ClindaTech Clindamycin hydrochloride 10mg/mL solution bottle

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

clindamycin hydrochloride, Quantity: 10 mg/mL

Dostępny od:

iNova Pharmaceuticals (Australia) Pty Ltd

Forma farmaceutyczna:

Solution

Skład:

Excipient Ingredients: dioctyl malate; purified water; ethanol

Droga podania:

Topical

Sztuk w opakowaniu:

50mL, 100mL, 10mL, 30mL, 6mL

Klasa:

Medicine Registered

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

ClindTech Solution is indicated for the topical treatment of acne vulgaris, particularly forms in which comedones, papules and pastules predominate.

Podsumowanie produktu:

Visual Identification: Clear, colourless solution.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status autoryzacji:

Licence status A

Data autoryzacji:

1998-11-23

Ulotka dla pacjenta

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

Charakterystyka produktu

1
AUSTRALIAN PRODUCT INFORMATION – CLINDATECH
® (CLINDAMYCIN
HYDROCHLORIDE) SOLUTION
1
NAME OF THE MEDICINE
Clindamycin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ClindaTech is a clear hydroalcoholic solution containing clindamycin
hydrochloride 1%. Dioctyl
malate, a noncomedogenic humectant, is incorporated to prevent skin
dryness.
ClindaTech contains alcohol 69 % v/v. For the full list of excipients,
see _Section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
ClindaTech Clindamycin hydrochloride 10 mg/mL solution bottle. A
clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ClindaTech is indicated for the topical treatment of acne vulgaris,
particularly forms in which
comedones, papules and pustules predominate.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ClindaTech is for external use only and is applied directly on 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 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.
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 2 mL of solution or clindamycin 20 mg.
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.
4.3
C
ONTRAINDICATIONS
ClindaTech is contraindicated