ClindaTech Topical Solution

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Clindamycin hydrochloride 10 mg/mL;  

Sẵn có từ:

iNova Pharmaceuticals (New Zealand) Limited

INN (Tên quốc tế):

Clindamycin hydrochloride 10 mg/mL

Liều dùng:

10 mg/mL

Dạng dược phẩm:

Topical solution

Thành phần:

Active: Clindamycin hydrochloride 10 mg/mL   Excipient: Ethanol Dioctyl malate Purified water

Các đơn vị trong gói:

Bottle, HDPE bottle c/w applicator and cap, 6mL, 6 mL

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Union Quimico Farmaceutica SA (Uquifa SA)

Chỉ dẫn điều trị:

For the topical treatment of acne vulgaris particularly forms in which comedones, papules and pustules predominate.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Bottle, HDPE bottle c/w applicator and cap, 6mL - 6 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, HDPE bottle c/w applicator and cap, 30mL - 30 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, HDPE bottle c/w applicator and cap, 50 mL - 50 mL - 24 months from date of manufacture stored at or below 30°C - Bottle, HDPE bottle c/w applicator and cap, 100 mL - 100 mL - 24 months from date of manufacture stored at or below 30°C

Ngày ủy quyền:

2006-06-22

Tờ rơi thông tin

CLINDATECH
®
_ACNE TREATMENT TOPICAL SOLUTION_
_Clindamycin Hydrochloride 1%_
CONSUMER MEDICINE INFORMATION
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START CLINDATECH
TREATMENT, EVEN IF YOU HAVE USED CLINDATECH BEFORE. THIS
LEAFLET ANSWERS SOME COMMON QUESTIONS IN RELATION TO CLINDATECH. IT
DOES NOT CONTAIN ALL THE AVAILABLE INFORMATION. IF
YOU HAVE ANY QUESTIONS OR CONCERNS ABOUT APPLYING THIS MEDICINE,
PLEASE ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS
LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO READ IT AGAIN.
WHAT IS IN THIS LEAFLET
ClindaTech is the brand name of a
skin preparation containing
clindamycin hydrochloride and a
moisturiser. ClindaTech Topical
Solution is a clear solution packed in
a bottle with an outer carton.
It contains clindamycin
hydrochloride 1% (active ingredient),
ethanol, dioctyl malate and purified
water.
It is available in two pack types, i.e.
50mL and 100mL.
WHAT CLINDATECH IS
USED FOR
Clindamycin belongs to a group of
medicines called antibiotics. It is
available only with a doctor's
prescription. Topical clindamycin is
used on the skin to treat certain forms
of acne. It works by decreasing acne
lesions and/or stopping the growth of
skin bacteria which cause acne. It is
usually used by itself, but your
doctor may prescribe one or more
other medicines that are applied on
the skin or taken by mouth. Your
doctor may also prescribe
ClindaTech for another purpose.
Therefore, ask your doctor if you
have any questions why ClindaTech
has been prescribed for your
conditions.
BEFORE YOU USE
CLINDATECH
Ask your doctor or pharmacist about
this medicine
Do not use Clindatech if:
1.
you are allergic to medicines that
contain clindamycin including
those clindamycins taken by
mouth or by injection (e.g.
Dalacin) or lincomycin (e.g.
Lincocin).
2.
you are allergic to any other
ingredients in this formulation.
3.
you have a history of
inflammatory diseases of the
intestines or the large bowel
(colitis, including ulcerative
colitis, colitis caused by
antibiotics, pseudomembranous
colitis, or enteritis

Đặc tính sản phẩm

NEW ZEALAND DATA SHEET
CLINDATECH®
ClindaTech
Page 1 of 7
1 PRODUCT NAME
CLINDATECH 10 mg/mL Topical Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains clindamycin hydrochloride equivalent to
10 mg of clindamycin.
Excipients with known effect:
Ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Topical solution.
A clear, hydroalcoholic solution.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ClindaTech Topical Solution is indicated for the topical treatment of
acne vulgaris particularly forms
in which comedones, papules and pustules predominate.
4.2
Dose and method of administration
Topical.
ClindaTech Solution is for external use only and is applied directly
to the skin.
Wash the entire face with, mild, non-alkaline soap and warm water
prior to any application. Using
the Dab-O-Matic applicator provided, apply a thin film directly to
each acne lesion or to areas having
potential of eruption.
ClindaTech Solution is usually applied to affected areas twice daily,
once every morning and once at
bedtime. The frequency of treatment will depend on the severity of
acne condition as well as skin
tolerance, but should not be more than twice daily.
Advice for monitoring
Treatment of acne vulgaris needs to be individualised according to the
type of lesion predominate
and the response of therapy. Application to the entire face of an
average adult is equivalent to
approximately 2mL of solution or clindamycin 20mg.
Generally, a decrease in the number of inflammatory lesions should be
noticed after two or six
weeks, but more than eight weeks of therapy may be required before any
definite beneficial effects
are observed. Therapy is usually continued until a satisfactory
response is obtained. If condition does
not seem to improve or worsens, modification of treatment or
alternative therapy should be
considered.
NEW ZEALAND DATA SHEET
CLINDATECH®
ClindaTech
Page 2 of 7
4.3
Contraindications
ClindaTech is contraindicated in patients with known history of
hypersensitivity