Betaferon 250 microgram/ml, powder and solvent for solution for injection

  • Name:

    Betaferon 250 microgram/ml, powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Interferon beta-1b

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/07/18

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Summary of Product Characteristics last updated on medicines.ie: 19/7/2018

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Bayer Limited

Bayer Limited

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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 20 July 2018 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 19 July 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

Section 2 - addition of the following: * produced by genetic engineering from strain of Escherichia coli.

Section 4.4 - Excipient warning:

Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

Minor Editorial changes have been made to section 5.1 & 5.2

 

Updated on 3 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 October 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 3 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 August 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

In section 7, the Marketing Authorisation Holder has changed from 'Bayer Pharma AG, D-13342 Berlin, Germany' to 'Bayer AG, 51368 Leverkusen, Germany'.

Updated on 31 July 2017 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 4 April 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder
  • Correction of spelling/typing errors

Updated on 2 November 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

In section 4.8:

The table 2: Adverse drug reactions has had the following additions:

 

System Organ Class

 

Very common

(³ 1/10) 1

Common

( ³ 1/100 to

< 1/10) 1

Uncommon

(³ 1/1,000 to

< 1/100) 1

Rare

( ³ 1/10,000 to < 1/1,000) 1

Frequency

not known

Respiratory, thoracic and mediastinal disorders

 

 

 

Bronchospasm2

Pulmonary arterial hypertension4

Gastrointestinal disorders

 

 

 

Pancreatitis

 

Hepatobiliary disorders

 

Blood bilirubin increased

Gamma-glutamyl-transferase increased,

Hepatitis

Hepatic injury (including hepatitis), Hepatic failure2

 

Skin and subcutaneous tissue disorders

 

Urticaria,

Pruritus,

Alopecia

Skin discolouration

 

 

Musculoskeletal and connective tissue disorders

Arthralgia

 

 

 

Drug-induced lupus erythematosus

4 Class label for interferon products, see below Pulmonary arterial hypertension.

The following paragraph has also been added to the same section:

Pulmonary arterial hypertension

Cases of pulmonary arterial hypertension (PAH) have been reported with interferon beta products. Events were reported at various time points including up to several years after starting treatment with interferon beta.

 

Updated on 11 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 11 September 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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

 

Thrombotic microangiopathy (TMA)

Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products. Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta. Early clinical features include thrombocytopenia, new onset hypertension, fever, central nervous system symptoms (e.g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film. Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended. If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Betaferon is recommended.

 

 

4.8     Undesirable effects

 

Table 2: Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies - where known - calculated based on pooled clinical trial data N= 1093)

System Organ Class

 

Very common

(³ 1/10) 1

Common

( ³ 1/100 to

< 1/10) 1

Uncommon

(³ 1/1,000 to

< 1/100) 1

Rare

( ³ 1/10,000 to < 1/1,000) 1

Frequency

not known

Blood and lymphatic system disorders

 

Anaemia

Thrombocytopenia

Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/ haemolytic uraemic syndrome3

 

1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000).

2 ADRs derived only during post-marketing

3 Class label for interferon beta products (see section 4.4).

 

 

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax; +353 1 6762517. Website: www.imb.iewww.hpra.ie; Ee-mail: imbpharmacovigilance@imb.iemedsafety@hpra.ie.

 

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Clinical efficacy and safety

 

SP-MS

 

From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS >1 point or >0.5 point for EDSS >=6 in the previous two years) can help to identify patients with active disease.

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of excipients:

 

Vial (with powder for solution forand injection):

Human albumin

Mannitol

 

 

10.     DATE OF REVISION OF TEXT

 

Augustpril 2014

 

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

 

Updated on 10 June 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

Posology

Paediatric population(Children and adolescents)

 

age. and t Therefore Betaferon should not be used in this population.

 

 

Method of administration

 

For subcutaneous injection.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

 

 

4.3     Contraindications

 

-               Initiation of treatment in pregnancy (see section 4.6 Pregnancy and lactation).

-               Patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin or to any of the excipients listed in section 6.1.

-               Patients with current severe depression and/or suicidal ideation (see sections 4.4 Special warnings and special precautions for use and 4.8Undesirable effects).

-               Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).

 

4.4     Special warnings and precautions for use

Nervous system disorders

Betaferon and treated appropriately. Cessation of therapy with Betaferon should be considered (see also sections 4.3 and section 4.8).

 

Betaferon should be administered with caution to patients with a history of seizures and to those receiving treatment with anti-epileptics, particularly if their epilepsy is not adequately controlled with anti-epileptics (see sections 4.5 and section  4.8).

 

 

Hepatobiliary disorders

 

As for other beta interferons, severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients treated withtaking Betaferon.

Nephrotic Syndrome

Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products. Events were reported at various time points during treatment and may occur after several years of treatment with interferon-beta. Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease. Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with Betaferon should be considered.

 

4.6     Pregnancy and breast-feeding lactation

Women of child-bearing potential should take appropriate contraceptive measures. If the patient becomes pregnant or plans to become pregnant while usingtaking Betaferon, she should be informed of the potential hazards and discontinuation of therapy should be considered (see section 5.3). In patients with a high relapse rate before initiation of treatmentstarted, the risk of a severe relapse following discontinuation of Betaferon in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.

 

Breast-feeding Lactation

 

 

where known - calculated based on pooled clinical trial data N= 1093)

System Organ Class

 

 

Very common

(³ 1/10) 1

Common

( ³ 1/100 to

< 1/10) 1

Uncommon

(³ 1/1,000 to

< 1/100) 1

Rare

( ³ 1/10,000 to < 1/1,000) 1

 

Frequency

not known

Blood and lymphatic system disorders

 

Anaemia

Thrombocytopenia

 

 

Immune system disorders

 

 

 

Anaphylactic reactions

Capillary leak syndrome in pre-existing monoclonal gammopathy2

Endocrine disorders

 

Hypothyroidism

 

Hyperthyroidism,

Thyroid disorders

 

Metabolism and nutrition disorders

 

Weight increased,

Weight decreased

Blood triglycerides increased

Anorexia2

 

Psychiatric disorders

 

Confusional state

 

Suicide attempt (see also section 4.4),

Emotional lability

 

 

Nervous system disorders

 

 

Convulsion

 

 

 

Cardiac disorders

 

Tachycardia

 

Cardiomyopathy2

 

 

Endocrine disorders

 

Hypothyroidism

 

Hyperthyroidism Thyroid disorders

 

Respiratory, thoracic and mediastinal disorders

 

 

 

Bronchospasm2

 

Gastrointestinal disorders

 

 

 

Pancreatitis

 

Hepatobiliary disorders

 

Blood bilirubin increased

Gamma-glutamyl-transferase increased,

Hepatitis

Hepatic injury (including hepatitis), Hepatic failure2

 

Immune system disorders

 

 

 

Anaphylactic reactions

Capillary leak syndrome in pre exisiting monoclonal gammopathy

Skin and subcutaneous tissue disorders

 

Urticaria,

Pruritus,

Alopecia

Skin discolouration

 

 

 

Musculoskeletal and connective tissue and bone disorders

Arthralgia

 

 

 

 

 

Renal and urinary disorders

 

 

Nephrotic syndrome, glomerulosclerosis (see section 4.4 )2

 

 

Nervous system disorders

 

 

Convulsion

 

 

Psychiatric disorders

 

Confusional state

Suicide attempt (see also section 4.4) Emotional lability

 

 

Reproductive system and breast disorders

 

Menorrhagia

 

 

 

 

 

Respiratory, thoracic and mediastinal disorders

 

 

Bronchospasm

 

 

Skin and subcutaneous tissue disorders

 

Urticaria, Pruritus,

Alopecia

Skin discoloration

 

 

1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000).

2 ADRs derived only during post-marketing

 

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

 

Description of selected adverse reactions

 

Cases of nephrotic syndrome and glomerulosclerosis have been reported during interferon beta treatment (see section 4.4).

 

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

 

5.1     Pharmacodynamic properties

Mechanism of action

 

Clinical efficacy and safetytrials

 

 

6.2     Incompatibilities

 

This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.

