ZYAMIS midazolam (as maleate) 7.5 mg/0.75 mL oromucosal solution pre-filled oral syringe

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

midazolam maleate, Quantity: 10.2 mg (Equivalent: midazolam, Qty 7.5 mg)

제공처:

Clinect Pty Ltd

약제 형태:

Solution

구성:

Excipient Ingredients: ethanol; saccharin sodium; glycerol; purified water; sodium hydroxide; maltitol

관리 경로:

Buccal

패키지 단위:

single oral syringe

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

ZYAMIS, as buccal midazolam, is indicated for the treatment of Generalised Convulsive Status Epilepticus (GCSE), in those over 6 months old.

제품 요약:

Visual Identification: Midazolam (as maleate) 7.5 mg/0.75 mL oromucosal solution appears as a slightly viscous, clear, colourless to pale yellow liquid. , The label on the syringe and the tamper evident container of 7.5 mg/0.75 mL strength is coloured purple; Container Type: Syringe; Container Life Time: 14 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2022-04-22

환자 정보 전단

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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 a doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY IS THE PATIENT USING ZYAMIS?
ZYAMIS contains the active ingredient midazolam (as maleate). ZYAMIS
is used to stop generalised convulsive seizures ('fit') in
patients over 6 months old. ZYAMIS must only be used by
parents/caregivers where the patient has an established diagnosis of
epilepsy by a medical practitioner. For more information, see Section
1. Why is the patient using ZYAMIS? in the full CMI.
2.
WHAT THE PATIENT OR CARER SHOULD KNOW BEFORE USING ZYAMIS
Do not use if the patient has ever had an allergic reaction to
midazolam or any of the ingredients listed at the end of the CMI.
Talk to your patient’s doctor if your patient has any other medical
conditions, takes any other medicines, or is pregnant or plans
to become pregnant or is breastfeeding. For more information, see
Section 2. What you or your patient should know before using
ZYAMIS in the full CMI.
3.
WHAT IF THE PATIENT IS TAKING OTHER MEDICINES?
Some medicines may interfere with ZYAMIS and affect how it works. A
list of these medicines is in Section 3. What if the patient is
taking other medicines? in the full CMI.
4.
HOW DO I USE ZYAMIS FOR MY PATIENT?
•
The dose is based on the age and weight range. More instructions can
be found in Section 4. How do I use ZYAMIS for my
patient? in the full CMI.
5.
WHAT SHOULD YOU KNOW WHILE USING ZYAMIS?
THINGS YOU
SHOULD DO
•
Remind any doctor, pharmacist or dentist you visit that the patient is
using ZYAMIS.
•
In the event of a seizure, the parent or caregiver must follow the
instructions in the patient’s Emergency
Medication Management Plan.
THINGS YOU
SHOULD NOT DO
•
Do not give more than one dose without prior medical advice.
DRIVING
OR USING
MACHINES
•
After receivin

제품 특성 요약

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification
of new safety information. Healthcare professionals are asked to
report any suspected adverse events
at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION –
ZYAMIS (MIDAZOLAM) OROMUCOSAL
SOLUTION
1.
NAME OF THE MEDICINE
Midazolam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZYAMIS midazolam 2.5 mg/0.25 mL oromucosal solution.
Each pre-filled, oral syringe (0.25 mL) contains midazolam maleate
equivalent to 2.5 mg midazolam per 0.25
mL solution.
ZYAMIS midazolam 5 mg/0.5 mL oromucosal solution.
Each pre-filled, oral syringe (0.5 mL) contains midazolam maleate
equivalent to 5 mg midazolam per 0.5 mL
solution.
ZYAMIS midazolam 7.5 mg/0.75 mL oromucosal solution.
Each pre-filled, oral syringe (0.75 mL) contains midazolam maleate
equivalent to 7.5 mg midazolam per 0.75
mL solution.
ZYAMIS midazolam 10 mg/1 mL oromucosal solution.
Each pre-filled, oral syringe (1 mL) contains midazolam maleate
equivalent to 10 mg midazolam per 1 mL
solution.
Excipients with known effect include ethanol, saccharin sodium and
maltitol solution.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Oromucosal solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZYAMIS, as buccal midazolam, is indicated for the treatment of
Generalised Convulsive Status Epilepticus
(GCSE), in those over 6 months old.
2
4.2 DOSE AND METHOD OF ADMINISTRATION
The initial prescription must be initiated by a specialist physician
experienced in the treatment of epilepsy.
ZYAMIS, when used by parents/caregivers, must only be used where the
patient has been diagnosed by a
medical practitioner to have epilepsy.
The medicine contains no preservatives. The medicine is for single use
in one patient only.
The standard doses are summarised in the table below:
TABLE 1: PROPOSED DOSE OF ZYAMIS (MIDAZOLAM)
Age Range
Weight Range
Dose
> 6 months to < 1 year
7 to <12 kg
2.5 mg
1 year to < 5 years
12 kg t