Rivotril

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Clonazepam 2.5 mg/mL; Clonazepam 2.5 mg/mL

Saadav alates:

Pharmaco (NZ) Ltd

INN (Rahvusvaheline Nimetus):

Clonazepam 2.5 mg/mL

Annus:

2.5 mg/mL

Ravimvorm:

Oral solution

Koostis:

Active: Clonazepam 2.5 mg/mL Excipient: Acetic acid Peach flavour PHL-014725 Propylene glycol Saccharin sodium Active: Clonazepam 2.5 mg/mL Excipient: Acetic acid Brilliant blue FCF Peach flavour PHL-014725 Propylene glycol Saccharin sodium

Ühikuid pakis:

Bottle, glass, with dropper, 10 mL

Klass:

Class C5 Controlled Drug

Retsepti tüüp:

Class C5 Controlled Drug

Valmistatud:

DSM Nutritional Products Ltd

Näidustused:

Most clinical forms of epilepsy in infants and children, in particular typical and atypical absences (Lennox-Gastaut syndrome), nodding spasms, primary or secondary generalised tonic-clonic seizures. In adults, Rivotril may be used in all varieties of generalised epilepsy (including absence, myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial (focal) epilepsy (including psychomotor seizures).

Toote kokkuvõte:

Package - Contents - Shelf Life: Bottle, glass, with dropper - 10 mL - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

1976-05-12

Infovoldik

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Rivotril CMI 08082022
1
NEW ZEALAND CONSUMER MEDICINE INFORMATION
RIVOTRIL
®
CLONAZEPAM: ORAL DROPS (2.5 MG/ML).
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using RIVOTRIL.
This leaflet answers some common questions about RIVOTRIL. It does not
contain all the available
information. It does not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using RIVOTRIL
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT RIVOTRIL IS USED FOR
RIVOTRIL drops are used for the treatment of epilepsy (fits) in
infants, children and adults.
RIVOTRIL belongs to a group of medicines called benzodiazepines. They
are thought to work by their
action on brain chemicals.
Your doctor, however, may have prescribed RIVOTRIL for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY RIVOTRIL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor’s prescription.
RIVOTRIL can be habit forming (leading to
addiction). The risks are greater for patients on higher doses or on
long term treatment, or patients
who have a history of alcohol or drug abuse.
BEFORE YOU USE RIVOTRIL
_WHEN YOU MUST NOT USE IT _
DO NOT USE RIVOTRIL IF:
1.
YOU HAVE HAD AN ALLERGIC REACTION TO RIVOTRIL, OR ANY INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET
Some symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty in breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin
2.
YOU HAVE SEVERE AND CHRONIC LUNG DISEASE
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_ _
Rivotril CMI 08082022
2
3.
YOU HAVE SEVERE LIVER DISEASE
4.
YOU HAVE SLEEP APNOEA, A CONDITION WHERE YOUR BREATHING STOPS FOR
SHORT PERIOD WHILST YOU
ARE ASLEEP
5.
YOU HAVE AN ADDICTION TO DRUGS OR ALCOHOL
6.
THE PACKAGE IS TORN OR SHOWS SIGNS OF TAMPERING

Toote omadused

NEW ZEALAND DATA SHEET
Rivotril 2022-08
1
1.
PRODUCT NAME
Rivotril
®
2.5 mg/mL oral solution (drops)
Caution: Never administer Rivotril drops directly into the mouth from
the bottle.
After each opening, make sure the dropper is secured within the neck
of the bottle.
ANTIEPILEPTIC AGENT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Drops:_ 2.5 mg/mL (1 drop contains 0.1 mg clonazepam).
EXCIPIENTS WITH KNOWN EFFECT
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Rivotril 2.5 mg/mL oral solution (drops) are available as a clear,
blue or colourless to slightly
green-yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rivotril is indicated for most clinical forms of epilepsy in infants
and children, in particular
typical and atypical absences (Lennox-Gastaut syndrome), nodding
spasms, primary or
secondary generalised tonic-clonic seizures.
In adults, Rivotril may be used in all varieties of generalised
epilepsy (including absence,
myoclonic, akinetic, tonic and tonic-clonic seizures), and in partial
(focal) epilepsy (including
psychomotor seizures).
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage of Rivotril must be individually adjusted according to the
patient’s clinical
response, tolerance of the medicine and the patient’s age.
Before adding Rivotril to an existing anticonvulsant regimen, it
should be considered that the
use of multiple anticonvulsants may result in an increase of
undesirable effects.
To ensure optimum dosage adjustment, infants and children up to the
age of 10 years should
be given the drops. The drops can also be used for titration.
NEW ZEALAND DATA SHEET
Rivotril 2022-08
2
A single oral dose of Rivotril begins to take effect within 30 - 60
minutes and remains
effective for 6 - 8 hours in children and 8 - 12 hours in adults.
DOSE
To avoid adverse reactions at the beginning of therapy, it is
essential to start treatment with
Rivotril at a low dose and increase the daily dose progressively until
the maintenance dose
suited to the individual patient