 

6.4     Special precautions for storage

 

For storage conditions of the reconstituted medicinal product, see section 6.3.

 

6.6     Special precautions for disposal and other handling

Dosage and administration

 

Disposal

 

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

10.     DATE OF REVISION OF TEXT

 

May 2012 April 2014

Updated on 27 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 16 April 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 18 June 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • 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

(Inserted text; deleted text)

 


4.8          Undesirable effects

…………………………….

b)            The following adverse event listing is based on reports from clinical trials (Table 1, adverse events and laboratory abnormalities) and from the post marketing surveillance (Table 2, frequencies – where known- based on pooled clinical trials ((very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000) reporting rates based on spontaneous adverse drug reaction reports classified as very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000) of Betaferon use. Experience with Betaferon in patients with MS is limited, consequently those adverse events which occur very rarely may not yet have been observed.

 

Table 1 (aAdverse events and laboratory abnormalities with incidence rates 10% and the respective percentages under placebo; significantly associated side effects < 10% based on reports from clinical trials).

 

<>

System Organ Class

 

Adverse Event

and

Laboratory Abnormalities

 

Single Event suggestive of Multiple Sclerosis

(BENEFIT) #

Secondary Progressive Multiple Sclerosis

(European Study)

Secondary Progressive Multiple Sclerosis

(North American Study)

Relapsing Remitting Multiple Sclerosis

Betaferon

250 microgram (Placebo)

n=292 (n=176)

Betaferon

250 microgram (Placebo)

n=360 (n=358)

Betaferon

250 microgram (Placebo)

n=317 (n=308)

Betaferon

250 microgram (Placebo)

n=124 (n=123)

 


The following updates have also been made to section 4.8:

BEFORE:


Table 2
(reporting rates (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000) based on spontaneous adverse drug reaction reports).

 

System Organ Class

 

 

Very common

³ 1/10

Common

 ³ 1/100 to

< 1/10

Uncommon

³ 1/1,000 to

< 1/100

Rare

 ³ 1/10,000 to < 1/1,000

 

Blood and lymphatic system disorders

 

 

Anaemia,

Thrombocytopenia,

Leukopenia

Lymphadenopathy

Immune system disorders

 

 

 

Anaphylactic reactions

Endocrine disorders

 

 

 

Hyperthyroidism,

Hypothyroidism,

Thyroid disorder

Metabolism and nutrition disorders

 

 

 

Blood triglycerides increased

Anorexia

Psychiatric disorders

 

 

Depression (see also section 4.4)

 

Confusion,

Anxiety,

Emotional lability,

Suicide attempt (see also section 4.4)

Nervous system disorders

 

 

 

 

Convulsion

Cardiac disorders

 

 

 

Cardiomyopathy,

Tachycardia, Palpitation

Vascular disorders

 

 

Hypertension

 

Respiratory, thoracic and mediastinal disorders

 

 

 

Bronchospasm, Dyspnoea

Gastrointestinal disorders

 

 

Vomiting,

Nausea

Pancreatitis

Hepatobiliary disorders

 

 

Alanine amino-transferase increased,

Aspartate amino-transferase increased

Blood bilirubin increased,

Gamma-glutamyl-transferase increased,

Hepatitis

Skin and subcutaneous tissue disorders

 

 

Urticaria,

Rash,

Pruritus,

Alopecia

Skin discolouration

Musculoskeletal, connective tissue and bone disorders

 

 

Myalgia,

Hypertonia

 

Reproductive system and breast disorders

 

 

 

Menstrual disorder

General disorders and administration site conditions

Flu-like symptoms*,

Chills*,

Fever*,

Injection site reaction*,

Injection site inflammation*,

Injection site pain

Injection site necrosis*

 

Chest pain, Malaise,

Sweating

Investigations

 

 

 

Weight decrease

* frequencies based on clinical trials

 

 

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

 

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

 

AFTER:


Table 2:
Adverse drug reactions (ADRs) identified during post-marketing surveillance (frequencies - where known - calculated based on pooled clinical trial data N= 1093)

