Canesten 10% vaginal cream

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
07-06-2018
Tabia za bidhaa Tabia za bidhaa (SPC)
07-06-2018

Viambatanisho vya kazi:

Clotrimazole

Inapatikana kutoka:

Bayer Plc

ATC kanuni:

G01AF02

INN (Jina la Kimataifa):

Clotrimazole

Kipimo:

100mg/1gram

Dawa fomu:

Vaginal cream

Njia ya uendeshaji:

Vaginal

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 07020200; GTIN: 5010605054631

Taarifa za kipeperushi

                                BAYER REF NO:
TRIDENT REFERENCE NO:
BRAND:
RANGE:
PRODUCT:
PACK TYPE:
PACK SIZE:
ACTION:
DATE:
COUNTRY:
FINISHED GOODS CODE:
SYNAPS REQUEST CODE:
COMPONENT CODE:
CAD REF NO:
PRINTER:
PACKAGING SITE:
SUBSTRATE:
BARCODE 1 TYPE:
BARCODE 1 MAG:
BARCODE 2 TYPE:
BARCODE 2 MAG:
PHARMACODE NO/NE:
PIL 174 x 297 folded 174 x 38 (P039)
Canesten
Cream
10percent vaginal cream
Leaflet
Malta/UK
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100
PLEASE NOTE THAT ANY LOW RESOLUTION PAPER CANON COLOUR
COPIES ASSOCIATED WITH THIS JOB SHOULD BE REFERRED TO FOR
CONTENT, LAYOUT AND COLOUR SEPARATION ONLY.
UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
STUDIO USE ONLY
V1.0
SM•ART CHECK RESULTS:
CUTTER
GUIDES
TECHNICAL & NON PRINTING ITEMS
BAYER ARTWORK PANEL
5 g
PACKAGING SITE APPROVAL:
ARTWORK
APPROVAL PANEL
NAME:
DATE:
ACTION:
COUNTRY APPROVAL:
NAME:
DATE:
ACTION:
BAY295004
MAIN TEXT (BODY COPY):
HEIGHT (BASED ON LOWER CASE X):
9 pt
1.3 mm
FONT SIZE PANEL
08/11/17
TL019578
8092739-15
04384044
B
TR1314316
EVITA LAUKA
G=1; O=0; R=1; - EL - 08/11/17 12:04:59
N/A
N/A
10001(48)
N/A
N/A
Kern Pharma [ES]
Generic Bayer
White Paper
1
LTH
PANTONE 485 C
2
LTH
PANTONE COOL GRAY 11 C
3
LTH
PROCESS BLACK
COLOURS
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or
pharmacist.
•
This medicine has been prescribed for you. Do not give it
to anyone else under any circumstances.
•
If you have any unusual effects after using this product,
tell your doctor.
IN THIS LEAFLET
1.
What is Canesten Vaginal Cream and what is it used for?
2.
Before you use Canesten Vaginal Cream
3.
How to use Canesten Vaginal Cream
4.
Possible side effects
5.
How to store Canesten Vaginal Cream
6.
Further information
1. WHAT IS CANESTEN® VAGINAL
CREAM AND WHAT IS IT USED
FOR?
Canesten Vaginal Cream is a single application, full cou
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                OBJECT 1
CANESTEN 10% W/W VAGINAL CREAM
Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc
1. Name of the medicinal product
Canesten 10% w/w Vaginal Cream
2. Qualitative and quantitative composition
Clotrimazole 10% w/w
For excipients, see 6.1
3. Pharmaceutical form
Vaginal cream.
4. Clinical particulars
4.1 Therapeutic indications
Canesten vaginal cream is recommended for the treatment of candidal
vaginitis.
4.2 Posology and method of administration
The cream should be administered intravaginally using the applicator
supplied.
_ADULTS:_
The contents of the filled applicator (5g) should be inserted as
deeply as possible into the vagina,
preferably at night. A second treatment may be carried out if
necessary.
Generally:
treatment during the menstrual period should not be performed due to
the risk of the cream being washed
out by the menstrual flow. The treatment should be finished before the
onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal
products while using this product.
Vaginal intercourse should be avoided in case of vaginal infection and
while using this product because
the partner could become infected.
_CHILDREN:_
Not for use in children under 16.
4.3 Contraindications
Hypersensitivity to clotrimazole or any other excipients listed in
section 6.1.
4.4 Special warnings and precautions for use
Patients should be advised to consult their physician if the symptoms
have not been relieved within one
week of using Canesten Vaginal Cream. Canesten Vaginal Cream can be
used again if the candidal
infection returns after 7 days. However, if the candidal infection
recurs more than twice within six
months, patients should be advised to consult their physician.
This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of
interaction
Laboratory tests have suggested that, when used together, this product
may cause damage to latex
contraceptives. Consequ
                                
                                Soma hati kamili
                                
                            

Tafuta arifu zinazohusiana na bidhaa hii