RONAPREVE casirivimab 120mg/ml and imdevimab 120mg/ml solutions for infusion or injection in 1332 mg multi dose vials

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

imdevimab, Quantity: 120 mg/mL

Tersedia dari:

Roche Products Pty Ltd

Bentuk farmasi:

Injection, solution

Komposisi:

Excipient Ingredients: histidine; histidine hydrochloride monohydrate; sucrose; polysorbate 80; water for injections

Rute administrasi :

Intravenous Infusion, Subcutaneous

Unit dalam paket:

20 mL multidose vials

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Ronapreve has provisional approval for the indications below:,Treatment:,Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19.,Post-exposure prophylaxis:,Ronapreve is indicated for the prevention of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40 kg) who have been exposed to SARS-CoV-2 AND who either:,? have a medical condition making them unlikely to respond to or be protected by vaccination, OR,? are not vaccinated against COVID-19. (,refer to section 4.2 Dose and method of administration and section 5.1, Clinical Trials),Ronapreve is not intended to be used as a substitute for vaccination against COVID-19.,The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.,The use of Ronapreve should take into account information on the activity of Ronapreve against viral variants of concern. See sections 4.4 and 5.1.

Ringkasan produk:

Visual Identification: 20 ml glass vial containing clear to slightly opalescent and colourless to pale yellow solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Status otorisasi:

Registered (Provisional)

Tanggal Otorisasi:

2021-10-18

Selebaran informasi

RONAPREVE
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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 your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I BEING GIVEN RONAPREVE?
RONAPREVE contains the active ingredients casirivimab and imdevimab.
RONAPREVE is used in patients 12 years and older and
weighing at least 40 kg to:
•
treat COVID-19 in those who are at an increased risk of progressing to
severe disease, or
•
prevent COVID-19 post-exposure, in those who are unlikely to be
protected by a COVID-19 vaccine.
For more information, see Section 1. Why am I being given RONAPREVE?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN RONAPREVE?
You must not be given RONAPREVE if you have ever had an allergic
reaction to casirivimab and imdevimab or any of the
ingredients listed at the end of this CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant, plan to become pregnant or
are breastfeeding.
For more information, see Section 2. What should I know before I am
given RONAPREVE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that you buy
without a prescription from your pharmacy, supermarket or health food
shop.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS RONAPREVE GIVEN?
TREATMENT: RONAPREVE is given either as a single infusion into the
vein (intravenous infusion) or an injection under the skin
(subcutaneous injection) after a positive test for the SARS-COV-2
virus.
PREVENTION: RONAPREVE is given by either intravenous infusion or a
subcutaneous injection. It can be given as a single dose
following exposure to SARS-COV-2 or it can be repeated once every 4
weeks if required.
Mor

Karakteristik produk

Ronapreve 20221125
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 https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
RONAPREVE
® (CASIRIVIMAB AND IMDEVIMAB)
1.
NAME OF THE MEDICINE
Casirivimab and imdevimab
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ronapreve is available as:
a. Co-packaged 6 mL single-use vials
Each casirivimab 6 mL vial contains 300 mg of casirivimab per 2.5 mL
(120 mg/mL).
Each imdevimab 6 mL vial contains 300 mg imdevimab per 2.5 mL (120
mg/mL).
b. Co-packaged 20 mL multidose vials
Each casirivimab 20 mL multidose vial contains 1 332 mg of casirivimab
per 11.1 mL (120
mg/mL).
Each imdevimab 20 mL multidose vial contains 1 332 mg imdevimab per
11.1 mL (120 mg/mL).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear to slightly opalescent and colourless to pale yellow solution
with a pH of 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ronapreve has PROVISIONAL APPROVAL
for the indications below:
TREATMENT
Ronapreve is indicated for the treatment of COVID-19 in adults and
adolescents (aged 12 years
and older and weighing at least 40 kg) who do not require supplemental
oxygen for COVID-19
and who are at increased risk of progressing to severe COVID-19.
POST-EXPOSURE PROPHYLAXIS
Ronapreve is indicated for the prevention of COVID-19 in adults and
adolescents (aged 12 years
and older and weighing at least 40 kg) who have been exposed to
SARS-CoV-2 AND who either:
•
have a medical condition making them unlikely to respond to or be
protected by
vaccination, OR
•
are not vaccinated against COVID-19.
(refer to section 4.2 Dose and method of administration and section
5.1, Clinical Trials)
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
Ronapreve 20221125
2
Ronapreve is not intended to be used as a substitute for vaccination
against COVID-19.
The decision ha