Mycamine 50 & 100 mg powder for solution for infusion

  • Name:

    Mycamine 50 & 100 mg powder for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Micafungin sodium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/02/19

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Summary of Product Characteristics last updated on medicines.ie: 26/2/2019

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Astellas Pharma Co. Ltd

Astellas Pharma Co

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Medicine Name Modigraf 0.2mg & 1mg granules for oral suspension Active Ingredients Tacrolimus Monohydrate
Medicine Name Mycamine 50 & 100 mg powder for solution for infusion Active Ingredients Micafungin sodium
Medicine Name Omnexel Active Ingredients Tamsulosin Hydrochloride
Medicine Name Prograf 0.5 mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf 1mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf 5mg Capsules Active Ingredients Tacrolimus Monohydrate
Medicine Name Prograf Concentrate for Infusion Active Ingredients Tacrolimus
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Medicine Name Vesitirim 10mg Film-coated Tablets Active Ingredients Solifenacin succinate
Medicine Name Vesitirim 5mg Film-Coated tablets Active Ingredients Solifenacin succinate
Medicine Name Vesomni 6 mg/0.4 mg modified release tablets Active Ingredients Solifenacin succinate, Tamsulosin Hydrochloride
Medicine Name Xtandi 40 mg soft capsules Active Ingredients enzalutamide
Medicine Name Zepholin SR 100mg Prolonged Release Capsules Active Ingredients Theophylline
Medicine Name Zepholin SR 200mg Prolonged Release Capsules Active Ingredients Theophylline
1 - 0 of 23 items.Total: Infinity pages

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 1 April 2019 Ed-HCP

Reasons for updating

  • Replace document

Updated on 26 February 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 26 February 2019 SmPC

Reasons for updating

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

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

Updated on 10 August 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 9 August 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 4 May 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 7 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 7 March 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

Bold text – new text

Strike-through text - deleted text

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

New headings: Mycamine 50& 100 mg

 4.1     Therapeutic indications

Consideration should be given to official/national guidance on the appropriate use of antifungal agents.

 

 4.2     Posology and method of administration

 

Consideration should be given to official/national guidance on the appropriate use of antifungal agents.

 

Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.

 

Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

 

Posology

Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

 

 

Oesophageal candidiasis: For the treatment of oesophageal candidiasis, micafungin Mycamine should be administered for at least one week after resolution of clinical signs and symptoms.

 

Prophylaxis of Candida infections: For prophylaxis of Candida infection, micafungin Mycamine should be administered for at least one week after neutrophil recovery.

 

Use in children (including neonates) < 4 months of age

 

*

Prophylaxis of Candida infections: For prophylaxis of Candida infection, micafungin Mycamine should be administered for at least one week after neutrophil recovery. Experience with Mycamine in patients less than 2 years of age is limited.

 

Gender/race

No dose adjustment is necessary based on gender or race (see section 5.2).

 

The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established. Currently available data are described in section 4.8, 5.1, 5.2.

 

 4.6     Fertility, pregnancy and lactation

 

Inclusion of Fertility in heading

 
4.7     Effects on ability to drive and use machines

 

Micafungin has no or negligible influence on the ability to drive or use machines. However, patients should be informed that dizziness has been reported during treatment with micafungin (see section 4.8).

 

No studies on the effects on the ability to drive and use machines have been performed. However, adverse reactions may occur, which may influence the ability to drive and use machines (see section 4.8).

 
4.8     Undesirable effects

 

Summary of the safety profile

The safety profile of micafungin is based on 3028 patients treated with micafungin in clinical studies: 2.002 patients with Candida infections (including candidaemia, invasive candidiasis and oesophageal candidiasis), 375 with invasive aspergillosis (primarily refractory infections) and 651 for prophylaxis of systemic fungal infections.

