CELAXIB celecoxib 200 mg capsule blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

celecoxib, Quantity: 200 mg

Доступна с:

Alphapharm Pty Ltd

Фармацевтическая форма:

Capsule, hard

состав:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; povidone; lactose monohydrate; sodium lauryl sulfate; colloidal anhydrous silica; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol; Shellac; sulfuric acid

Администрация маршрут:

Oral

Штук в упаковке:

120, 30, 5, 20, 10, 50, 60

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

For the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.,For the treatment of primary dysmenorrhoea in adults.,For the short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.

Обзор продуктов:

Visual Identification: No. 2 light brown/white body, opaque, hard-shell gelatin capsule with white to off-white powder. Axially printed with Mylan over CE 200 in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2018-02-23

тонкая брошюра

CELAXIB
_contains the active ingredient celecoxib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CELAXIB.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking CELAXIB
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CELAXIB IS
USED FOR
CELAXIB is used to relieve the
symptoms of joint pain, tenderness,
swelling and stiffness in:
•
osteoarthritis,
•
rheumatoid arthritis and
•
ankylosing spondylitis (a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine).
CELAXIB also provides short-term
pain relief in conditions such as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
CELAXIB belongs to a group of
medicines called Coxibs which are
used to relieve pain and
inflammation in a number of
conditions.
Although CELAXIB can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELAXIB
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
CELAXIB is available only with a
doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
CELAXIB is not recommended for
use in children or adolescents under
18 years of age.
BEFORE YOU TAKE
CELAXIB
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CELAXIB IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
celecoxib
•
any of the ingredients listed at the
end of this leaflet
•
sulfonamides, a group of
medicines which include, for
example, certain antibiotics (if
you are not sure if you are taking
one of these medicines ask your
pharmacist).
Some of the symptoms of an allergic
reaction may in

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION
CELAXIB
_celecoxib capsules _
1
NAME OF THE MEDICINE
Celecoxib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Celaxib 100 mg capsule contains 100 mg of celecoxib.
Each Celaxib 200 mg capsule contains 200 mg of celecoxib.
Excipients with known effect:
Contains lactose and traces of galactose and sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
CELAXIB (celecoxib) 100 mg capsules: A No. 4, blue opaque cap and
white opaque body, hard-shell gelatin
capsule filled with white to off-white powder. The capsule is axially
printed with MYLAN over CE 100 in black
ink on the cap and body.
CELAXIB (celecoxib) 200 mg capsules: A No. 2, light brown opaque cap
and white opaque body, hard-shell
gelatin capsule filled with white to off-white powder. The capsule is
axially printed with MYLAN over CE 200
in black ink on the cap and body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of osteoarthritis, rheumatoid arthritis
and ankylosing spondylitis.
For the treatment of primary dysmenorrhoea in adults.
For the short-term treatment of acute pain in adults following surgery
or musculoskeletal and/or soft tissue injury.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
As the cardiovascular risks of celecoxib may increase with dose and
duration of exposure, the shortest duration
possible and the lowest effective daily dose should be used (see
section 5.1 Pharmacodynamic Properties -
Clinical Trials).
Patients on long-term treatment should be reviewed regularly, such as
every three months, with regards to
efficacy, risk factors and ongoing need for treatment.
ADULTS
_OSTEOARTHRITIS _
The usual recommended daily dose is 200 mg taken once daily or in two
divided doses.
CELAXIB – PRODUCT INFORMATION
2
_RHEUMATOID ARTHRITIS _
The recommended daily dose is 200 mg taken in two divided doses.
A dose of up to 400 mg daily may be used for short-term management of
disease flares or exacerbations.
_ANKYLOSING SPONDYLITIS _
The maximu