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^Rebif44gX3.
Interferon beta-1a
Life Goes On...
REBIF® 22 MICROGRAMS and REBIF® 44 MICROGRAMS - solution for
injection: Interferon beta-1a (for subcutaneous injection). Presentation: A
pre-filled syringe containing 22 micro-grams (6 million IU) in 0.5 ml or 44
micrograms (12 million IU) of interferon beta-1a in 0.5 ml. Indications: For the
treatment of ambulatory patients with relapsing-remitting multiple sclerosis (MS)
characterised by at least 2 recurrent attacks of neurological dysfunction (relapses)
over the preceding 2-year period. Rebif decreases the frequency and severity of
relapses over 4 years, and slows the progression of disability. Rebif has not yet
been investigated in patients with progressive multiple sderosis, and should be
discontinued in patients who develop progressive multiple sderosis. Dosage and
administration: The recommended posology of Rebif 44 is 44 micrograms given
three times per week by subcutaneous injection. Rebif 22 micrograms, also given
three times per week by subcutaneous injection, is recommended for patients
who cannot tolerate the higher dose in the view of the treating specialist.
Treatment should be initiated under supervision of a physician experienced in the
treatment of the disease. When first starting treatment with Rebif, in order to
allow tachyphylaxis to develop thus reducing adverse events, it is recommended
that 8.8 micrograms (0.1 ml of the 44 micrograms strength or 0.2 ml of the 22
micrograms strength) be administered during the initial 2 weeks of therapy, 22
micrograms (0.25 ml of the 44 micrograms strength or the total of the 22
micrograms strength) be administered in weeks 3 and 4, and the total of the 44
micrograms strength be administered from the fifth week onwards. There is no
experience with Rebif in children under 16 years of age with multiple sderosis and
therefore Rebif should not be used in this population. It is recommended that
patients should be evaluated at least every second year in the 4 year period after
initiation of treatment with Rebif and a decision for longer-term treatment should
then be made on an individual basis by the treating physician. Contraindications:
Interferon beta-1a is contraindicated in patients with a known hypersensitivity to
natural or recombinant interferon beta, human serum albumin, or any other
component of the formulation. Interferon beta-1a is contraindicated in pregnant
patients, patients with severe depressive disorders and/or suicidal ideation, and in
epileptic patients with a history of seizures not adequately controlled by
treatment. Precautions: Patients should be informed of the most common
adverse events associated with interferon beta administration, including
symptoms of the flu-like syndrome (see 4.8 Undesirable effects). These symptoms
tend to be most prominent at the initiation of therapy and decrease in frequency
and severity with continued treatment. Interferons should be used with caution in
patients with depression. Patients treated with Interferon beta-1a should be
advised to immediately report any symptoms of depression and/or suicidal ideation
to their prescribing physician. Patients exhibiting depression should be monitored
closely during therapy with Interferon beta-1a and treated appropriately.
Cessation of therapy with Interferon beta-la should be considered. Caution
should be exercised when administering Interferon beta-1a to patients with pre-
existing seizure disorders. For patients without a pre-existing seizure disorder who
develop seizures during therapy with Interferon beta-1a, an aetiological basis
should be established and appropriate anti-convulsant therapy instituted prior to
resuming Interferon beta-1a treatment. Patients with cardiac disease, such as
angina, congestive heart failure or arrhythmia, should be closely monitored for
worsening of their dinical condition during initiation of therapy with Interferon
beta-1a. Laboratory abnormalities are associated with the use of interferons. The
overall incidence of these is slightly higher with Rebif 44 than Rebif 22
micrograms. Therefore, in addition to those laboratory tests, normally required for
monitoring patients with multiple sclerosis, complete and differential white blood
cell counts, platelet counts and blood chemistries, induding liver function tests are
recommended during Rebif therapy. Caution should be used, and dose
monitoring considered when administering Interferon beta-1a to patients with
severe renal and hepatic failure and to patients with severe myelosuppression.
