Midazolam Injection Solution for injection 5mg/ml

Ország: Tanzánia

Nyelv: angol

Forrás: Tanzania Medicinces & Medical Devices Authority

Aktív összetevők:

Midazolam Injection BP 5 mg/ml

Beszerezhető a:

Intas Pharmaceuticals Limited, INDIA

ATC-kód:

Hypnotics and sedatives drugs

INN (nemzetközi neve):

Midazolam Injection BP 5 mg/ml

Adagolás:

5mg/ml

Gyógyszerészeti forma:

Solution for injection

Gyártó:

Intas Pharmaceuticals Limited, INDIA

Termék összefoglaló:

Physical description: A clear colorless to pale yellow solution filled in a clear glass ampoule. When examined under suitable conditions of visibility it should conditions of visibility it should be practically free from foreign particles; Local technical representative: PHARMAJEN LIMITED (61840)

Engedélyezési státusz:

Registered/Compliant

Engedély dátuma:

2022-12-05

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Midazolam Injection BP 5 mg/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains: Midazolam (as hydrochloride) 5 mg
See section 6.1 for List of excipients
3.
PHARMACEUTICAL FORM
Dosage form: Solution for Injection/infusion
Midazolam Injection is a clear colorless to pale yellow solution
filled in a clear glass
ampoule.
When
examined
under
suitable
conditions
of
visibility
it
should
be
practically free from foreign particles.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam is a short acting sleep-inducing active substance 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 the
table below.
Additional details are provided in the text following the table.
INDICATION
ADULTS < 60 Y
ADULTS ≥ 60Y /
DEBILITATED OR
CHRONICALLY ILL
CHILDREN
Conscious
sedation
i.v.
Initial dose: 2 – 2.5
mg
Titration doses: 1
mg
Total dose: 3.5–7.5
mg
i.v.
Initial dose: 0.5–1
mg
Titration doses:
0.5–1 mg
Total dose: <3.