ELIQUIS 2.5 MG

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

APIXABAN

Fáanlegur frá:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC númer:

B01AF02

Lyfjaform:

FILM COATED TABLETS

Samsetning:

APIXABAN 2.5 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

BRISTOL-MYERS SQUIBB S.R.L, ITALY

Meðferðarhópur:

APIXABAN

Lækningarsvæði:

APIXABAN

Ábendingar:

Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Leyfisdagur:

2017-05-31

Upplýsingar fylgiseðill

Эликвис
тм
Карточка пациента
по безопасному
применению
препарата
(Apixaban 2,5 мг, 5 мг)
9
8
7
ПРЕПАРАТЫ, ПРИНИМАЕМЫЕ ПАРАЛЛЕЛЬНО
CЛУЧАИ, ПРИ КОТОРЫХ ТРЕБУЕТСЯ
НЕЗАМЕДЛИТЕЛЬНОЕ ОБРАЩЕНИЕ К ВРАЧУ:
кровотечение, которое может угрожать
жизни. Аллергическая реакция,
включающая
сыпь, отек, отечность лица, губ,
полости рта,
языка и/или горла, затрудненное
дыхание
(редко).
ПОБОЧНЫЕ ЯВЛЕНИЯ
ВО ВРЕМЯ ПРИЕМА АНТИКОАГУЛЯНТА МОГУТ
ВОЗНИКАТЬ ПОБОЧНЫЕ ЯВЛЕНИЯ; О НИХ
СЛЕДУЕТ
ЗНАТЬ И ПРИ НЕОБХОДИМОСТИ ОБРАЩАТЬСЯ
ЗА
МЕДИЦИНСКОЙ ПОМОЩЬЮ. ПОЛНЫЙ СПИСОК
ПОБОЧНЫХ ЯВЛЕНИЙ ПРИВОДИТСЯ В
ИНСТРУКЦИИ
ПО ПРИМЕНЕНИЮ ПРЕПАРАТА. САМЫМ ЧАСТЫМ
ПОБОЧНЫМ ЯВЛЕНИЕМ ЯВЛЯЕТСЯ
КРОВОТЕЧЕНИЕ.
“Файзер фармацевтика Израиль Лтд.”,
ул. Шенкар 9, Герцлия Питуах
Тел.: [phone], факс: [phone]
www.pfizer.co.il
ПРОЯВЛЕНИЯ КРОВОТЕЧЕНИЯ МОГУТ
ВКЛЮЧАТЬ,
СРЕДИ ПРОЧЕГО:
• Кровотечение в пищеварительной
системе, которое может выражаться в
присутствии крови в кале
(черный/темный
стул), боли (например, боли в животе) и
вздутие
• Кровь в моче (моча красного или
розового
цвета), кровь в моче, выявленная при
анализе мочи
• Кровотечение из глаз, носа или десен
• Кашель с кровью и рвота с

Vara einkenni

Eliquis LPD Israel CC 25 Apr 2022 WC 06 Dec 2023
1
2021-0074009 2022-0081193 2023-0089643
SUMMARY OF PRODUCT CHARACTERISTICS
Patient Card
Please provide patient safety information card (patient card) to each
patient who is prescribed with
Eliquis 2.5 or 5 mg. Explain to the patient the implications of
anticoagulant treatment including the
need for compliance. Please also explain the signs of bleeding and
when to seek medical attention.
The patient card will inform physicians and dentists about the
patient‘s anticoagulation treatment and
will contain emergency contact information. The patient should be
instructed to carry the patient alert
card at all times and present it to every health care provider.
Prescriber guide
This product is marketed with prescriber guide providing important
safety information. Please ensure
you are familiar with this material as it contains important safety
information.
1.
NAME OF THE MEDICINAL PRODUCT
Eliquis 2.5, mg film-coated tablets
Eliquis 5 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg or 5mg apixaban.
Excipients with known effect:
Each 2.5 mg film-coated tablet contains 51.4 mg lactose.
Each 5 mg film-coated tablet contains 102.9 mg lactose (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Eliquis 2.5 mg - yellow, round tablets (diameter of 5.95 mm) debossed
with 893 on one side and 2½
on the other side.
Eliquis 5 mg - pink, oval tablets (9.73 mm x 5.16 mm) debossed with
894 on one side and 5 on the
other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Eliquis 2.5 mg film-coated tablets
Prevention of venous thromboembolic events (VTE) in adult patients who
have undergone elective hip
or knee replacement surgery.
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation
(NVAF), with one or more risk factors, such as prior stroke or
transient ischaemic attack (TIA); age
≥ 75 years; hypertension; diabetes