 200 healthy women withpostpartum haemorrhage exceeding 700 mL within 48 hours after delivery.The women were randomised 1:1 to receive either a single dose of 1200 mg Monoveror standard medical care. The primary endpoint was the aggregated change inphysical fatigue within 12 weeks postpartum. The difference in aggregatedchange in physical fatigue score within 12 weeks postpartum was -0.97(p=0.006), in favour of Monover.$0$0$0$0$0In section 5.2 Pharmacokinetic properties$0$0Change towording in first and second paragraph:$0$0From:$0$0TheMonover formulation contains iron in a strongly bound complex that enables acontrolled and slow release of bioavailable iron to iron-binding proteins withlittle risk of free iron.$0$0Followingintravenous administration, iron isomaltoside 1000 is rapidly taken up by thecells in the reticuloendothelial system (RES), particularly in the liver andspleen from where iron is slowly released. The plasma half life is 5 hours forcirculating iron and 20 hours for total iron (bound and circulating).$0$0To:$0$0TheMonover formulation contains iron in a strongly bound complex that enables acontrolled and slow release of bioavailable iron to iron-binding proteins withlittle risk of free iron toxicity. After administration of a single dose ofMonover of 100 to 1000 mg of iron in pharmacokinetic studies, the iron injectedor infused was cleared from the plasma with a half-life that ranged from 1 to 4days. Renal elimination of iron was negligible.$0$0Followingintravenous administration, iron isomaltoside 1000 is rapidly taken up by thecells in the reticuloendothelial system (RES), particularly in the liver andspleen from where iron is slowly released.$0$0$0$0$0In section 5.3 Preclinical safety data$0$0Change towording:$0$0From:$0$0Iron complexes have been reported to beteratogenic and embryocidal in non-anaemic pregnant animals at high singledoses above 125 mg iron/kg body weight. The highest recommended dose inclinical use is 20 mg iron/kg body weight.$0$0There are no other additional preclinical dataof relevance to the prescriber than those already included in other sections ofthe SPC.$0$0To:$0$0Iron complexes have been reported to be teratogenic andembryocidal in non-anaemic pregnant animals at high single doses above 125 mgiron/kg body weight. The highest recommended dose in clinical use is 20 mgiron/kg body weight.$0$0In a fertility study with Monover in rats no effects onmale reproductive performance and spermatogenic parameters were found at doselevel tested. $0$0 $0$0In section 10. DATE OF REVISION OF THE TEXT, change of date:$0$0 $0$0From: $0$02015-10-15$0$0To:$0$02017-05-19 $0$0 $0$0 $0$0 $0$0 $0
Updated on 23/11/2015 and displayed until 16/06/2017
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Oct-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0In section 4.1,Therapeutic indications$0$0 $0$0Change of wording $0$0From:$0$0Monoveris indicated for the treatment of iron deficiency anaemia in the followingconditions:$0$0•           When oral iron preparations areineffective or cannot be used$0$0•           Where there is a clinical need todeliver iron rapidly         $0$0Thediagnosis of iron deficiency anaemia should be based on appropriate laboratorytests (e.g. serum ferritin, serum iron, transferrin saturation or hypochromicred cells).$0$0To:$0$0Monoveris indicated for the treatment of iron deficiency in the following conditions:$0$0•           When oral iron preparations areineffective or cannot be used$0$0•           Where there is a clinical need todeliver iron rapidly         $0$0Thediagnosis must be based on laboratory tests.