Voltaren suppositories

Country: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

diclofenac (diclofenac sodium)

Доступно од:

Delpharm Huningue S.A.S.

АТЦ код:

M01AB05

INN (Међународно име):

diclofenac (diclofenac sodium)

Дозирање:

100mg

Фармацеутски облик:

suppositories

Јединице у пакету:

(5) in blister

Тип рецептора:

Prescription

Статус ауторизације:

Registered

Датум одобрења:

2017-04-03

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Voltaren
®
Suppositories 25 mg
Voltaren
®
Suppositories 50 mg
Voltaren
®
Suppositories 100 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (diclofenac
sodium).
Each suppository contains 25 mg, 50 mg or 100 mg diclofenac sodium
Ph.Eur.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORMS
Suppositories.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Adults and Elderly_
:
Relief of all grades of pain and inflammation in a wide range of
conditions, including:
(i)
arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing
spondylitis, acute gout;
(ii)
acute musculo-skeletal disorders such as periarthritis (for example
frozen shoulder), tendinitis,
tenosynovitis, bursitis;
(iii)
other painful conditions resulting from trauma, including fracture,
low back pain, sprains,
strains, dislocations, orthopaedic, dental and other minor surgery.
_Children (aged 1-14 years) _
(i)
Juvenile chronic arthritis (only for suppositories 25 mg)
_Children (aged 6 years and above) _
(ii)
As monotherapy or as adjunct therapy with morphine or other opiates
(due to its opiate- sparing
effect) for the relief of acute post-operative pain.
In keeping with standard therapeutic principles, the underlying
disease should be treated with specific
therapy as appropriate. Fever alone is not an indication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The suppositories should be inserted well into the rectum.It is
recommended to insert the
suppositories after passing stools. Not to be taken by mouth, as per
rectal administration only.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
2
necessary to control symptoms (see section 4.4 Special warnings and
precautions for use).
ADULTS:
100-150 mg daily, in divided doses. Usually 75-100 mg/day with
moderate symptoms and long-term
therapy.
The recommended maximum daily dose o