System Organ Class

 

 

Very common

(³ 1/10) 1

Common

( ³ 1/100 to

< 1/10) 1

Uncommon

(³ 1/1,000 to

< 1/100) 1

Rare

( ³ 1/10,000 to < 1/1,000) 1

 

Frequency

Not known

Blood and lymphatic system disorders

 

Anaemia

Thrombocytopenia

 

 

Cardiac disorders

 

Tachycardia

 

Cardiomyopathy2

 

 

Endocrine disorders

 

Hypothyroidism

 

Hyperthyroidism,

Thyroid disorders

 

Gastrointestinal disorders

 

 

 

Pancreatitis

 

Hepatobiliary disorders

 

Blood bilirubin increased

Gamma-glutamyl-transferase increased,

Hepatitis

Hepatic injury (including hepatitis), Hepatic failure2

 

Immune system disorders

 

 

 

Anaphylactic reactions

Capillary leak syndrome in pre-existing monoclonal gammopathy2

Metabolism and nutrition disorders

 

Weight increased,

Weight decreased

Blood triglycerides increased

Anorexia2

 

Musculoskeletal, connective tissue and bone disorders

Arthralgia

 

 

 

 

 

Nervous system disorders

 

 

Convulsion

 

 

 

Psychiatric disorders

 

Confusional state

 

Suicide attempt (see also section 4.4),

Emotional lability

 

 

Reproductive system and breast disorders

 

Menorrhagia

 

 

 

Respiratory, thoracic and mediastinal disorders

 

 

 

Bronchospasm2

 

Skin and subcutaneous tissue disorders

 

Urticaria,

Pruritus,

Alopecia

Skin discolouration

 

 

 

1 frequencies based on pooled clinical trials (very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to < 1/100, rare ≥1/10,000 to <1/1,000, very rare < 1/10,000).

2 ADRs derived only during post-marketing.

 

The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.

 

 

5.1     Pharmacodynamic properties

 

TableABLE 3 Primary efficacy results of the BENEFIT and the BENEFIT Follow-up study

 

10.     DATE OF REVISION OF TEXT

 

July 2012May 2012

 

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

 

 

 

 

 

Updated on 1 June 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Correction of spelling/typing errors

Updated on 27 September 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

In section 7 (Marketing Authorisation Holder), the name of the marketing authorisation holder has been changed from "Bayer Schering Pharma AG" to "Bayer Pharma AG".

In section 10, the date of revision of the text has been changed to "July 2011".

Updated on 19 September 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 11 January 2011 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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

6.5     Nature and contents of container

 

Addition of:

 

"_               Pack with 12 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or

-               2-month pack with 2x14 single packs, each containing 1 vial with powder, 1 pre-filled syringe with solvent, 1 vial adapter with needle, 2 alcohol wipes or"

8.       MARKETING AUTHORISATION NUMBERS

Addition of:
"EU/1/95/003/011

EU/1/95/003/012"

10.     DATE OF REVISION OF TEXT

 

 

Changed to: "December 2010"

Updated on 5 January 2011 PIL

Reasons for updating

  • Change to MA holder contact details
  • Introduction of new pack/pack size

Updated on 2 March 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details
  • Correction of spelling/typing errors

Updated on 18 February 2010 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic 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

Addition of data from the Benefit five year study to section 4.8 and 5.1.

Updated on 22 April 2008 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Change to improve clarity and readability

Updated on 25 February 2008 PIL

Reasons for updating

  • Change to side-effects
  • Correction of spelling/typing errors
  • Change to further information section
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to improve clarity and readability

Updated on 21 February 2008 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 Posology and method of administration

 

In the third final paragraph of the section the text was changed from “….efficacy has been demonstrated over a period of two years.” to “….efficacy has been demonstrated over a period of three years.”

