RIVOTRIL clonazepam 1mg/1mL injection ampoule with diluent ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clonazepam, Quantity: 1 mg

Available from:

Pharmaco Australia Ltd

Pharmaceutical form:

Diluent, not applicable

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

5 injection ampoules, 5 diluent ampoules

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

Injection: Intravenous use, for status epilepticus.

Product summary:

Visual Identification: SOLUTION - clear colourless liquid; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-23

Patient Information leaflet

Rivotril
® - Consumer Medicines Information 2021-08 v1.0
1
RIVOTRIL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING RIVOTRIL®?
Rivotril® contains the active ingredient clonazepam. Rivotril® is
used to treat epilepsy in infants, children and adults and it is also
used to treat status epilepticus (prolonged or repeated fits or
seizures without any recovery between attacks).
For more information, see Section 1. Why am I using Rivotril®? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RIVOTRIL®?
Do not use if you have ever had an allergic reaction to clonazepam,
other benzodiazepine medicines or any of the ingredients
listed at the end of the CMI.
Do not use if you have severe and chronic lung disease or severe liver
disease.
Do not use if you have an addiction to drugs or alcohol. This medicine
may be addictive.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Rivotril®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rivotril® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE RIVOTRIL®?

Take Rivotril® exactly as your doctor has prescribed.

Measure the prescribed dose of Rivotril® oral liquid as DROPS ONLY.
More instructions can be found in Section 4. How do I use Rivotril®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RIVOTRIL®?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
Rivotril®.

Do not take any other medicines whether they require a prescription or
not without first telling your
doctor.

Tell your doctor if you become pregnant while taking Rivotril®.

Tell your doctor if, for a

Summary of Product characteristics

2021-08 v1.0
1
AUSTRALIAN PRODUCT INFORMATION
RIVOTRIL (CLONAZEPAM)
1.
NAME OF THE MEDICINE
Clonazepam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rivotril tablets contain 500 micrograms clonazepam.
Rivotril oral liquid contains 2.5 mg/mL clonazepam (one drop contains
0.1 mg clonazepam).
Rivotril concentrated injection solution contains 1 mg clonazepam in 1
mL and is supplied
with 1 mL diluent ampoules containing 1 mL of water for injections.
Excipients with known effect
_Tablet _contains sugars as lactose_ _
_Injection _contains alcohol as 20% v/v ethanol_ _
_Oral liquid _contains saccharin
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
The tablet is a cylindrical, biplanar, pale orange tablet, marked
"0,5" on upper face, and break
bar on reverse face.
The oral liquid is a clear blue homogeneous liquid.
The concentrated injection solution is a clear slightly yellowish
liquid. The diluent is a clear
colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TABLETS
Most types of epilepsy in infants and children, especially absences
(petit mal), myoclonic
seizures and tonic clonic fits, whether due to primary generalised
epilepsy, or to secondary
generalisation of partial epilepsy.
In adults all varieties of generalised epilepsy (including myoclonic,
akinetic, tonic and tonic
clonic seizures), and in partial epilepsy (including psychomotor
seizures).
INJECTION
Intravenous (IV) use, for status epilepticus.
Note: Efficacy by the intramuscular (IM) route has not been
demonstrated.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
WARNING: RIVOTRIL ORAL LIQUID
MEASURE THE PRESCRIBED DOSE OF RIVOTRIL ORAL LIQUID AS DROPS ONLY. DO
NOT
ADMINISTER DROPS DIRECTLY INTO THE MOUTH FROM THE BOTTLE. AFTER EACH
ADMINISTRATION,
ENSURE THAT THE DROPPER IS SECURE IN THE NECK OF THE BOTTLE. DROPS
SHOULD BE GIVEN WITH A
SPOON. AFTER EACH OPENING, MAKE SURE THE DROPPER IS SECURED WITHIN THE
NECK OF THE
BOTTLE.
2021-08 v1.0
2
The dosage of Rivotril must be individually adjusted accord