$0$0 $0$0In section 4.2, Posologyand method of administration$0$0 $0$0Changes to subheading and wording under ‘Calculation of thecumulative iron dose:’$0$0 $0$0From:$0$0Calculation of the cumulative iron dose:$0$0Iron replacement in patients with iron deficiencyanaemia:$0$0The dose and dosage schedule for Monover must beindividually established for each patient. The optimal haemoglobin target leveland iron stores may vary in different patient groups and between patients.Please refer to official guidelines. The dose of Monover is expressed in mg ofelemental iron.$0$0To:$0$0Calculation of the cumulative iron need:$0$0Iron replacement in patients with iron deficiency:$0$0The dose of Monover is expressed in mg of elemental iron.The iron need and the administration schedule for Monover must be individuallyestablished for each patient. The optimal haemoglobin target level and ironstores may vary in different patient groups and between patients. Please referto official guidelines. $0$0 $0$0From:$0$0The cumulative iron dose can be determined using eitherthe Ganzoni formula (1) or the dosing table below (2).$0$0 $0$0To:$0$0The cumulative iron need can be determined using eitherthe Ganzoni formula (1) or the Table below (2)$0$0 $0$0Change to wordingunder ‘Ganzoni Formula’:$0$0 $0$0From:$0$0Iron dose  =  Bodyweight(A)  x  (Target Hb – Actual Hb)(B)  x  2.4(C)  +  Ironfor iron stores(D)$0[mg iron]             [kg]                                [g/dl][mg iron]$0$0 $0$0(A)       It isrecommended to use the patient’s ideal body weight or pre-pregnancy weight$0$0(B)       To convertHb [mM] to Hb [g/dl] you should multiply Hb [mM] by factor 1.61145$0$0(C)       Factor 2.4= 0.0034 x 0.07 x 10,000$0$0            0.0034: Iron content of haemoglobinis 0.34%$0$0            0.07:Blood volume 70 ml/kg of body weight »7% of body weight$0$0            10,000:The conversion factor 1 g/dl = 10,000 mg/l$0$0(D)       For aperson with a body weight above 35 kg, the iron stores are 500 mg or above$0$0 $0$0To:$0$0Iron need  =  Bodyweight(A)  x  (Target Hb(E) – Actual Hb)(B)  x  2.4(C)  +  Ironfor iron stores(D)$0[mg iron]             [kg]                                [g/dl][mg iron]$0$0 $0$0(A)       It isrecommended to use the patient’s ideal body weight for obese patients orpre-pregnancy weight for pregnant women. Ideal body weight may becalculated in a number of ways e.g. by calculating weight at BMI 25 i.e. idealbody weight = 25 * (height in m)2$0$0(B)       To convertHb [mM] to Hb [g/dl] you should multiply Hb [mM] by factor 1.61145$0$0(C)       Factor 2.4= 0.0034 x 0.07 x 10,000$0$0            0.0034: Iron content of haemoglobinis 0.34%$0$0            0.07:Blood volume 70 ml/kg of body weight »7% of body weight$0$0            10,000:The conversion factor 1 g/dl = 10,000 mg/l$0$0(D)       For aperson with a body weight above 35 kg,the iron stores are 500 mg or above. Iron stores of 500 mg are atthe lower limit normal for small women. Some guidelines suggest using 10-15 mgiron /kg body weight. $0$0(E)       Default Hb target is 15 g/dl in theGanzoni formula. In special cases such as pregnancy consider using a lowerhaemoglobin target.$0$0 $0$0Change to wordingunder ‘Dosing table’:$0$0 $0$0From:$0$02.         Dosing table:$0$0Cumulative iron dose$0$0To:$0$02.         Simplified Table:$0$0Iron need$0$0 $0$0Change to wordingunder ‘iron replacement for blood loss’:$0$0 $0$0From:$0$0Iron therapy in patientswith blood loss should supply an amount of iron equivalent to the amount ofiron represented in the blood loss.