Rufixalo tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rivaroxaban

Available from:

Alkaloid AD Skopje

ATC code:

B01AF01

INN (International Name):

rivaroxaban

Dosage:

20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-06-22

Summary of Product characteristics

Rufixalo 15 mg; 20 mg mg film-coated tablets
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rufixalo 15 mg film-coated tablets
Rufixalo 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Rufixalo 15 mg film-coated tablets: _
Each film-coated tablet contains 15 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 21.75 mg lactose, see section 4.4.
_Rufixalo 20 mg film-coated tablets: _
Each film-coated tablet contains 20 mg rivaroxaban.
Excipient with known effect
Each film-coated tablet contains 29.00 mg lactose, see section 4.4
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
_Rufixalo 15 mg film-coated tablets:_
Red, round biconvex tablets, debossed with “15” on one side and
plain on the other side.
_Rufixalo 20 mg film-coated tablets:_
Brown-red, round biconvex tablets, debossed with “20” on one side
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults _
Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation with
one or more risk factors, such as congestive heart failure,
hypertension, age ≥ 75 years, diabetes mellitus,
prior stroke or transient ischaemic attack.
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE),
and prevention of recurrent
DVT and PE in adults. (See section 4.4 for haemodynamically unstable
PE patients.)
_ _
_Paediatric population _
_ _
Rufixalo 15 mg; 20 mg mg film-coated tablets
Summary of Product Characteristics
_Rufixalo 15 mg film-coated tablets: _
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than 18 years and weighing from 30 kg to 50 kg
after at least 5 days of initial
parenteral anticoagulation treatment.
_ _
_Rufixalo 20 mg film-coated tablets:_
Treatment of venous thromboembolism (VTE) and prevention of VTE
recurrence in children and
adolescents aged less than