DALACIN T TOPICAL SOLUTION 1%

Nazione: Malesia

Lingua: inglese

Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Principio attivo:

CLINDAMYCIN PHOSPHATE

Commercializzato da:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nome Internazionale):

CLINDAMYCIN PHOSPHATE

Confezione:

30ml mL; 30 ml mL

Prodotto da:

Zoetis LLC

Foglio illustrativo

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DALACIN
®
T TOPICAL SOLUTION
Clindamycin phosphate (1% w/v)
2
WHAT IS IN THIS LEAFLET
1.
What Dalacin T is used for
2.
How Dalacin T works
3.
Before you use Dalacin T
4.
How to use Dalacin T
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Dalacin
T
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DALACIN T IS USED FOR
Dalacin T is used on the skin to treat
acne.
HOW DALACIN T WORKS
Dalacin T works by killing or
stopping the growth of the bacteria
causing the acne.
BEFORE YOU USE DALACIN T
-
_When you must not use it_
-
If you are allergic
(hypersensitive) to clindamycin,
lincomycin or to any of the other
ingredients in this medicine.
-
If you have, or have suffered
from, a history of inflammatory
bowel disease or bowel
inflammation following
treatment with antibiotics
_Pregnancy and lactation_
If you are pregnant or think you
might be pregnant you should contact
your doctor before using Dalacin T.
Clindamycin should be used during
the first trimester of pregnancy only if
clearly needed.
Tell your doctor if you will be
breast-feeding while using Dalacin T
as the active substance in this
medicine may be passed into breast
milk. Your doctor will advise you
whether to discontinue nursing or to
discontinue Dalacin T.
Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start to use it_
Check with your doctor before you
use this medicine if
-
you frequently develop allergies.
-
you have diarrhoea or usually get
diarrhoea when you take
antibiotics.
-
_Taking other medicines_
Tell your doctor if you are taking
any other medicines, including any
that you buy without a prescription
from a pharmacy, supermarket or
health food shop.
In particular, tell your doctor if you
have been given neuromuscular
blocking agents (used as
anesthesia).
HOW TO USE DALACIN T
-
_How much to use_
Follow all directions given to you
by your doctor and pharmacist
carefully. They

Scheda tecnica

Pfizer Confidential
LPD Title : Clindamycin phosphate LPD Date : 2317 Ma yrch 20178 Country : Malaysia Reference : CDS v 79.0 dated 023 February July 20148 Reason : Update to section 5.1 for Clindamycin Topical. Change manufacturer LEN to Zoetis LLC Dalacin T
Clindamycin phosphate
1. NAME OF THE MEDICINAL PRODUCT
Dalacin T
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of clindamycin phosphate topical solution contains clindamycin phosphate equivalent to
10 mg clindamycin base.
3. PHARMACEUTICAL FORM
Topical solution
4. CLINICAL PARTICULARS
4.1. Therapeutic indications Dalacin T Topical Solution clindamycin is indicated in the treatment of acne vulgaris, especially during the inflammated papulopustulary phase. 4.2. Posology and method of administration Apply a thin film of topical clindamycin twice daily to tothe the affected area.
Clindamycin topical lotion should be shaken immediately before using.
Keep all liquid dosage forms in containers tightly closed.
Use in children
Safety and effectiveness in pediatric patients under the age of 12 have not been established.
Use in elderly
Clinical studies for Dalacin T topical clindamycin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between the elderly and younger patients.
Comment [z1]: As per approved by NPCB
Comment [z2]: As per approved by NPCB
Comment [SM3]: Referenced to CDS v9 Feb 2018