$0$0·If the Hb level is reduced: Use theGanzoni formula considering that the depot iron does not need to be restored: $0$0 $0$0Cumulative iron dose=  Body weight  x(Target Hb – Actual Hb)  x  2.4$0[mgiron]                         [kg]                             [g/dl]$0$0To:$0$0Iron therapy in patientswith blood loss should supply an amount of iron equivalent to the amount ofiron represented in the blood loss.$0$0·If the Hb level is reduced: Use theGanzoni formula considering that the depot iron does not need to be restored: $0$0 $0$0Ironneed  =Body weight  x  (Target Hb – Actual Hb)  x  2.4$0[mg iron]            [kg]                            [g/dl]$0$0 $0$0Addition of wordingunder ‘Administration’, wording added:$0$0Each IV iron administration is associated with a risk ofa hypersensitivity reaction. Thus, to minimise risk the number of single IViron administrations should be kept to a minimum. $0$0 $0$0Change of wordingunder ‘Intravenous bolus infusion’:$0$0 $0$0From:$0$0Monovermay be administered as an intravenous bolus injection up to 500 mg up to threetimes a week at an administration rate of up to 50 mg iron/minute.$0$0To:$0$0Monovermay be administered as an intravenous bolus injection up to 500 mg up to threetimes a week at an administration rate of up to 250 mg iron/minute.$0$0 $0$0 $0$0Change of wordingunder ‘Intravenous drip infusion’:$0$0 $0$0From:$0$0If the cumulative iron doseexceeds 20 mg iron/kg body weight, the dose must be split in twoadministrations with an interval of at least one week.$0$0Doses up to 1000 mg must beinfused over 30 min.$0$0Doses exceeding 1000 mg mustbe infused over 60 min.$0$0To:$0$0If the cumulative iron doseexceeds 20 mg iron/kg body weight, the dose must be split in twoadministrations with an interval of at least one week. It is recommendedwhenever possible to give 20 mg iron/kg body weight in the firstadministration. Dependent on clinical judgement the second administration couldawait follow-up laboratory tests.$0$0Doses up to 1000 mg must beadministered over more than 15 minutes.$0$0Doses exceeding 1000 mg mustbe administered over 30 minutes or more.$0$0 $0$0In section 6.3,Shelf life, removal of wording:$0$0 $0$0From:$0$0Shelf life after dilution with sterile 0.9% sodiumchloride:$0$0Chemical andphysical in-use stability has been demonstrated for 48 hours at 30°C indilutions up to 1:250 with sterile 0.9% sodium chloride.$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 the responsibilityof the user and would normally not be longer than 24 hours at 2°C to 8°C,unless dilution has taken place in controlled and validated aseptic conditions.$0$0 $0$0To:$0$0Shelf life after dilution with sterile 0.9% sodiumchloride:$0$0Chemical andphysical in-use stability has been demonstrated for 48 hours at 30°C in dilutions up to 1:250 withsterile 0.9% sodium chloride.$0$0From amicrobiological point of view, the product should be used immediately. $0$0 $0$0In section 10, Date of revision of the text, change ofdate:$0$0From: 2015-04-15$0$0To: 15 October 2015$0
Updated on 09/07/2015 and displayed until 23/11/2015
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   15-Apr-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0In section 9. DATEOF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION$0$0The date for the renewal of the authorisation has been added:$0$0Date of first authorisation: 9thApril 2010$0$0Renewal of the authorisation: 26th November 2014$0$0 $0$0In section 10. DATEOF REVISION OF THE TEXT$0$0The date has been amended to:$0$0 2015-04-15$0
Updated on 09/04/2014 and displayed until 09/07/2015
Reasons for adding or updating:
  • Addition of black triangle
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10-Mar-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

