Source: Health Products and Food Branch (CA) Revision Year: 2015
EGRIFTA.
| Route of Administration | Dosage Form / Strength | Clinically Relevant Nonmedicinal Ingredients |
|---|---|---|
| Subcutaneous injection | Lyophilized powder for injection / 1 mg tesamorelin, as tesamorelin acetate, per vial | None |
| Subcutaneous injection | Lyophilized powder for injection / 2 mg tesamorelin, as tesamorelin acetate, per vial | None |
EGRIFTA is available in single-dose strengths of 1 mg and 2 mg vials supplied in packages comprised of 1 month supply:
1 mg Vials:
Box 1 of 2: Medication box with 60 vials containing (each) 1 mg of tesamorelin.
Box 2 of 2: Injection kit box contains: 30 single-use vials of Sterile Water for Injection, 30 3cc syringes equipped with a 1½“ 18-gauge reconstitution needle. Other needles supplied: 30 1 ½” 18-gauge sterile needles for mixing and 30 ½" 27-gauge injection needles.
Two 1 mg vials of EGRIFTA per day are required for a 2 mg dose.
EGRIFTA is supplied as a sterile, non-pyrogenic lyophilized powder.
Each vial contains 1 mg of tesamorelin, as tesamorelin acetate, 50 mg mannitol, sodium hydroxide and/or hydrochloric acid for pH adjustment.
The stopper does not contain latex.
2 mg Vials:
Box 1 of 2: Medication box with 30 vials containing (each) 2 mg of tesamorelin.
Box 2 of 2: Injection kit box contains: 30 single-use vials of Sterile Water for Injection, 30 3cc syringes equipped with a 1½“ 18-gauge reconstitution needle. Other needles supplied: 30 ½” 27- gauge injection needle.
One 2 mg vial of EGRIFTA per day is required for a 2 mg dose.
EGRIFTA is supplied as a sterile, non-pyrogenic lyophilized powder. Each vial contains 2 mg of tesamorelin, as tesamorelin acetate, 100 mg mannitol, sodium hydroxide and/or hydrochloric acid for pH adjustment.
The stopper does not contain latex.
| Marketing Informations | Authorization Dates |
|---|---|
|
Authorization holder:
Theratechnologies Inc., 2015 Peel St. 5th Floor, Montreal, QC, Canada, H3A 1T8, www.theratech.com 177087 |
Date of revision:
March 26, 2015 |
| Drug | Countries | |
|---|---|---|
| EGRIFTA | Canada, United States |
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