‫רופא‬
‫בעלון ללרופא‬
‫בטיחות) בעלון‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
_January 24, 2013______________________ ‫תאריך‬
RECOMBINATE Powder and Solvent ‫שם תכשיר באנגלית‬
for Solution for Injection
250IU/10ml: 143 82 31871 00, 500IU/10ml: 143 83 31872 00; _‫מספר רישום‬
_1000IU/10ml: 143 84 31873 00
Teva Medical (Marketing) Ltd., Haorgim St 8, Ashdod 77100 ‫שם בעל הרישום‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
Special Warnings
and Special
Precautions for
Use
Contraindications
Paediatric population
The warnings and precautions for use in paediatric
patients do not differ from those for adult patients.
MedDRA
System
Organ
Class
Infections
and
infestations
Blood and
lymphatic
system
disorders
Immune
system
disorders
Nervous
system
disorders
Frequency
MedDRA
Preferred Term
uncommon
Ear infection
common
not known
uncommon
not known
Cardiac
disorders
Vascular
disorders
Respiratory,
thoracic and
mediastinal
disorders
not known
uncommon
uncommon
not known
Factor VIII
inhibition1
Anaphylactic
reaction shock
Hypersensitivity2
Dizziness
Tremor
Loss of
consciousness
Syncope
Headache
Paraesthesia
Cyanosis
Tachycardia
Epistaxis
Flushing
Haematoma
Hypotension
Pallor
Peripheral
coldness
Pharyngolaryngeal
pain
Dyspnea
MedDRA
System Organ
Class
Infections and
infestations
Blood and
lymphatic
system
disorders
Immune
system
disorders
Nervous
system
disorders
Frequency
MedDRA
Preferred Term
uncommon
Ear infection
common
Factor VIII
inhibition1
not known
Anaphylactic
shock
Hypersensitivity2
Dizziness
Tremor
uncommon
not known
Cardiac
disorders
Vascular
disorders
not known
Respiratory,
thoracic and
mediastinal
disorders
uncommon
uncommon
not known
Gastrointestinal
disorders
uncommon
Syncope
Headache
Cyanosis
Tachycardia
Epistaxis
Flushing
Haematoma
Hypotension
Pallor
Peripheral
coldness
Pharyngolaryngeal
pain
Dyspnea
Cough
Chest discomfort
Wheezing
Nausea
Adverse events
Cough
Chest discomfort
Wheezing
Gastrointestinal
disorders
Skin and
subcutaneous
tissue disorders
uncommon
Nausea
not known
Vomiting
Abdominal
pain
discomfort
Hyperhydrosis
Pruritus
Rash
Rash maculopapular
angiooedema
Urticaria
Skin
exfoliation
Erythema
Pain in
extremity
uncommon
not known
Musculoskeletal
and connective
tissue disorders
General
disorders and
administration
site conditions
uncommon
common
Chills
uncommon
Fatigue
Pyrexia
Malaise
Injection site
reactions
Chest pain
Chest
discomfort
Acoustic
stimulation
tests abnormal
not known
Investigations
uncommon
Skin and
subcutaneous
tissue disorders
not known
Vomiting
Abdominal
discomfort
uncommon
Hyperhydrosis
Pruritus
Rash
Rash maculopapular
Urticaria
Skin exfoliation
not known
Musculoskeletal
and connective
tissue disorders
General
disorders and
administration
site conditions
Investigations
uncommon
Pain in extremity
common
Chills
uncommon
Fatigue
Pyrexia
Acoustic
stimulation tests
abnormal
uncommon
Paediatric population
Other than the development of inhibitors in
previously untreated paediatric patients (PUPs), no
age-specific differences in ADRs were noted in the
clinical studies.
Drug Interactions
Recombinate is appropriate for the use in children of
all ages, including the newborn (safety and efficacy
studies have been performed in both previously
treated and previously untreated children; see section
5.1).
Recombinate is appropriate for the use in children of all
ages, including the newborn (safety and efficacy studies
have been performed in both previously treated and
previously untreated children; see section 5.1).
For long term prophylaxis against bleeding in
patients with severe haemophilia A, the usual doses
are 20 to 40 IU of factor VIII per kg body weight at
intervals of 2 to 3 days. In some cases, especially in
younger patients, shorter dosage intervals or higher
doses may be necessary.
For long term prophylaxis against bleeding in patients
with severe haemophilia A, the usual doses are 20 to
40 IU of factor VIII per kg body weight at intervals of 2
to 3 days. In some cases, especially in younger patients,
shorter dosage intervals or higher doses may be
necessary.
Paediatric population:
Recombinate is appropriate for the use in children of
all ages, including the newborn (Safety and efficacy
Posology
and
Method
of
Administration
studies have been performed in both previously
treated and previously untreated children; see section
5.1). For on-demand treatment, dosing in paediatric
patients does not differ from adult patients. For long
term prophylaxis against bleeding in patients with
severe haemophilia A, in some cases shorter dosage
intervals or higher doses may be necessary than the
usual doses of 20 to 40 IU of factor VIII per kg body
weight at intervals of 2 to 3 days.
For instructions on reconstitution of the medicinal
product before administration, see section 6.6.
Pregnancy
Lactation
Other
and