BIODONE FORTE methadone hydrochloride 5mg/mL oral liquid bottle

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

methadone hydrochloride, Quantity: 5 mg/mL

Dostopno od:

Biomed Aust Pty Ltd

Farmacevtska oblika:

Oral Liquid, solution

Sestava:

Excipient Ingredients: water for injections; Colour

Pot uporabe:

Oral

Enote v paketu:

1000mL, 200mL

Tip zastaranja:

(S8) Controlled Drug

Terapevtske indikacije:

Biodone Forte is indicated for the detoxification and maintenance treatment of dependence on opioid drugs.

Povzetek izdelek:

Visual Identification: Clear, pink to red solution.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status dovoljenje:

Licence status A

Datum dovoljenje:

2000-03-23

Navodilo za uporabo

1
BIODONE FORTE
TM
METHADONE HYDROCHLORIDE 5 MG/ML
CONSUMER MEDICINE INFORMATION (CMI)
WARNINGS
HAZARDOUS AND HARMFUL USE
BIODONE FORTE poses risks of abuse and misuse which can lead to
overdose and death. Your doctor will
monitor you regularly during your treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
BIODONE FORTE can cause life-threatening or fatal breathing problems
(slow, shallow, unusual or no breathing)
even when used as recommended. These problems can occur at any time
during use, but the risk is higher when
first starting BIODONE FORTE and after a dose increase, if you are
older, or have an existing problem with your
lungs. Your doctor will monitor you.
USE OF OTHER MEDICINES WHILE USING BIODONE FORTE
USING BIODONE FORTE WITH OTHER MEDICINES THAT CAN MAKE YOU FEEL DROWSY
SUCH AS SLEEPING TABLETS (E.G.
BENZODIAZEPINES), OTHER PAIN RELIEVERS, ANTIHISTAMINES,
ANTIDEPRESSANTS, ANTIPSYCHOTICS, GABAPENTINOIDS
(E.G. GABAPENTIN AND PREGABALIN), CANNABIS AND ALCOHOL MAY RESULT IN
SEVERE DROWSINESS, DECREASED
AWARENESS, BREATHING PROBLEMS, COMA AND DEATH. Your doctor will
monitor you for signs and symptoms of
breathing difficulties and sedation. You must not drink alcohol while
using BIODONE FORTE.
WHAT IS IN THIS LEAFLET
This leaflet provides a summary of information about BIODONE FORTE.
Please read it carefully before you use
this product. Keep this leaflet. You may need to read it again.
WHERE TO GO FOR FURTHER INFORMATION:
This information has been provided to help you understand how BIODONE
FORTE works. If you have any
questions or are not sure about anything please ask your doctor or
pharmacist. More detailed technical information
is included in the Product Information available to the medical
profession.
WHAT IT IS USED FOR
BIODONE FORTE has been approved for use in treating people with a
dependency on opioid analgesic drugs.
The active ingredient in BIODONE FORTE is methadone hydrochloride.
This belongs to the class of drugs known
as opioid analgesics.
DEPENDENCE
As with all other opioid containing pro

Lastnosti izdelka

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AUSTRALIAN PRODUCT INFORMATION – BIODONE FORTE
(METHADONE HYDROCHLORIDE) ORAL SOLUTION
WARNINGS
_HAZARDOUS AND HARMFUL USE _
Although Biodone Forte is indicated for the treatment of opioid
dependence it still poses risks
of hazardous and harmful use which can lead to overdose and death.
Monitor the patient’s
ongoing risk of hazardous and harmful use regularly during opioid
substitution therapy with
Biodone Forte (see section 4.4. Special Warnings and Precautions for
Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life
‐
threatening or fatal respiratory depression may occur with the use of
Biodone Forte. Be aware of situations which increase the risk of
respiratory depression, and
monitor patients closely, especially on initiation or following a dose
increase (see section 4.4
Special Warnings and Precautions for Use).
_CONCOMITANT _
_USE _
_OF _
_BENZODIAZEPINES _
_AND _
_OTHER _
_CENTRAL _
_NERVOUS _
_SYSTEM _
_(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants,
antipsychotics,
cannabis
or
other
central
nervous
system
(CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Patients and their caregivers should be made aware of
the symptoms of
respiratory depression. Patients and their caregivers should also be
informed of the potential
harms of consuming alcohol while taking Biodone Forte.
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NAME OF THE MEDICINE
Methadone hydrochloride
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral liquid containing methadone hydrochloride 5 mg/mL.
For the full list of excipients, see Section 6.1- List of excipients.
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PHARMACEUTICAL FORM
Methadone hydrochloride is a synthetic opioid analgesic with the
general properties of
morphine.
It occurs as odourless, colourless crystals or white crystalline
powder. It is soluble in water,
freely soluble in alcohol and chloroform, particularly insoluble in
ether and in glycerol.
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4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC I