BUVIDAL MONTHLY buprenorphine 160 mg/0.45 mL modified release solution for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine, Quantity: 160 mg

Available from:

Camurus Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: N-methyl-2-pyrrolidone; phosphatidyl choline; glyceryl dioleate; nitrogen

Administration route:

Subcutaneous

Units in package:

A pack contains a single (1) prefilled syringe

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Buvidal Monthly is indicated for maintenance treatment of opioid dependence with prior stabilisation on Buvidal Weekly or sublingual buprenorphine or buprenorphine/naloxone within a framework of medical, social and psychological support.

Product summary:

Visual Identification: A yellowish to yellow clear liquid prolonged-release solution for injection in a pre-filled syringe; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-04-30

Patient Information leaflet

BUVIDAL
® MONTHLY
B
U
V
I
D
A
L
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about being given this medicine, speak to your doctor or
pharmacist.
WARNINGS
RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION
HAZARDOUS AND HARMFUL USE.
LIFE THREATENING RESPIRATORY DEPRESSION
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL
1.
WHY AM I BEING GIVEN BUVIDAL MONTHLY?
Buvidal Monthly contains the active ingredient buprenorphine.
Buprenorphine acts as a substitute for opioids and helps withdrawal.
Buvidal Monthly is used for maintenance treatment of opioid
dependence.
For more information, see Section 1. Why am I being given Buvidal
Monthly? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN BUVIDAL MONTHLY?
Do not use if you have ever had an allergic reaction to Buvidal
Monthly or any of the ingredients listed at the end of the CMI.
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.
TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL
CONDITIONS: kidney disease, liver problems, problems
with excess alcohol use, history of seizures or breathing problems
For more information, see Section 2. What should I know before I am
given Buvidal Monthly? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Buvidal Monthly 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 AM I GIVEN BUVIDAL MONTHLY?
•
Your doctor will prescribe the correct starting dose of Buvidal
Monthly for you. During treatment with Buvidal Monthly, your
doctor may decrease or increase the dose of Buvidal Monthly according
to your needs.
More instructions can be found in Section 4. How am I given Buvidal
Monthly? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN BUVIDAL MONTHLY?
THING

Summary of Product characteristics

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Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
BUVIDAL
® MONTHLY
(BUPRENORPHINE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Buvidal Monthly 64 mg/0.18 mL buprenorphine modified release solution
for injection
Buvidal Monthly 96 mg/0.27 mL buprenorphine modified release solution
for injection
Buvidal Monthly 128 mg/0.36 mL buprenorphine modified release solution
for injection
Buvidal Monthly 160 mg/0.45 mL buprenorphine modified release solution
for injection
_WARNINGS _
_RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION _
SERIOUS HARM OR DEATH COULD RESULT IF ADMINISTERED INTRAVENOUSLY.
BUVIDAL MONTHLY FORMS A GEL DEPOT
UPON CONTACT WITH BODY FLUIDS AND MAY CAUSE OCCLUSION, LOCAL TISSUE
DAMAGE AND THROMBO-EMBOLIC
EVENTS, INCLUDING LIFE THREATENING PULMONARY EMBOLI, IF ADMINISTERED
INTRAVENOUSLY.
_HAZARDOUS AND HARMFUL USE _
ALTHOUGH BUVIDAL MONTHLY 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 BUVIDAL MONTHLY (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 BUVIDAL MONTHLY. 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