Serum neutralising antibodies against Interferon beta-1a may develop. Clinical
data suggest that after 24 to 48 months of treatment with Rebif 44 micrograms,
approx. 13 to 14% of patients develop serum antibodies to Interferon beta-1a
(approx. 24% with Rebiff 22 micrograms). The precise incidence of antibodies ís a
yet uncertain and dinical significance is not fully elucidated but is associated with
reduced efficacy. If a patient responds poorly to therapy with Rebif, and has
neutralising antibodies, the treating physician should reassess the benefit/risk ratio
of continued Rebif therapy. Caution should be exercised when administering Rebif
in combination with medicinal products that have a narrow therapeutic index and
are largely dependent on the hepatic cytochrome P450 system for dearance, e.g.
antiepileptics and some classes of antidepressants. Clinical studies indicate that
multiple sderosis patients can receive Rebif and corticosteroids or ACTFI during
relapses. Rebif should not be administered in case of pregnancy and lactation.
Side-effects: The highest incidence of undesirable effects associated with the
interferon therapy is related to flu syndrome. Injection site reactions are commonly
encountered and are usually mild and reversible. Injection site necrosis has
uncommonly been reported. In all cases, the necrosis resolved spontaneously.
Other less common adverse events reported in association with interferon beta
include diarrhoea, anorexia, vomiting, insomnia, dizziness, anxiety, rash,
vasodilation and palpitation. The administration of type 1 interferons has rarely
been associated with serious CNS undesirable effects such as depression, suicide,
and depersonalisation as well as seizures and arrythmias. Hypersensitivity reartions
may occur. Pharmaceutical precautions: Store at 2-8°C in the original package.
Do not freeze. REBIF can, at the user, be stored beíow 25°C for up to 30 days and
used before the expiry date. Legal category: POM. Marketing authorisation
numbers: REBIF44 micro-grams EU/1/98/063/004 (1 syringe), EU/1/98/063/005 (3
syringes), EU/1/98/063/006 (12 syringes). MARKETING AUTHORISATION
HOLDER: SERONO (Europe) Ltd, 56, Marsh Wall, London, E14 9TP. United
Kingdom. Date of preparation: July 2001. Please refer to the Summary of
Product Chararteristics for further information.
Reference: 1. PRISMS Study Group (Hughes et al.). PRISMS-4: Long-term efficacy
of interferon-beta-1a in relapsing MS. Neurology 2001; 56:1628-36
Page
Program at a glance........................ 4
Welcome address............................ 5
Scientific program......................... 6
Social program............................ 17
Abstracts................................. 19
Posters................................... 39
Authors’Index............................. 50
General Information....................... 52
Map of Háskólabíó......................... 53
Exhibition................................ 54
Sponsors.................................. 54
The 33rd Scandinavian Neurology
Congress (SNC)
Organising Committee
Albert Páll Sigurðsson MD
Haukur Hjaltason MD, PhD
Ólöf Bjarnadóttir MD
Scientific Committee
Sigurlaug Sveinbjörnsdóttir, MD
Elías Ólafsson, MD, PhD
Einar Már Valdimarsson, MD
Grétar Guðmundsson, MD
The 2nd Scandinavian Congress of
Neurological Nursing (SCNN)
Organising Committee
Ingibjörg Sig. Kolbeins RN
Jónína Hallsdóttir RN
Jónína Hafliðadóttir RN
Ellen Þórarinsdóttir RN
Hafdís Gunnbjörnsdóttir RN
Kristín Rós Sigurðardóttir RN
Scientific Committee
Ásta St. Thoroddsen RN, MS
Helga Jónsdóttir, RN, PhD
Auöna Ágústsdóttir, RN, PhD
Congress Organizer
Congress Reykjavík
Engjateig 5
IS-105 Reykjavík
Tel.: +354 585 3900 - Fax: +354 585 3901
congress@congress.is
Ljósmynd á kápu
Úr Hornafirði: Páll Stefánsson
Læknablaðið/Fylgírit 43 2002/88 3