Parabrufen tablets film-coated

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

ibuprofen

Sẵn có từ:

A LAB PHARMACEUTICALS LLC

Mã ATC:

M01AE01

INN (Tên quốc tế):

ibuprofen

Liều dùng:

600mg

Dạng dược phẩm:

tablets film-coated

Các đơn vị trong gói:

(10/1x10/) in blister

Loại thuốc theo toa:

Prescription

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2022-03-09

Đặc tính sản phẩm

A - L A B P H A R M A C E U P T I C A L S , L L C
Address: Kochinyan 13/16 street Yerevan - Armenia
Tell: ( [phone] Web: www.alab.am E-Mail: [e-mail]
C O N F I D E N T I A L P a g e 1 o f 1 4
1.3 PRODUCT INFORMATION
1.3.1 SPC, LABELING & PACKAGE LEAFLET
SPC – SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PARABRUFEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 600mg.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet for oral use
Pink colored caplet shaped film-coated tablet having break line on one
side and plain on
the other side.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Parabrufen tablet is indicated for its analgesic and anti-inflammatory
effects in the
treatment of rheumatoid arthritis (including juvenile rheumatoid
arthritis or Still's disease),
ankylosing
spondylitis,
osteoarthritis
and
other
non-rheumatoid
(seronegative)
arthropathies.
In the treatment of non-articular rheumatic conditions, Parabrufen
tablet is indicated in
periarticular
conditions
such
as
frozen
shoulder
(capsulitis),
bursitis,
tendinitis,
tenosynovitis and low back pain; Parabrufen tablet can also be used in
soft tissue injuries
such as sprains and strains.
Parabrufen tablet is also indicated for its analgesic effect in the
relief of mild to moderate
pain such as dysmenorrhoea, dental and post-operative pain and for
symptomatic relief of
headache, including migraine headache.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should start with the lowest dose anticipated to be
effective, which can
subsequently be adjusted, depending on the therapeutic response and
any undesirable
effects. In long-term treatment a low maintenance dose should be the
aim.
A - L A B P H A R M A C E U P T I C A L S , L L C
Address: Kochinyan 13/16 street Yerevan - Armenia
Tell: ( [phone] Web: www.alab.am E-Mail: [e-mail]
C O N F I D E N T I A L P a g e 2 o f 1 4
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration