MIDOLAM 5 MGML

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

MIDAZOLAM

Tilgængelig fra:

RAFA LABORATORIES LTD

ATC-kode:

N05CD08

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

MIDAZOLAM 5 MG/ML

Indgivelsesvej:

I.M, I.V

Recept type:

Required

Fremstillet af:

RAFA LABORATORIES LTD, JERUSALEM

Terapeutisk gruppe:

MIDAZOLAM

Terapeutisk område:

MIDAZOLAM

Terapeutiske indikationer:

midazolam is a short-acting sleep-inducing drug that is indicated:In adults• CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia• ANAESTHESIA- Premedication before induction of anaesthesia- Induction of anaesthesia- As a sedative component in combined anaesthesia• SEDATION IN INTENSIVE CARE UNITSIn children• CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia• ANAESTHESIA- Premedication before induction of anaesthesia• SEDATION IN INTENSIVE CARE UNITS

Autorisation dato:

2022-12-31

Indlægsseddel

)תוחיטב עדימ( הרמחה לע העדוה
)תוחיטב עדימ( הרמחה לע העדוה :ל חולשל(
(
[e-mail]
:ךיראת
28
ב
רבמבונ
2012 :תילגנאב רישכת םש
MIDOLAM 1MG/ML, MIDOLAM 5 MG/ML :םושיר רפסמ
108
42
29066 ,
108
43
29067 :םושירה לעב םש
מ"עב אפר תודבעמ
:עבצב םינמוסמ ןולעב םייונישה
בוהצ
,הפסוה=
קורי
,הקיחמ=
לוחכ
.םוקמ יוניש=
תנווכתמ ןכרצל ןולע
תנווכתמ ןכרצל ןולע
אפורל ןולע
אפורל ןולע
)תוקירזל(
)תוקירזל(
ןולעב קרפ
יחכונ טסקט
שדח טסקט
COMPOSITIO
N
Midazolam 1mg/ml in ampoules of 5
ml.
Midazolam 5mg/ml in ampoules of
1,3,10 ml.
(Preservative-free).
Midazolam 1mg/ml in ampoules of 5 ml.
Midazolam 5mg/ml in ampoules of 1,3,10 ml.
(Preservative-free).
LIST OF EXCIPIENTS
:
Sodium chloride, water for
Injection, sodium hydroxide, HCl
WARNINGS –
)BOX(
Midolam injection has been
associated with severe
cardiorespiratory adverse events
including respiratory depression,
apnea,respiratory arrest, and cardiac
arrest, especially when used for
conscious sedation and in
concomitant use with opioid
agonists or other sedatives, or when
rapidly administered. In some cases,
where this was not recognized
promptly and treated effectively,
death or hypoxic encephalopathy
has resulted.
Midolam should be used only in
hospital or ambulatory care settings,
including physicians’ offices, that
provide for continuous monitoring
of respiratory and cardiac function.
Immediate availability of oxygen,
resuscitative drugs and equipment
and personnel trained in their use
should be assured. Midolam should
be administered intravenously as an
induction agent only by a person
trained in general anesthesia and
should be used for conscious
sedation only when a person skilled
in maintaining a patent airway and
supporting ventilation is present,
because of possible respiratory
depression.
During intravenous administ

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MIDOLAM
®
1MG/ML
MIDOLAM
®
5MG/ML
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: midazolam 1mg/ml or 5 mg/ml for i.v., i.m.
administration.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
•
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death (see section 4.5).
•
Reserve concomitant prescribing of these drugs for use in patients for
whom
alternative treatment options are inadequate.
•
Limit dosages and durations to the minimum required.
•
Follow patients for signs and symptoms of respiratory depression and
sedation.
4.1
THERAPEUTIC INDICATIONS
Midazolam is a short-acting sleep-inducing drug that is indicated:
IN ADULTS
•
CONSCIOUS SEDATION
before and during diagnostic or therapeutic procedures
with or without local anaesthesia
•
ANAESTHESIA
-
Premedication before induction of anaesthesia
-
Induction of anaesthesia
-
As a sedative component in combined anaesthesia
•
SEDATION IN INTENSIVE CARE UNITS
IN CHILDREN
•
CONSCIOUS SEDATION
before and during diagnostic or therapeutic procedures with
or without local anaesthesia
•
ANAESTHESIA
- Premedication before induction of anaesthesia
•
SEDATION IN INTENSIVE CARE UNITS
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Midazolam is a potent sedative agent that requires titration and slow
administration.
Titration is strongly recommended to safely obtain the desired level
of sedation
according to the clinical need, physical status, age and concomitant
medication. In
adults over 60 years, debilitated or chronically ill patients and
paediatric patients,
dose should be determined with caution and risk factors related to
each patient should
be taken into account. Standard dosages are provided in Table 1 and
additional details
are provided in the text following Table 1.
TABLE 1: STANDA