Calgel

País: Armènia

Idioma: anglès

Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

ingredients actius:

lidocaine (lidocaine hydrochloride), cetylpyridinum (cetylpyridinum chloride)

Disponible des:

GlaxoSmithKline Pharmaceuticals S.A.

Designació comuna internacional (DCI):

lidocaine (lidocaine hydrochloride), cetylpyridinum (cetylpyridinum chloride)

Dosis:

3,3mg/g+1mg/g

formulario farmacéutico:

gel

tipo de receta:

Prescription

Informació per a l'usuari

Calgel
Lidocaine hydrochloride/ cetylpyridinium chloride
Composition
Active substance
Calgel dental gel contains 0.33% w/w of lidocaine hydrochloride and
0.10% w/w of cetylpyridinium chloride.
Excipients
Sorbitol, Macrogol 300, Ethanol, Saccharin Sodium, Glycerol, Caramel,
Levomenthol, Hydroxyethylcellulose 5000,
Xylitol, Laureth 9, PEG-40 hydrogenated castor oil concentrate
(Cremophor, RH410), Sodium citrate, Citric acid
monohydrate, Herbal flavor.
Pharmaceutical form
The product is a yellowish brown colored gel with a characteristic
odor. Smooth and free from grittiness, lumps and
foreign matter.
ATC code: N01 BB52
Indications
Calgel dental gel is indicated for use in teething. Calgel dental gel
acts quickly to help relieve teething pain and
soothe toddlers’ and infants’ gums. It also has mild antiseptic
properties.
Dosage and administration
Route of Administration
For oromucosal use.
Adults
There are no relevant data available.
Children
Calgel dental gel is suitable for babies from the age of 3 months.
A small quantity of dental gel, approximately 7.5 mm (0.22 g), should
be squeezed onto the tip of a clean finger and
rubbed gently onto the affected area of the gum.
Application may be repeated after an interval of 20 minutes, if
necessary, with up to six applications in one day.
Elderly
There are no relevant data available.
Renal impairment
There are no relevant data available.
Hepatic impairment
There are no relevant data available.
Contraindications
Calgel dental gel is contraindicated in patients with hypersensitivity
to lidocaine hydrochloride and/ or cetylpyridinium
chloride or to any of the excipients.
Warnings and Precautions
Use in children
The recommended dose should not be exceeded.
Keep out of the sight and reach of children.
Contains sorbitol solution 70%. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
This medicinal product contains small amount of ethanol (alcohol),
less than 100mg per .
Contains

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CALGEL
_Lidocaine hydrochloride/ cetylpyridinium chloride _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance _
Calgel dental gel contains 0.33% w/w of lidocaine hydrochloride and
0.10% w/w of_ _ cetylpyridinium
chloride.
_ _
3.
PHARMACEUTICAL FORM
The product is a yellowish brown colored gel with a characteristic
odor. Smooth and free from grittiness,
lumps and foreign matter.
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Calgel dental gel is indicated for use in teething. Calgel dental gel
acts quickly to help relieve teething pain
and soothe toddlers’ and infants’ gums. It also has mild
antiseptic properties.
4.2
Posology and Method of Administration
_Route of Administration _
For oromucosal use.
_Adults _
There are no relevant data available.
_Children _
Calgel
dental gel is suitable for babies from the age of 3_ _months.
A small quantity of dental gel, approximately 7.5 mm_ _(0.22 g),
should be squeezed onto the tip of a clean
finger and rubbed gently onto the affected area of the gum.
Application may be repeated after an interval of 20_ _minutes, if
necessary, with up to six applications in one
day.
_Elderly _
There are no relevant data available.
_Renal impairment _
There are no relevant data available.
_Hepatic impairment _
There are no relevant data available.
4.3 CONTRAINDICATIONS
Calgel
dental gel is contraindicated in patients with hypersensitivity to
lidocaine hydrochloride and/ or
cetylpyridinium chloride or to any of the excipients.
4.4 WARNINGS AND PRECAUTIONS
_Use in children _
The recommended dose should not be exceeded.
Keep out of the sight and reach of children.
Contains sorbitol solution 70%. If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
This medicinal product contains small amount of ethanol (alcohol),
less than 100mg per .
Contains Castor oil polyoxyl hydrogenated, may cause stomach upset and
diarrhea.