 

Section 4.4 Special warnings and precautions for use

 

In the section entitled “Immunogenicity” the text was changed from “In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at the respective visits in between 16.5 and 25.2% of Betaferon treated patients. Neutralising activity was found at least once in 30% (75) of the Betaferon treated patients; of these, 23% (17) returned to negative status before reaching the end of the study. Within the study period of two years, the development of neutralising activity was not associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS)).” to “In the study of patients with a single clinical event suggestive of multiple sclerosis, neutralising activity measured every 6 months was observed at least once in 32% (88) of the patients treated immediately with Betaferon; of these, 47% (41) returned to negative status over a 3 year period. Within this period, the development of neutralizing activity was not associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), and time to confirmed EDSS progression).”

 

Section 4.8 Undesirable effects

 

§         The headings in Table 1 were changed from;

System Organ Class

 

Adverse Event

and

Laboratory Abnormalities

Single Event suggestive of Multiple Sclerosis (BENEFIT)

 

 

 

 

Secondary Progressive Multiple Sclerosis

(European Study)

Secondary Progressive Multiple Sclerosis

(North American Study)

Relapsing Remitting Multiple Sclerosis

Betaferon

250 microgram (Placebo)

n = 292

(n = 176)

Betaferon

250 microgram (Placebo)

n=360

(n=358)

Betaferon

250 microgram (Placebo)

n=317

(n=308)

Betaferon

250 microgram (Placebo)

n=124

(n=123)

 

To;

System Organ Class

 

Adverse Event

and

Laboratory Abnormalities

Single Event suggestive of Multiple Sclerosis (BENEFIT)#

 

 

 

 

Secondary Progressive Multiple Sclerosis

(European Study)

Secondary Progressive Multiple Sclerosis

(North American Study)

Relapsing Remitting Multiple Sclerosis

Betaferon

250 microgram (Placebo)

n = 292

(n = 176)

Betaferon

250 microgram (Placebo)

n=360

(n=358)

Betaferon

250 microgram (Placebo)

n=317

(n=308)

Betaferon

250 microgram (Placebo)

n=124

(n=123)

 

§         There was also a change to the key for Table 1. The following text was inserted; “# During the third year of the BENEFIT study, no change of the known risk profile of Betaferon was observed.”

 

Section 5.1 Pharmacodynamic properties

 

§         In the section entitled “Single clinical event suggestive of MS:” The following text was inserted between the first and second paragraph tying the two paragraphs together; “This study consisted of two phases, a placebo-controlled phase followed by a pre-planned follow-up phase. The placebo-controlled phase lasted for 2 years or until the patient developed clinically definite multiple sclerosis (CDMS), whichever came first. After the placebo-controlled phase, patient entered a pre-planned follow-up phase with Betaferon to evaluate the effects of immediate versus delayed start of Betaferon treatment, comparing patients initially randomized to Betaferon ("immediate treatment group") or to placebo ("delayed treatment group"). Patients and investigators remained blinded to the initial treatment allocation. In the placebo-controlled phase, Betaferon delayed….”

 

§         The following text was inserted at the end of the new first paragraph; “This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (Hazard Ratio = 0.59, 95% confidence interval (0.42, 0.83), p = 0.0011).Within the study period of three years, CDMS occurred in 51% of the delayed treatment group compared to 37% of the immediate treatment group (Kaplan-Meier estimates). The persistence of the treatment effect was observed although the majority of patients from the placebo-group was treated with Betaferon in the third year of the study.”

 

§         A new third paragraph was inserted; “After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard ratio=0.6, 95% confidence interval (0.39, 0.92), p=0.022]. There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving 'immediate' treatment. Follow-up of patients is continuing in order to provide additional data. No benefit, attributable to Betaferon, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.”

 

§         The title “RR-MS, SP-MS and single clinical event suggestive of MS:” was inserted above the final paragraph of this section.

 

Section 6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

The section entitled “Reconstitution” was changed from “To reconstitute lyophilised interferon beta-1b for injection, use the pre-filled syringe with solvent provided and a needle to inject 1.2 ml of the solvent (sodium chloride solution, 5.4mg/ml (0.54% w/v)) into the Betaferon vial. Dissolve the powder completely without shaking.