$0Addition of blacktriangle wording:$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$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 4.2 Posology and method ofadministration$0$0Change of wording under‘Administration’$0$0From:$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 Monover, any signs of a hypersensitivity reactionor intolerance are detected, administration must be stopped immediately.$0$0Resuscitativemedication and personnel trained to evaluate and handle anaphylactoid reactionsshould be available whenever a dose of parenteral iron is administered.$0$0To:$0$0Monitorcarefully patients for signs and symptoms of hypersensitivity reactions duringand following each administration of Monover.$0$0Monovershould only be administered when staff trained to evaluate and manageanaphylactic reactions is immediately available, in an environment where fullresuscitation facilities can be assured. The patient should be observed foradverse effects for at least 30 minutes following each Monover injection (seesection 4.4).$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$0Non-iron deficiency anaemia (e.g. haemolytic anaemia)$0$0Iron overload or disturbances in utilisation of iron (e.g.haemochromatosis, haemosiderosis)$0$0Hypersensitivity to the active substance or to any of the excipients.$0$0Patients with a history of asthma, allergic eczema or other atopicallergy$0$0Decompensated liver cirrhosis and hepatitis$0$0Rheumatoid arthritis with symptoms or signs of active inflammation$0$0 $0$0To: $0$0 $0$0Hypersensitivity to the active substance, to Monover or any of itsexcipients listed in section 6.1.$0$0Known serious hypersensitivity to other parenteral iron products.$0$0Non-iron deficiency anaemia (e.g. haemolytic anaemia)$0$0Iron overload or disturbances in utilisation of iron (e.g.haemochromatosis, haemosiderosis)$0$0Decompensated liver cirrhosis and hepatitis$0$0 $0$0In 4.4    Special warnings and precautions for use$0$0Change of wording $0$0From:$0$0Parenteraladministration of all iron complexes may cause immediate severe and potentiallylethal hypersensitivity reactions. $0$0Therisk is enhanced for patients with known (medical) allergies. Resuscitativemedication and personnel trained to evaluate and handle anaphylactoid reactionsshould therefore be available.$0$0Thereis particularly increased risk of allergic reactions to parenteral ironcomplexes in patients with immune or inflammatory conditions (e.g. systemiclupus erythematosus, rheumathoid arthritis).$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$0Therisk is enhanced for patients with known allergies including drug allergies,including patients with a history of severe asthma, eczema or other atopicallergy.$0$0Thereis also an increased risk of hypersensitivity reactions to parenteral ironcomplexes in patients with immune or inflammatory conditions (e.g. systemiclupus erythematosus, rheumatoid arthritis).$0$0Monovershould 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 Monover 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$0In 4.6    Fertility, pregnancy and lactation$0$0Change of wording$0$0From:$0$0Thereare no adequate and well-controlled trials of Monover in pregnant women. Acareful risk/benefit evaluation is therefore required before use duringpregnancy and Monover 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 Monover treatment is judgedto outweigh the potential risk to the foetus, the treatment should be confinedto second and third trimester.$0$0 $0$0To:$0$0Thereare no adequate and well-controlled trials of Monover in pregnant women. Acareful risk/benefit evaluation is therefore required before use duringpregnancy and Monover should not be used during pregnancy unless clearlynecessary (see section 4.4).$0$0Irondeficiency anaemia occurring in the first trimester of pregnancy can in manycases be treated with oral iron. Treatment with Monover should be confined tosecond and third trimester if the benefit is judged to outweigh the potentialrisk for both the mother and the foetus.$0$0 $0$0In 4.8    Undesirable effects, addition of wording regarding reporting ofside effects:$0$0 $0$0Reporting of suspected adverse reactions$0$0Reporting suspected adversereactions after authorisation of the medicinal product is important. It allowscontinued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactionsvia Pharmacovigilance Section, IrishMedicines Board, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace,Dublin 2, $0$0Tel: +353 1 6764971, Fax: +353 1 6762517.Website: www.imb.ie, $0$0e-mail:imbpharmacovigilance@imb.ie$0$0 $0$0In 5.1    Pharmacodynamic properties$0$0Change of wording and ATC Code:$0$0From:$0$0Pharmacotherapeuticgroup: Iron trivalent parenteral preparation, ATC code: B03A C06$0$0 $0$0To:$0$0Pharmacotherapeuticgroup: Iron parenteral preparation, ATC code: B03AC$0$0 $0$0In 6.4    Special precautions for storage$0$0Change of wording$0$0From:$0$0Thismedicinal product does not require any special storage conditions.$0$0Forstorage conditions of the reconstituted and diluted solution see 6.3.$0$0 $0$0To:$0$0Thismedicinal product does not require any special storage conditions.$0$0Forstorage conditions of the reconstituted and diluted solution see section 6.3.$0$0 $0$0In 10 DATEOF REVISION OF THE TEXT, revision of date:$0$02014-03-10$0$0 $0$0 $0
Updated on 10/07/2013 and displayed until 09/04/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.2:

Change of wording from total iron dose to cumulative iron dose.

 

Inclusion of a fixed dose table option in addition to the Ganzoni calculation for estimation of the iron need.

 

Under Iron replacement for blood loss:  Correction of error in previous SPC – unknown blood loss changed to known blood loss.

 

Under Administration:  Reference to Total Dose Infusion (TDI) has been removed.

 

Under Intravenous Bolus Injection:  the injectable dose is increased to up to 500 mg at 50 mg/min up to 3 times weekly.

 

Under Intravenous Drip Infusion:  doses ≤ 1000 mg may be infused over 30 minutes - higher doses still require 60 minutes infusion time.

 

Section 4.6  Change of title to Fertility, pregnancy and lactation.

 

Section 10  Date of revision changed to July 1, 2013.

Updated on 07/01/2013 and displayed until 10/07/2013
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Iron (III) isomaltoside 1000