Xylestesin-A solution for injection

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

lidocaine (lidocaine hydrochloride), epinephrine (epinephrine hydrochloride)

제공처:

3M Deutschland GmbH

ATC 코드:

N01BB52

INN (국제 이름):

lidocaine (lidocaine hydrochloride), epinephrine (epinephrine hydrochloride)

복용량:

20mg/ml+ 0,015mg/ml

약제 형태:

solution for injection

패키지 단위:

(50) cartridges 1,7ml

처방전 유형:

Prescription

승인 상태:

Registered

승인 날짜:

2019-02-08

환자 정보 전단

1
3M ESPE
Xylestesin-A
SOLUTION for injection
(local anesthetic for dentistry)
INFORMATION FOR USE
3M Deutschland GmbH
Carl-Schurz-Straße 1
41453 Neuss
Germany
COMPOSITION
1 ml solution for injection contains:
_Active ingredients: _
Anhydrous lidocaine hydrochloride
20
mg
(R)-epinephrine hydrochloride
0.015 mg
(equivalent to 0.0125 mg base)
_Other ingredients: _
Anhydrous sodium sulphite max.
0.6
mg
(equivalent to max. 0.31 mg SO2)
Sodium chloride
Water for injections
PHARMACEUTICAL FORM AND CONTENT
Solution for injection, 50 cartridges of 1.7 ml each
LOCAL ANESTHETIC OF THE ANILIDE SERIES WITH VASOCONSTRICTIVE
COMPONENT FOR ADMINISTRATION IN DENTISTRY
THERAPEUTIC INDICATIONS
Infiltration anesthesia and nerve-block in dentistry.
CONTRAINDICATIONS
_Due to the local anesthetic ingredient lidocaine, XYLESTESIN-A cannot
be _
_used in the event of _
-
known allergy or hypersensitivity to local anesthetics of the amide
type
-
severe impairment of the nervous impulses and conduction system of the
heart (e.g. grade II and III AV block, pronounced bradycardia)
-
acutely decompensated cardiac insufficiency (acute failure of cardiac
output)
2
- severe hypotension (very low blood pressure)
_Due to the content of epinephrine as a vasoconstrictor admixture, _
_XYLESTESIN-A also cannot be used in the event of _
-
paroxysmal tachycardia or high-frequency continuous arrhythmia
-
pronounced coronary insufficiency
-
severe hypertension (high blood pressure)
-
thyrotoxicosis (hyperactivity of the thyroid)
-
narrow-angle glaucoma
-
decompensated diabetic metabolic condition
-
pheochromocytoma
-
concurrent treatment, or treatment during the past 14 days, with
tricyclic
antidepressants or monoamine oxidase (MAO) inhibitors
_XYLESTESIN-A must be used with particular caution in the event of _
-
severe impairment to the renal or hepatic function
-
angina pectoris (tightness in the chest)
-
arteriosclerosis (vascular sclerosis)
-
injection into an inflamed (infected) area
-
considerable impaired blood coagulation
WARNING
XYLESTESIN-A must

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
XYLESTESIN
TM
-A
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml solution for injection contains:
Anhydrous lidocaine hydrochloride
20
mg
(R)-Epinephrine hydrochloride
0.015 mg
(equivalent to 0.0125mg base)
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infiltration anesthesia and nerve-block in dentistry.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The following dosage guidelines apply:
The smallest possible volume of solution which will lead to effective
anesthesia should
be used.
The dosage should be individually determined from case to case
depending on the method
used and special characteristics of the particular case.
As a rule, doses of 1 - 4 ml are sufficient for young persons over 15
years of age and
adults.
In children weighing about 20 - 30 kg, doses of 0.25 - 1 ml are
sufficient; and in children
weighing 30 - 45 kg, 0.5 - 2 ml.
Increased plasma levels of XYLESTESIN-A_ _can occur in older patients
due to
diminished metabolic processes and lower distribution volume. The risk
of accumulation
of XYLESTESIN-A increases in particular due to repeated application
(e.g. post-
injection). A similar effect can ensue from the reduced general
condition of the patient, as
2
well as severely impaired hepatic and renal function. A lower dosage
range is thus
recommended in all such cases (minimum quantity for sufficient
anesthetic depth).
The _XYLESTESIN-A_ dose is to be likewise reduced in patients with
certain pre-existing
diseases (angina pectoris, arteriosclerosis) or a local anesthetic
which does not contain a
vasoconstrictor should be used.
The maximum dose of the active ingredient lidocaine with
vasoconstrictor admixture is
500 mg (7 mg/kg body weight). However, due to the addition of
epinephrine 1:80,000,
the maximum administered quantity of 20 ml solution for injection
(equivalent to 0.25 mg
epinephrine) must not be exceeded.
No more than 5 mg lidocaine per kg body weight should be injected in
ch