After reconstitution, draw 1.0ml from the vial into the syringe for the administration of 250 micrograms Betaferon.” To “To reconstitute lyophilised interferon beta-1b for injection, connect the vial adapter with attached needle to the vial. Connect the pre-filled syringe with solvent to the vial adapter and inject the 1.2 ml of the solvent (sodium chloride solution, 5.4mg/ml (0.54% w/v)) into the Betaferon vial. Dissolve the powder completely without shaking.

After reconstitution, draw 1.0ml from the vial into the syringe for the administration of 250 micrograms Betaferon.

Remove the vial with the vial adapter from the pre-filled syringe before injection.”

 

Section 10. Date of revision of the text

 

The date was changed from “March 2007” to “December 2007”

Updated on 30 July 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to name of manufacturer
  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 12 July 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • 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 CLINICAL PARTICULARS
4.2 Posology and method of administration
 
The heading has been changed from ‘Adult patients (≥18 years)’ to ‘Adults’

 The following text has been inserted;

‘Children and adolescents:
 
No formal clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 16 years of age receiving Betaferon 8.0 million IU subcutaneously every other day is similar to that seen in adults. There is no information on the use of Betaferon in children under 12 years of age and therefore Betaferon should not be used in this population.

 The following text has been deleted:

Children and adolescents(<18 years)

Betaferon is not recommended for use in children below 18 years of age due to insufficient data on safety and efficacy.

 Section 5. PHARMACOLOGICAL PROPERTIES

5.1     Pharmacodynamic properties

Heading, Clinical trials; Sub-heading, Single clinical event suggestive of MS:

The text has been changed from;

‘…in a highly statistically significant and clinically meaningful manner,…’

to;

‘…in a statistically significant and clinically meaningful manner,…

 Section 7. MARKETING AUTHORISATION HOLDER

The text has been changed from ‚Schering Aktiengesellschaft’ to ‚Bayer Schering Pharma AG’

 Section 10. DATE OF REVISION OF TEXT

The text has been changed from ’September 2006’ to ‘March 2007’

Updated on 12 October 2006 PIL

Reasons for updating

  • Change to further information section

Updated on 12 October 2006 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Main changes to the SPC include:

 

SECTION 6.5 NATURE AND CONTENTS OF CONTAINER

Updated description of Betaferon vials and pre-filled solvent syringes.

 

SECTION 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

Precautions for handling now categorized under the following headings:

  • Reconstitution
  • Inspection Prior to Use
  • Disposal

 

Updated on 23 June 2006 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 4.3 - 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 5.3 - Preclinical safety data
  • 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

Main changes to the SPC include:

 

SECTION 4.1 THERAPEUTIC INDICATIONS

New indication: Treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

 

SECTION 4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Details of recommended slow upward titration of dose upon initiation of treatment.

Updated exposure and efficacy data.

 

SECTION 4.3 CONTRAINDICATIONS

Deletion of a contraindication: ‘patients with epilepsy not adequately controlled by treatment’.

Change from contraindication in patients with 'history of severe depressive disorders and/or suicidal ideation' to patients with 'current severe depression and/or suicidal ideation'. 

 

SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Section reformatted: precautions and warnings presented categorised under body system.

Changes to the following sections:         Nervous system disorders

                                                            Laboratory Test

                                                            Cardiac disorders

                                                            General disorders and administration site conditions

                                                            Immunogenicity

 

SECTION 4.6 PREGNANCY AND LACTATION

Additional information regarding the use of Betaferon in pregnancy and in women of child-bearing age.

 

SECTION 4.8 UNDESIRABLE EFFECTS

Table 1: Addition of details of adverse events observed in the ‘BENEFIT’ study (study examining use of Betaferon in single event suggestive of MS).

Table 2: Updated data regarding adverse events reported from the market.

 

SECTION 5.1 PHARMACODYNAMIC PROPERTIES

Updated ATC code.

Addition of clinical trial data obtained from the ‘BENEFIT’ study (study examining use of Betaferon in single event suggestive of MS).

                                                                     

Updated on 23 June 2006 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to how the medicine works

Updated on 14 February 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to side-effects

Updated on 8 February 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 26 October 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 July 2004 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

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

Updated on 15 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 2 July 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 11 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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