The patients treated with micafungin in clinical studies represent a critically ill patient population that requires multiple medicinal products including antineoplastic chemotherapy, potent systemic immunosuppressants and broad spectrum antibiotics. These patients had a wide variety of complex underlying conditions such as haematological malignancies and HIV-infection or were transplant recipients and/or treated in intensive care. Patients treated prophylactically with micafungin were those undergoing haematopoetic stem cell transplantation (HSCT) who were at high risk for fungal infections.

Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions. The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%). No clinically significant differences were seen when the safety data were analysed by gender or race.

 

 9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 25 April 2008

Date of latest renewal: 20 December 2012 19 February 2018

 

 10.     DATE OF REVISION OF THE TEXT

 

29 June 2016
19 February 2018

 

 

 

 

 

 

 

 

 

 

 

Updated on 27 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 February 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 15 July 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 July 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.9 - Overdose
  • 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

Section 4.2:

Information on dosing and instructions for use in children (including neonates) < 4 months has been added

Section 4.9:
Reported case of overdose in newborn patient added

Section 5.2:
Information on the pharmacokinetic properties in children less than 4 months has been added

Section 10:
Date of revision updated to 29 June 2016

Updated on 10 February 2016 SmPC

Reasons for updating

  • 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


5.2 Pharmacokinetic properties (text in bold added, strikethrough text deleted)

Special Populations

Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5 4 mg/kg. Clearance was influenced by weight, with mean values of weight-adjusted clearance 1.35 times higher in the younger children (4 months to 5 years) and 1.14 times higher in paediatric patients aged 6 to 11 years. Older children (12-16 years) had mean clearance values similar to those determined in adult patients.Clearance was influenced by age, with mean values of clearance in younger children (2 11 years) being approximately 1.3 fold greater than those in older children (12 17 years). Older children had mean clearance values similar to those determined in adult patients. Mean clearance in premature infants (gestational age approximately 26 weeks) is approximately 5 fold greater than in adults.

Date of revision of the text: 17-Dec-2015


Updated on 28 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 28 May 2015 SmPC

Reasons for updating

  • 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

The HPRA name has been updated in the section on reporting of side effects
The date of revision has been updated to May 2015

Updated on 4 January 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 3 January 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation
  • 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

4.8     Undesirable effects

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 online reporting option (preferable method) accessible from the IMB homepage (www.imb.ie).  A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.

 

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

 

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

PK/PD relationship

An additive or synergistic pharmacodynamic interaction of micafungin and amphotericin B was found in a mouse model of pulmonary aspergillosis (immunosuppression with hydrocortisone, intranasal infection with Aspergillus fumigatus)In animals models of candidiasis, a correlation was observed between exposure of micafungin divided by MIC (AUC/MIC) and efficacy defined as the ratio required to prevent progressive fungal growth. A ratio of ~2400 and ~1300 was required for C. albicans and C. glabrata, respectively, in these models. At the recommended therapeutic dosage of Mycamine, these ratios are achievable for the wild-type distribution of Candida spp.

 

Mechanism(s) of resistance

As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded. Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.

 

Breakpoints

Susceptibility testing was performed with modifications according to the Clinical and Laboratory Standards Institute (CLSI) methods M27‑A2 (Candida species) and M38‑A (Aspergillus species), respectively. To date, standardised techniques for susceptibility testing for 1,3‑b‑D‑glucan synthesis inhibitors have not been established and results of susceptibility testing do not necessarily correlate with clinical outcome.

 

Although no MIC breakpoints for echinocandins have been established, a MIC of < 2 mg/l encompasses > 99% of all clinical isolates of Candida spp. without bisecting any species group and represents a concentration that is easily maintained throughout the dosing interval. Infections due to Candida spp. in this MIC range are likely to respond to therapy.

 

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. This information is only a guide to the probabilities of whether micro-organisms will be susceptible to micafungin or not. Where applicable the information on the European range of acquired resistance for the individual micro-organisms is indicated in brackets.

