Ubistesin solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

articaine (articaine hydrochloride), epinephrine (epinephrine hydrochloride)

Available from:

3M Deutschland GmbH

ATC code:

N01BB58

INN (International Name):

articaine (articaine hydrochloride), epinephrine (epinephrine hydrochloride)

Dosage:

40mg/ml+ 0,005mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(50) glass cartridges 1,7ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-02-26

Patient Information leaflet

SEITE 1
-
148 X 210 MM
-
3100017063/01
-
ROT (PANTONE 206U)
• SCHWARZ
-
19-021 (KN)
SEITE 3
-
148 X 210 MM
-
3100017063/01
-
ROT (PANTONE 206U)
• SCHWARZ
-
19-021 (KN)
SEITE 4
-
148 X 210 MM
-
3100017063/01
-
SCHWARZ
-
19-021 (KN)
SEITE 5
-
148 X 210 MM
-
3100017063/01
-
SCHWARZ
-
19-021 (KN)
Ubistesin
™
40 mg/ml + 5 micrograms/ml
Solution for injection
ARTICAINE HYDROCHLORIDE/EPINEPHRINE
(ADRENALINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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, dentist or
pharmacist.
-
If you get side effects, talk to your doctor, dentist or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ubistesin is and what it is used for
2. What you need to know before you use Ubistesin
3. How to use Ubistesin
4. Possible side effects
5. How to store Ubistesin
6. Contents of the pack and other information
WHAT UBISTESIN IS AND WHAT IT IS USED FOR
Ubistesin contains the active substances articaine hydrochloride and
epinephrine (adrenaline) hydrochloride. Ubistesin is a local anaes-
thetic (agent which reduces or abolishes sensation, affecting a par-
ticular region). The medicine is used for local anaesthesia (loss of
feeling or sensation in a part of the body) in dentistry in minor
procedures.
Ubistesi is used in adults, adolescents and children aged 4 years
(ca. 20 kg body weight) and older.
WHAT YOU NEED TO KNOW BEFORE YOU USE UBISTESIN
DO NOT USE UBISTESIN
• Ubistesin must not be used in children aged below 4 years
(ca. 20 kg body weight)
• if you are allergic to articaine hydrochloride, epinephrine
(adrena-
line) hydrochloride, sodium sulphite (E221), or to any of the other
ingredients of this medicine (listed in section 6) or to local anaes-
thetics of the amide type.
• if you suffer from disorders of the cardiovascular system, in
particular:
irregular heartbeat (arr

Summary of Product characteristics

SEITE 1
-
148 X 210 MM
-
3100017063/01
-
ROT (PANTONE 206U)
• SCHWARZ
-
19-021 (KN)
SEITE 3
-
148 X 210 MM
-
3100017063/01
-
ROT (PANTONE 206U)
• SCHWARZ
-
19-021 (KN)
SEITE 4
-
148 X 210 MM
-
3100017063/01
-
SCHWARZ
-
19-021 (KN)
SEITE 5
-
148 X 210 MM
-
3100017063/01
-
SCHWARZ
-
19-021 (KN)
Ubistesin
™
40 mg/ml + 5 micrograms/ml
Solution for injection
ARTICAINE HYDROCHLORIDE/EPINEPHRINE
(ADRENALINE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE 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, dentist or
pharmacist.
-
If you get side effects, talk to your doctor, dentist or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ubistesin is and what it is used for
2. What you need to know before you use Ubistesin
3. How to use Ubistesin
4. Possible side effects
5. How to store Ubistesin
6. Contents of the pack and other information
WHAT UBISTESIN IS AND WHAT IT IS USED FOR
Ubistesin contains the active substances articaine hydrochloride and
epinephrine (adrenaline) hydrochloride. Ubistesin is a local anaes-
thetic (agent which reduces or abolishes sensation, affecting a par-
ticular region). The medicine is used for local anaesthesia (loss of
feeling or sensation in a part of the body) in dentistry in minor
procedures.
Ubistesi is used in adults, adolescents and children aged 4 years
(ca. 20 kg body weight) and older.
WHAT YOU NEED TO KNOW BEFORE YOU USE UBISTESIN
DO NOT USE UBISTESIN
• Ubistesin must not be used in children aged below 4 years
(ca. 20 kg body weight)
• if you are allergic to articaine hydrochloride, epinephrine
(adrena-
line) hydrochloride, sodium sulphite (E221), or to any of the other
ingredients of this medicine (listed in section 6) or to local anaes-
thetics of the amide type.
• if you suffer from disorders of the cardiovascular system, in
particular:
irregular heartbeat (arr