Midazolam Injection Solution for injection 5mg/ml

País: Tanzania

Idioma: inglés

Fuente: Tanzania Medicinces & Medical Devices Authority

Ingredientes activos:

Midazolam Injection BP 5 mg/ml

Disponible desde:

Intas Pharmaceuticals Limited, INDIA

Código ATC:

Hypnotics and sedatives drugs

Designación común internacional (DCI):

Midazolam Injection BP 5 mg/ml

Dosis:

5mg/ml

formulario farmacéutico:

Solution for injection

Fabricado por:

Intas Pharmaceuticals Limited, INDIA

Resumen del producto:

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)

Estado de Autorización:

Registered/Compliant

Fecha de autorización:

2022-12-05

Ficha técnica

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.