ATROPINE SULPHATE S.A.L.F. 1 MGML

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

ATROPINE SULFATE

Mevcut itibaren:

RAZ PHARMACEUTICS LTD, ISRAEL

ATC kodu:

A03BA01

Farmasötik formu:

SOLUTION FOR INJECTION

Kompozisyon:

ATROPINE SULFATE 1 MG / 1 ML

Uygulama yolu:

I.M, I.V

Reçete türü:

Required

Tarafından üretildi:

S.A.L.F. S.P.A. LABORATORIO FARMACOLOGICO, ITALY

Terapötik alanı:

ATROPINE

Terapötik endikasyonlar:

Preanesthetic medication to decrease excessive salivation and secretions of the respiratory tract. Treatment of sinus bradycardia, particularly if complicated by hypotension.Antidote in poisoning by organophosphorus.

Yetkilendirme tarihi:

2022-08-31

Bilgilendirme broşürü

.
טסוגוא
2019
,ה/דבכנ ה/אפור
/חקור
,ה/דבכנ ת
:רישכתה לש אפורל ןולעה יכ םכעידוהל
תשקבמ תוחקור זר תרבח
ATROPINE SULPHATE S.A.L.F 1MG/ML
.ןכדוע
.אפורל ןולעב םייתוהמ םייוניש ושענ םהב
םיפיעסה קר םיניוצמ וז העדוהב
תופסותה
םודא עבצב ונמוס
ו
ה
תוקיחמ
עבצב ונמוס
םודא
םע
.הקיחמ וק
:תואירבה דרשמ רתאבש תופורתה רגאמב
ומוסרפ ךרוצל תואירבה דרשמל חלשנ
ןכדועמה ןולעה
www.health.gov.il
:םושירה לעבל היינפ ידי לע ספדומ ולבקל
ןתינו
תוחקור זר
,מ"עב
תכתמה בוחר
6
.ת.א ,
.המידק
,הכרבב
ןומימ לאירא
הנוממ תחקור
ATROPINE SULPHATE S.A.L.F 1MG/ML
:קזוחו ליעפ ביכרמ
Atropine Sulphate 1 mg/ml
:תרשואמ היוותה
Preanesthetic medication to decrease excessive salivation and
secretions of the respiratory tract.
Treatment of sinus bradycardia, particularly if complicated by
hypotension
.
Antidote in poisoning by organophosphorus
.
:אפורל ןולעב ועצובש םינוכדעה
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PRE-ANESTHETIC MEDICATION
_Adults_: The recommended dose is 0.3-0.6 mg by intravenous injection
immediately before the anesthesia induction or by intramuscular
injection
30-60 minutes before the induction.
_Children_: The recommended dose is 0.02 mg/kg (maximum dose 0.6 mg).
TREATMENT OF SINUS BRADYCARDIA
The recommended dose is between 0.3 and 1.0 mg intravenously.
ANTIDOTE in poisoning by organophosphorus
_Adults_: The recommended dose is 2 mg (intramuscularly or
intravenously, taking into account the severity of the poisoning
severity)
every 5-10 minutes, until the skin becomes red and dry, the pupils
dilate and tachycardia appears.
_Children_: The recommended dose is 0.02 mg/kg.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients
listed i

Ürün özellikleri

ATROPINE SULPHATE
S.A.L.F 1 MG/ML
1. NAME OF THE DRUG
Atropine Sulphate S.A.L.F 1mg/ml.
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
1 ml of solution contains:
Active ingredient: Atropine Sulphate
monohydrate 1 mg.
For
the
full
list
of
the
excipients,
see
section
6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
Preanesthetic
medication
to
decrease
excessive salivation and secretions of
the
respiratory tract.
Treatment of sinus
bradycardia, particularly
if complicated by
hypotension.
Antidote in poisoning by organophosphorus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PRE-ANESTHETIC MEDICATION
_Adults_: The recommended dose is 0.3-0.6 mg
by intravenous injection immediately before
the
anesthesia induction or by intramuscular
injection 30-60 minutes before
the induction.
_Children_: The recommended dose is 0.02 mg/kg
(maximum dose 0.6 mg).
TREATMENT OF SINUS BRADYCARDIA
The recommended dose is between 0.3
and 1.0 mg intravenously.
ANTIDOTE in poisoning by organophosphorus
_Adults_: The recommended dose is 2 mg
(intramuscularly
or
intravenously,
taking
into account the poisoning severity)
every
5-10 minutes, until the skin becomes red
and
dry, pupils dilate and tachycardia
appears.
_Children_:
The
recommended
dose
is
0.02 mg/kg.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient or
to
any of the excipients listed in section 6.1.
Angle-closure glaucoma,
esophageal reflux,
pyloric stenosis,
gastrointestinal obstruction,
ulcerative
colitis, prostatic hypertrophy, paralytic
ileus,
intestinal atony, myasthenia gravis (unless
co-administered with anticholinesterase).
However,
all
these
contraindications
are
irrelevant in potentially fatal emergency
situations (such as bradyarrhythmia, poisoning).
4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE
The solution should be clear, colorless and
free of visible particles.
The
ampoule
is
intended
for
a
single,
uninterrupted
administration and any unused
residual
solution should be discarded.
Atropine sulfate should be u