It’s time to rethink defense against RSV.
mRESVIA – now available to help safeguard your patients against LRTD caused by RSV
mRESVIA® (Respiratory Syncytial Virus [RSV] mRNA Vaccine) is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older, and adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV.1
Help protect your patients against LRTD caused by RSV
The only RSV vaccine available in a ready-to-use pre-filled syringe†
Ready for convenient IM administration, once thawed − no reconstitution required.1
Made in Canada*
mRESVIA is manufactured in Laval, QC and Cambridge, ON.
The only mRNA-based RSV vaccine†
mRESVIA stimulates production of RSV A and B neutralizing antibodies and induction of antigen-specific cellular immune responses.1
IM=intramuscular; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.
* With domestic and imported parts.
† Comparative clinical significance unknown.
The mRESVIA pre-filled syringe is ready to use‡ − no reconstitution required1
Dosage and administration overview
Adults aged ≥60 years
Administration | Intramuscularly (IM) As a single dose in the deltoid muscle – do not administer intravenously |
|---|---|
Dose | 50 mcg |
Dose volume | 0.5 mL |
Presentation | Pre-filled Syringe |
Administration | Dose | Dose volume | Presentation |
|---|---|---|---|
Intramuscularly (IM) As a single dose in the deltoid muscle – do not administer intravenously | 50 mcg | 0.5 mL | Pre-filled Syringe |
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
Adults aged 18–59 years at increased risk for LRTD caused by RSV
Administration | Intramuscularly (IM) As a single dose in the deltoid muscle – do not administer intravenously |
|---|---|
Dose | 50 mcg |
Dose volume | 0.5 mL |
Presentation | Pre-filled Syringe |
Administration | Dose | Dose volume | Presentation |
|---|---|---|---|
Intramuscularly (IM) As a single dose in the deltoid muscle – do not administer intravenously | 50 mcg | 0.5 mL | Pre-filled Syringe |
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
‡ Once thawed.
mRESVIA: ready-to-use pre-filled syringes for convenient administration1
mRESVIA is preservative free and comes ready to use once thawed − no reconstitution required. mRESVIA must not be reconstituted, mixed with other medicinal products, or diluted.
Thaw pre-filled syringe
Thaw each pre-filled syringe before use, either in the refrigerator or at room temperature
- The pre-filled syringes may be stored at room temperature for a total of 24 hours after removal from refrigerated conditions
- Discard the pre-filled syringe if not used within this time
- Do not shake
Confirm liquid is white to off-white
Visually inspect mRESVIA pre-filled syringes for particulate matter/discolouration prior to injection
- mRESVIA may contain white or translucent product-related particulates
- Do not administer the vaccine if it is discoloured or contains other particulate matter
Administer mRESVIA
- Use a sterile needle of the appropriate size for IM injection
- With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases; remove tip cap in a slow, steady motion – avoid pulling tip cap while twisting
- Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe
- Uncap the needle when ready for administration
- Administer as a single 0.5 mL dose intramuscularly (IM). The preferred site is the deltoid muscle of the upper arm.
- Discard syringe after use
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
Storage & handling1
For storage, remember “18-90-24”:
Frozen§
up to
18
months
(-40°C to -15°C)
Frozen§
up to
18
months
(-40°C to -15°C)
Refrigerator
(after thawing)
up to
90
days¶
(2°C to 8°C)
Refrigerator
(after thawing)
up to
90
days¶
(2°C to 8°C)
Room Temp
up to
24
hours||
(8°C to 25°C)
Room Temp
up to
24
hours||
(8°C to 25°C)
Thawing Instructions
- Thaw each pre-filled syringe before use
- Pre-filled syringes can be thawed in the refrigerator or at room temperature
In the refrigerator
2°C to 8°C
THAW FOR
100 minutes for one syringe
160 minutes for a carton of 10 syringes
In the refrigerator
2°C to 8°C
THAW FOR
100 minutes for one syringe
160 minutes for a carton of 10 syringes
At room temperature
15°C to 25°C
THAW FOR
40 minutes for one syringe
80 minutes for a carton of 10 syringes
At room temperature
15°C to 25°C
THAW FOR
40 minutes for one syringe
80 minutes for a carton of 10 syringes
NEVER refreeze thawed vaccine
Syringes should not be returned to the refrigerator after being thawed at room temperature
Thawed pre-filled syringes can be handled in room light conditions
Consult the Product Monograph for detailed instructions on dosing, administration, storage and handling.
§ Store in the original carton to minimize exposure to light.
¶ The 90-day period should occur within the overall 18-month expiry period.
|| The 24-hour period should occur within the overall 18-month expiry period.
Looking for a quick overview of mRESVIA administration info?
Looking for a quick overview of mRESVIA administration info?
Access the mRESVIA DASH Guide for a quick reference tool on dosing, administration, and more.
We’re here to help
Get in touch with questions or for any information you may need.
Important information
Indications and clinical use:
mRESVIA® (Respiratory Syncytial Virus [RSV] mRNA Vaccine) is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older, and adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
Pediatrics: safety and efficacy in individuals under 18 years of age have not been established. mRESVIA is not indicated for pediatric use.
Contraindications:
- Hypersensitivity to mRESVIA or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
- Children less than 2 years of age due to an increased risk of severe and/or life-threatening RSV-enhanced respiratory disease reported in infants during a pediatric study. The risk of RSV-enhanced respiratory disease is not applicable to adults.
Relevant warnings and precautions:
- Postpone vaccination in individuals with an acute severe febrile illness
- Syncope
- Anaphylaxis
- Use in individuals with thrombocytopenia or coagulation disorders
- mRESVIA may not protect all vaccine recipients
- Use in immunocompromised individuals
- Not recommended during pregnancy
- Use in breastfeeding individuals
For more information:
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece. The Product Monograph is also available by calling us at 1-866-MODERNA (1-866-663-3762).
Reference
- mRESVIA Product Monograph. Moderna Biopharma Canada Corp.
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