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GENOTROPIN (somatropin [rDNA origin] for injection) Dosage Forms, Composition And Packaging

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Dosage Forms, Composition And Packaging

Availability of Dosage Forms

GENOTROPIN GoQuick:

Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (with preservative)
The 5 mg pre-filled pen GoQuick is colour coded green.
The 5.3 mg pre-filled pen GoQuick is colour coded blue.
The 12 mg pre-filled pen GoQuick is colour coded purple.

5.0, 5.3 and 12 mg: Packages of 1s and Packages of 5s

Not all pack sizes and strengths may be marketed in Canada.

GENOTROPIN MiniQuick:

Growth Hormone Delivery Device containing a two-chamber cartridge of GENOTROPIN (without preservative)

1.2, 1.6, 1.8 and 2.0 mg: Packages of 4s
0.2, 0.4, 0.6, 0.8, 1.0, 1.2, 1.4, 1.6, 1.8, and 2.0 mg: Packages of 7s and Packages of 28 (4 x 7 Packages)

Not all package sizes and strengths may be marketed in Canada.

Please see directions for use accompanying each delivery device.

Composition

GENOTROPIN (somatropin for injection) is a sterile white lyophilized powder containing (or of) highly purified rhGH, intended for subcutaneous injection.

The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7. The concentration of the reconstituted solution varies by strength and presentation.

GENOTROPIN GoQuick:

Powder and 1.14 ml liquid in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap and at the other end by a rubber stopper (bromobutyl). The two-chamber cartridge is supplied for use in a disposable multidose pre-filled pen. The 5 mg, 5.3mg and 12 mg presentations of GENOTROPIN GoQuick lyophilized powder contain m-cresol as a preservative. These products should not be used by patients with a known sensitivity to this preservative.

GENOTROPIN MiniQuick:

Powder and 0.275 - 0.282 ml liquid in a two chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl), supplied as a single dose syringe. The cartridge is sealed at both ends with rubber stoppers (bromobutyl) and is enclosed in a plastic sleeve with a plunger rod and a finger grip. The GENOTROPIN MiniQuick presentations are preservative-free.

Composition of the Genotropin MiniQuick After Reconstitution

Dosage Form

Quantity per Syringe

GENOTROPIN MiniQuick

0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, and 2.0 mg/syringe

0.22 mg - 2.26 mg Somatropin for Injection

0.23 - 0.24 mg glycine

13.8 - 14.1 mg mannitol

0.050 - 0.051 mg sodium dihydrogen phosphate anhydrous

0.027 - 0.028 mg disodium phosphate anhydrous

to 0.28 mL Water for injection

Composition of the Genotropin GoQuick After Reconstitution

Dosage Form

Quantity per mL

GENOTROPIN GoQuick

5 mg/pen

5.3 mg/pen

5.0 -5.3 mg Somatropin for Injection

2 mg glycine

41 mg mannitol

0.29 mg sodium dihydrogen phosphate anhydrous

0.28 mg disodium phosphate anhydrous

3 mg metacresol

to 1 mL Water for injection

GENOTROPIN GoQuick

12 mg/pen

12.0 mg Somatropin for Injection

2 mg glycine

40 mg mannitol

0.41 mg sodium dihydrogen phosphate anhydrous

0.40 mg disodium phosphate anhydrous

3 mg metacresol

to 1 mL Water for injection

 

Control #: 233398
7 February 2020

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