ROCURONIUM 50 IV BIOTECH INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Biotech Laboratories (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 5,0 ml VIAL CONTAINS ROCURONIUM BROMIDE 50,0 mg

Authorization status:

Registered

Authorization date:

2018-01-11

Patient Information leaflet

Biotech Laboratories (Pty) Ltd.
1.3.2 Approved PIL
Rocuronium 50 IV Biotech (44/17.1/0188)
Page 1 of 7
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
ROCURONIUM 50 IV BIOTECH, ROCURONIUM BROMIDE
. Each 5 ml vial contains 50 mg rocuronium
bromide. Injection.
ROCURONIUM 50 IV BIOTECH, 10 MG/ML INJECTION
ROCURONIUM BROMIDE
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE ROCURONIUM 50 IV BIOTECH
INJECTION IS ADMINISTERED TO
YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

ROCURONIUM 50 IV BIOTECH has been prescribed for you personally and
you should not share your
medicine with other people.
WHAT IS IN THIS LEAFLET
1. What ROCURONIUM 50 IV BIOTECH is and what it is used for
2. What you need to know before you take ROCURONIUM 50 IV BIOTECH
3. How ROCURONIUM 50 IV BIOTECH will be administered
4. Possible side effects
5. How to store ROCURONIUM 50 IV BIOTECH
6. Contents of the pack and other information
S4
Biotech Laboratories (Pty) Ltd.
1.3.2 Approved PIL
Rocuronium 50 IV Biotech (44/17.1/0188)
Page 2 of 7
1. WHAT ROCURONIUM 50 IV BIOTECH IS AND WHAT IT IS USED
FOR
ROCURONIUM 50 IV BIOTECH is one of a group of medicines called
_muscle relaxants_
. Muscle relaxants
are used during an operation as part of a general anaesthetic. Because
your breathing muscles also relax, you
will need help to breathe (
_artificial ventilation_
) during and after your operation until you can breathe on your
own again.
ROCURONIUM 50 IV BIOTECH can also be used in Intensive Care Units to
keep your muscles relaxed.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROCURONIUM 50 IV BIOTECH
ROCURONIUM 50 IV BIOTECH SHOULD NOT BE ADMINISTERED TO YOU:
- If you are allergic
(hypersensitive) to rocuronium, the bromide ion or any of the other
ingredients of
ROCURONIUM 50 IV BIOTECH.
- If you are pregnant or breastfeeding your baby.
ROCURONIUM 50 IV BIOTECH should not be used in neonates (0 – 1
month); as wel

Summary of Product characteristics

Biotech Laboratories (Pty) Ltd.
1.3.1.1 Approved PI
Rocuronium 50 IV Biotech (44/17.1/0188)
Page 1 of 16
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
ROCURONIUM 50 IV BIOTECH Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 10 mg rocuronium bromide. Each 5 ml vial contains
50 mg rocuronium bromide.
For the full list of excipients, see section 6.1.
Sugar free.
3. PHARMACEUTICAL FORM
Injection.
A clear, colourless to yellow or orange solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ROCURONIUM 50 IV BIOTECH is indicated as an adjunct:

to general anaesthesia to facilitate tracheal intubation during
routine and rapid sequence induction and to
provide skeletal muscle relaxation during surgery.

in the intensive care unit (ICU) to facilitate intubation and
mechanical ventilation for up to 3 days in adults
aged 18 - 65 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage of ROCURONIUM 50 IV BIOTECH should be individualised in
each patient.
Biotech Laboratories (Pty) Ltd.
1.3.1.1 Approved PI
Rocuronium 50 IV Biotech (44/17.1/0188)
Page 2 of 16
The following should be taken into account when determining the dose:
-
method of anaesthesia and the expected duration of surgery,
-
the method of sedation and the expected duration of mechanical
ventilation,
-
the possible interaction with other medication that is administered
concomitantly,
-
the condition of the patient.
The use of an appropriate neuromuscular monitoring technique is
recommended for the evaluation of
neuromuscular block and recovery
Inhalation anaesthetics potentiate the neuromuscular blocking effects
of ROCURONIUM 50 IV BIOTECH.
Potentiation, however, becomes clinically relevant in the course of
anaesthesia, when the volatile agents have
reached
the
tissue
concentrations
required
for
this
interaction.
Consequently,
adjustments
with
ROCURONIUM 50 IV BIOTECH should be made by:
-
administering smaller maintenance doses at less frequent intervals or
-
by using lower infusion rates of ROCURONIUM 50 IV BIOTE