Ocrevus
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
13-04-2023
Svojstava lijeka
(SPC)
13-04-2023
Izvješće o ocjeni javnog
(PAR)
25-01-2018
Aktivni sastojci:
ocrelizumab
Dostupno od:
Roche Registration GmbH
ATC koda:
L04AA
INN (International ime):
ocrelizumab
Terapijska grupa:
Immunosuppressants
Područje terapije:
Multiple Sclerosis
Terapijske indikacije:
Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.Treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
Proizvod sažetak:
Revision: 18
Status autorizacije:
Authorised
Datum autorizacije:
2018-01-08
Uputa o lijeku
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OCREVUS 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
ocrelizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet.You may need to read it again.
•
If you have any further questions, ask your doctor.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ocrevus is and what it is used for
2.
What you need to know before you are given Ocrevus
3.
How Ocrevus is given
4.
Possible side effects
5.
How to store Ocrevus
6.
Contents of the pack and other information
1.
WHAT OCREVUS IS AND WHAT IT IS USED FOR
WHAT OCREVUS IS
Ocrevus contains the active substance ‘ocrelizumab’. It is a type
of protein called a ‘monoclonal
antibody’. Antibodies work by attaching to specific targets in your
body.
WHAT OCREVUS IS USED FOR
Ocrevus is used to treat adults with:
•
Relapsing forms of multiple sclerosis (RMS)
•
Early primary progressive multiple sclerosis (PPMS)
WHAT IS MULTIPLE SCLEROSIS
Multiple Sclerosis (MS) affects the central nervous system, especially
the nerves in the brain and
spinal cord. In MS, the immune system (the body’s defence system)
works incorrectly and attacks a
protective layer (called myelin sheath) around nerve cells and causes
inflammation. Breakdown of the
myelin sheath stops the nerves working properly.
Symptoms of MS depend on which part of the central nervous system is
affected and can include
problems with walking and balance, weakness, numbness, double vision
and blurring, poor
coordination and bladder problems.
•
IN RELAPSING FORMS OF MS,
the patient has
repeated attacks of symptoms (relapses). The
symptoms can appear suddenly within a few hours, or slowly over
several days. The symptoms
disappear or improve between relapses but damage may build up and lead
to permanent
disability.
•
IN PRIMARY PROGR
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Ocrevus 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 300 mg of ocrelizumab in 10 mL at a concentration
of 30 mg/mL. The final drug
concentration after dilution is approximately 1.2 mg/mL.
Ocrelizumab is a humanised monoclonal antibody produced in Chinese
Hamster Ovary cells by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear to slightly opalescent, and colourless to pale brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ocrevus is indicated for the treatment of adult patients with
relapsing forms of multiple sclerosis
(RMS) with active disease defined by clinical or imaging features (see
section 5.1).
Ocrevus is indicated for the treatment of adult patients with early
primary progressive multiple
sclerosis (PPMS) in terms of disease duration and level of disability,
and with imaging features
characteristic of inflammatory activity (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by specialised physicians
experienced in the diagnosis
and treatment of neurological conditions and who have access to
appropriate medical support to
manage severe reactions such as serious infusion-related reactions
(IRRs).
Premedication for infusion-related reactions
The following two premedications must be administered prior to each
ocrelizumab infusion to reduce
the frequency and severity of IRRs (see section 4.4 for additional
steps to reduce IRRs):
•
100 mg intravenous methylprednisolone (or an equivalent) approximately
30 minutes prior to
each infusion;
•
antihistamine approximately 30-60 minutes prior to each infusion;
In addition, premedication with an antipyretic (e.g., paracetamol) may
also be considered
approximately 30-60 minutes prior to each infusion.
Posology
_Initial dose _
_ _
The initial 600 mg dose
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