SOOLANTRA ivermectin 10 mg/g cream tube

Country: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

ivermectin, Quantity: 10 mg/g

থেকে পাওয়া:

Galderma Australia Pty Ltd

INN (International Name):

Ivermectin

ফার্মাসিউটিকাল ফর্ম:

Cream

রচনা:

Excipient Ingredients: glycerol; isopropyl palmitate; carbomer copolymer (type B); dimeticone 20; disodium edetate; citric acid monohydrate; cetyl alcohol; stearyl alcohol; ceteareth-20; sorbitan stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; phenoxyethanol; propylene glycol; oleyl alcohol; sodium hydroxide; purified water

প্রশাসন রুট:

Topical

প্যাকেজ ইউনিট:

30 g, 45 g, 15 g, 2 g, 60 g

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

SOOLANTRA is indicated for the topical treatment of inflammatory lesions of rosacea (papulo-pustular) in adult patients 18 years and over.

পণ্য সারাংশ:

Visual Identification: White to pale yellow cream; Container Type: Tube; Container Material: PP/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

2015-09-14

তথ্য লিফলেট

SOOLANTRA
1
SOOLANTRA
® CREAM
_ _
_Ivermectin 10mg/g (1% w/w) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SOOLANTRA.
It does not contain all the available
information. It does not use the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using SOOLANTRA against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT SOOLANTRA IS
USED FOR
SOOLANTRA contains the active
substance ivermectin that belongs to a
group of medicines called avermectins.
SOOLANTRA is used to treat pimples
and spots found with rosacea.
Your doctor, however may prescribe it
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
SOOLANTRA HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a
doctor’s prescription.
SOOLANTRA is not addictive.
BEFORE YOU USE
SOOLANTRA
_WHEN YOU MUST NOT USE IT _
DO NOT USE SOOLANTRA:

if you have an allergy to any
medicine containing ivermectin

if you have an allergy to any of the
ingredients listed at the end of this
leaflet

for any children under 18 years of
age
Some of the symptoms of an allergic
reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or
other parts of the body

rash, itching or hives of the skin
DO NOT USE SOOLANTRA AFTER THE
USE BY (EXPIRY) DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
_BEFORE YOU START TO USE IT_
TELL YOUR DOCTOR IF YOU HAVE ALLERGIES
TO ANY OTHER MEDICINES, FOODS,
PRESERVATIVES OR DYES.
SOOLANTRA contains cetyl alcohol
and stearyl alcohol which may cause
local skin reactions (e.g. contact
dermatitis), methyl hydroxybenzoate
(E218) and propyl hydroxybenzoate
(E217) which may

পণ্য বৈশিষ্ট্য

1
AUSTRALIAN PRODUCT INFORMATION
SOOLANTRA
® (IVERMECTIN) CREAM
1.
NAME OF THE MEDICINE
Ivermectin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of SOOLANTRA cream contains 10 mg (or 1.0% w/w) of
ivermectin.
EXCIPIENTS WITH KNOWN EFFECT
Methyl hydroxybenzoate
Propyl hydroxybenzoate
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
SOOLANTRA is a white to pale yellow hydrophilic cream.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SOOLANTRA is indicated for the topical treatment of inflammatory
lesions of rosacea
(papulo-pustular) in adult patients 18 years and over.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
One application a day for up to 4 months. SOOLANTRA should be applied
daily over the
treatment course. The treatment course may be repeated.
In case of no improvement after 3 months, the treatment should be
discontinued. For optimal
facial treatment, it is recommended that five small pea-size amounts,
the total estimated to be no
more than 1 g, are applied to the main areas of the face (i.e.
forehead, chin, nose, each cheek)
daily. The cream should be spread as a thin layer across the entire
face, avoiding the eyes and
lips.
After SOOLANTRA has dried, a high sunscreen protection factor (SPF)
sunscreen should be
applied to treated areas that are likely to be exposed to the sun, or
other sun-exposure reduction
methods should be used (e.g. hats, clothing). Cosmetics and sunscreens
may also be applied
after SOOLANTRA has dried.
SOOLANTRA should be applied only to the face.
Hands should be washed after applying SOOLANTRA.
2
SOOLANTRA is not for oral, ophthalmic, or intravaginal use.
Special populations
_Elderly patients _
No dosage adjustment is necessary in the geriatric population (see
section
4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE
,
USE IN THE ELDERLY
).
_Paediatric population _
The safety and efficacy of SOOLANTRA in children and adolescents aged
less than 18 years
have not been established. No data are available.
4.3 CONTRAINDICATIONS
Hypersensiti