Vurdon gel for external use

Држава: Арменија

Језик: Енглески

Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активни састојак:

diclofenac (diclofenac diethylammonium)

Доступно од:

Help S.A.

АТЦ код:

M02AA15

INN (Међународно име):

diclofenac (diclofenac diethylammonium)

Дозирање:

10mg/g

Фармацеутски облик:

gel for external use

Јединице у пакету:

25g aluminium tube

Тип рецептора:

OTC

Статус ауторизације:

Registered

Датум одобрења:

2017-04-25

Карактеристике производа

SUMMARY PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Vurdon 1% Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
1g
of
Vurdon
Gel
contains
11.6
mg
of
the
active
substance
diclofenac
diethylammonium, which corresponds to 10 mg diclofenac sodium.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Gel
White gel with characteristic odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints, e.g. due to
sprains, strains and
bruises
- localised forms of soft tissue rheumatism
It is recommended that the treatment be reviewed after 14 days in
these indications. For
the treatment of osteoarthritis of superficial joints such as the
knee. In the treatment of
osteoarthritis, therapy should be reviewed after 4 weeks.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_: Vurdon gel should be rubbed gently into the skin. Depending
on the size of the
affected site to be treated 2-4g (a circular shaped mass approximately
2.0-2.5cm in
diameter) should be applied 3 - 4 times a daily.
After application, the hands should be washed unless they are the site
being treated.
_Use in the elderly_: The usual adult dosage may be used.
_Children and adolescents: _There are insufficient data on efficacy
and safety available for
the children and adolescents below 12 years of age (see also
contraindications section
4.3). In children aged 12 years and over, if this product is required
for more than 7 days
for pain relief or if the symptoms worsen the patient/parents of the
adolescent is/are
advised to consult a doctor.
If large areas of the body are covered with gel, systemic absorption
will be greater and
the risk of side-effects increased, especially if the therapy is used
frequently.
4.3 CONTRAINDICATIONS
• Patients with or without chronic asthma in whom attacks of asthma,
urticaria or acute
rhinitis are precipitated by acetylsalicylic acid (aspirin) or other
non- steroidal anti-
inflammatory drug