 

Commonly susceptible species [MIC ranges in Europe, mg/l]

Candida albicans [0.007 - 0.25]

Candida glabrata [0.007 - 0.12]

Candida tropicalis [0.007 - 0.12]

Candida krusei [0.015 - 0.12]

Candida kefyr [0.03 - 0.06]

Candida parapsilosis [0.12 - 2]

Candida guilliermondii [0.5]

Candida lusitaniae [0.12 - 0.25]

Candida spp. [0.015 - 0.5]

(incl. C. famata, C. dubliniensis, C. lipolytica, C. pelliculosa, C. rugosa, C. stellatoidea and C. zeylanoides)

 

Aspergillus fumigatus

Aspergillus flavus

Aspergillus niger

Aspergillus terreus

Aspergillus nidulans

Aspergillus versicolor

 

The mycelial form of dimorphic fungi (e.g. Histoplasma capsulatum, Blastomyces dermatitidis, Coccidioides immitis)

 

Species for which acquired resistance may be a problem

None

 

Inherently resistant organisms

Cryptococcus spp.

Pseudallescheria spp.

Scedosporium spp.

Fusarium spp.

Trichosporon spp.

Zygomycetes spp.

 

EUCAST breakpoints

Candida species

MIC breakpoint (mg/L)

≤S (Susceptible)

>R (Resistant)

Candida albicans

0.016

0.016

Candida glabrata

0.03

0.03

Candida parapsilosis

0.002

2

Candida tropicalis 1

Insufficient evidence

Candida krusei1

Insufficient evidence

Candida guilliermondii1

Insufficient evidence

Other Candida spp.

Insufficient evidence

1 MICs for C. tropicalis are 1-2 two-fold dilution steps higher than for C  albicans and C. glabrata. In the clinical study, successful outcome was numerically slightly lower for C. tropicalis than for C. albicans at both dosages (100 and 150 mg daily). However, the difference was not significant and whether it translates into a relevant clinical difference is unknown. MICs for C. krusei are approximately 3 two-fold dilution steps higher than those for C. albicans and, similarly, those for C. guilliermondii are approximately 8 two-fold dilutions higher. In addition, only a small number of cases involved these species in the clinical trials. This means there is insufficient evidence to indicate whether the wild-type population of these pathogens can be considered susceptible to micafungin.

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 25 April 2008

Date of latest renewal: 20 December 2012

 

10.     DATE OF REVISION OF THE TEXT

 

12/2013

Updated on 1 October 2013 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 9 July 2013 SmPC

Reasons for updating

  • 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

correct date to 20 Decemeber 2012

Updated on 17 April 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Astellas Pharma Europe B.V.

Sylviusweg 62

2333 EB Leiden

Netherlands

Updated on 23 January 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

 

The following text has been deleted:

 

“This medicinal product for intravenous use contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.”

 

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of last renewal: 20th December 2012

 

All other changes made are in line with the QRD template.

Updated on 13 September 2011 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • 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

4.3     Contraindications

 

Hypersensitivity to the active substance, to other echinocandins or to any of the excipients.

 

 

During administration of micafungin, anaphylactic/anaphylactoid reactions including shock may occur. If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.

 

Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress.

 

 

4.8     Undesirable effects

 

 

System Organ Class

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Not known

(frequency cannot be estimated from available data)

Blood and lymphatic system disorders

leukopenia, neutropenia, anaemia

pancytopenia, thrombocytopenia, eosinophilia, hypoalbuminaemia

haemolytic anaemia, haemolysis (see section 4.4)

disseminated intravascular coagulation

Immune system disorders

 

anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity

 

 

Endocrine disorders

 

hyperhidrosis

 

 

Metabolism and nutritional disorders

hypokalaemia, hypomagnesaemia, hypocalcaemia

hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia

 

 

Psychiatric disorders

 

insomnia, anxiety, confusion

 

 

Nervous system disorders

headache

somnolence, tremor, dizziness, dysgeusia

 

 

Cardiac disorders

 

tachycardia, palpitations, bradycardia

 

 

Vascular disorders

phlebitis

hypotension, hypertension, flushing

 

shock

Respiratory, thoracic and mediastinal disorders

 

dyspnoea

 

 

Gastrointestinal disorders

nausea, vomiting, diarrhoea, abdominal pain

dyspepsia, constipation

 

 

Hepatobiliary disorders

blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal

hepatic failure (see section 4.4), gamma-glutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis

 

hepatocellular damage including fatal cases (see section 4.4)

Skin and subcutaneous tissue disorders

rash

urticaria, pruritus, erythema

 

toxic skin eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (see section 4.4)

Renal and urinary disorders

 

blood creatinine increased, blood urea increased, renal failure aggravated

 

renal impairment (see section 4.4), acute renal failure

General disorders and administration site conditions

pyrexia, rigors

injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema

 

 

Investigations

 

blood lactate dehydrogenase increased

 

 

 

Updated on 25 February 2011 PIL

Reasons for updating

  • Change to drug interactions

Updated on 23 February 2011 SmPC

Reasons for updating

  • 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 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

4.4     Special warnings and precautions for use

 

Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.5).

 

Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.5).

 

The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).

 

 

4.5     Interaction with other medicinal products and other forms of interaction

 

 

Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B. In these studies, no evidence of altered pharmacokinetics of micafungin was observed. No micafungin dose adjustments are necessary when these medicines are administered concomitantly. Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).

 

Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure. Since this may be of clinical significance this co-administration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4).

 

Patients receiving sirolimus, nifedipine or itraconazole in combination with Mycamine should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.4).

 

 

 

10.     DATE OF REVISION OF THE TEXT

 

December 2010

 

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.

Updated on 3 September 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to MA holder contact details

Updated on 17 August 2010 SmPC

Reasons for updating

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

Changes in Red

4.4     Special warnings and precautions for use

Micafungin may cause kidney problems, renal failure, and abnormal renal function test. Patients should be closely monitored for worsening of renal function.

 

Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.5).

 

10.     DATE OF REVISION OF THE TEXT

 

August  2010

Updated on 4 January 2010 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 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of renewal of authorisation
  • 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



Change detail Mycamine SPC

 

Version April 2009 versus November 2009

 

 

Section 4.2 Posology and method of administration.

 

Use in patients with hepatic impairment

There are currently no data available for the use of Mycamine in patients with severe hepatic impairment and its use is not recommended in these patients (see section 4.4).

 

Was updated to read:

 

There are currently insufficient data available for the use of Mycamine in patients with severe hepatic impairment and its use is not recommended in these patients (see section 4.4 and 5.2).

 

 

Section 4.4       Special warnings and precautions for use

Removed the following sentence:

There are insufficient data on the pharmacokinetics of micafungin in patients with severe hepatic impairment (see section 5.2).

 

Section 5.2       Pharmacokinetic properties

 

Deleted the following sentence: The pharmacokinetics of micafungin has not been studied in patients with severe hepatic insufficiency.

 

 

Inserted the following: In a study performed in patients with severe hepatic impairment (Child-Pugh score 10-12) (n=8), lower plasma concentrations of micafungin and higher plasma concentrations of the hydroxide metabolite (M-5) were seen compared to healthy subjects (n=8). These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.

 

Section  9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Removed: Date of first authorisation

 

Section 10.       DATE OF REVISION OF THE TEXT

 

Inserted 11/2009.

 

 

 

 

Updated on 31 March 2009 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

 
 
Section 4.4, in Hepatic effects paragraph correction of typos.
 
Section 7: MAH change from Munich Germany to Leiderdorp in the Netherlands.

Updated on 10 February 2009 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

 
 
Marketing Authorisation Holder updated from Astellas Pharma GmbH to Astellas Pharma Europe B.V.

Updated on 21 October 2008 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 August 2008 SmPC

Reasons for updating

  • New SPC for new product

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