Mosby's 2014 Nursing Drug Reference (372 page)

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No reconstitution needed; before use, swirl the contents of the vial with a gentle rotary motion, do not shake; the solution should be clear

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Store unopened vials refrigerated, do not freeze, protect from light; once opened, the vial may be stored refrigerated ≤14 days

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This product is supplied as a powder, filled in a two-chamber cartridge with the active substance in the front chamber and the diluent in the rear chamber; the product is available in a 5-mg cartridge (green tip) and a 12-mg cartridge (purple tip); the 5- and 12-mg cartridges may be used with the Genotropin Pen or the Genotropin Mixer; genotropin is also available, in various doses ranging from 0.2 mg to 2 mg, in single use, auto-mix devices called Genotropin Miniquicks

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Cartridges:
Store cartridges refrigerated before reconstitution, do not freeze; protect from light; a reconstitution device supplied by the manufacturer is used to mix the powder and the diluent; after the powder and diluent are mixed, gently tip the cartridge upside down a few times until powder is completely dissolved;
do not shake;
this can cause denaturation of the protein; if the solution is cloudy, do not use; following reconstitution, the 5-mg cartridge contains a 5 mg/ml solution and the 12 mg cartridge contains a 12 mg/ml solution; the 5-mg and 12-mg cartridges contain overfill; the cartridges contain diluent with preservative (m-cresol) and may be stored refrigerated ≤28 days after reconstitution; do not use the 5-mg and 12-mg cartridges in patients with m-cresol hypersensitivity

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Genotropin Minquicks:
After dispensing but before reconstitution, store at ≤77 degrees ≤3 months; a reconstitution device supplied by the manufacturer is used to mix the powder and diluent; ten different strengths are available that each deliver a fixed volume of 0.25 ml; this product contains a diluent with no preservative, refrigerate after reconstitution and use within 24 hr; use the reconstituted solution only once and discard any remaining solution

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Before reconstitution, store refrigerated

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Vials:
Reconstitute each 5-mg vial with 1.5–5 ml of the supplied diluent (contains m-cresol as a preservative) or bacteriostatic water for injection (contains benzoyl alcohol as a preservative); sterile water for injection may be used for patients with a hypersensitivity to m-cresol and benzoyl alcohol; direct the liquid against the glass vial wall; swirl vial with a gentle rotary motion until contents are dissolved completely; do not shake; if the solution is cloudy, do not use; small, colorless particles may be present after refrigeration, this is not unusual for solutions containing proteins; vials reconstituted with the diluent or bacteriostatic water are stable for 14 days when stored refrigerated; for vials reconstituted with sterile water, use the vial only once and discard the unused portion; if not used immediately, refrigerate and use within 24 hr; avoid freezing reconstituted solutions

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Cartridges:
Reconstitute cartridges using
only
the supplied diluent syringe; the cartridges are designed for use only with the Humatrope injection device; once reconstituted, the cartridges are stable for up to 28 days when stored refrigerated; store the injection device without the needle attached; avoid freezing reconstituted solutions

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Do not use reconstituted solution if it is cloudy or contains particulate matter

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Before use, store refrigerated

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Reconstitution of the cartridges is not required; the cartridge is intended for use only with the NordiPen injector; a prefilled, disposable pen, NordiFlex Pen injector, is also available; each cartridge size (5 mg, 10 mg, or 15 mg per 1.5-ml cartridge) has a color-coded corresponding pen, which is graduated to deliver an appropriate dose based on the solution’s concentration; NordiPen and NordiFlex Pen allow administration of a minimum 0.25-mg dose to a maximum 4.5-mg dose, depending on cartridge concentrations; follow directions provided in NordiPen injector instruction booklet

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After a cartridge has been inserted into the NordiPen injector or once a NordiFlex pen is in use, the pen should be stored refrigerated and used within 4 wk; alternatively, the 5-mg and 10-mg cartridges may be stored in the pen at room temperature, no higher than 77 degrees, for up to 3 wk; NovoFine needles are recommended for administration; wipe the stopper of the pen cartridge with rubbing alcohol

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Before reconstitution, store refrigerated

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Reconstitute each 5-mg vial with 1–5 ml bacteriostatic water for injection (benzyl alcohol preserved) and each 10-mg vial with 1–10 ml of bacteriostatic water for injection (benzyl alcohol preserved); if using for newborns, reconstitute with sterile water for injection; direct the liquid against the glass vial wall; swirl vial with a gentle rotary motion until contents are dissolved completely; do not shake; if the solution is cloudy after reconstitution or refrigeration, do not use; small, colorless particles may be present after refrigeration, this is not unusual for solutions containing proteins

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Solutions reconstituted with bacteriostatic water for injection are stable for 14 days refrigerated

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Solutions reconstituted with sterile water for injection should be used immediately and only once; discard any unused portions; avoid freezing reconstituted solutions

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Does not require reconstitution; solution should be clear; small, colorless particles may be present after refrigeration, this is not unusual for solutions containing proteins; allow vial or pen cartridge to come to room temperature, and gently swirl; if solution is cloudy, do not use

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Vials:
Before inserting needle, wipe the vial septum with rubbing alcohol or antiseptic solution to prevent contamination by microorganisms that may be introduced by repeated needle insertions; administer using sterile disposable syringes and needles; use syringes with small enough volume that the prescribed dose may be drawn from the vial with reasonable accuracy

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Pen cartridge:
Two strengths are available, 10 mg and 20 mg; intended for use only with Nutropin AQ Pen; each pen and cartridge are color coded to ensure accurate placement of the 10-mg or 20-mg cartridge into the appropriate pen; do not use the 20-mg cartridge in the pen intended for the 10-mg cartridge, and vice versa; wipe septum of pen cartridge with rubbing alcohol or antiseptic solution to prevent contamination by microorganisms that may be introduced by repeated needle insertions; administer using sterile, disposable needles; follow the directions provided in the Nutropin AQ Pen Instructions for Use; the Nutropin AQ 10 pen allows administration of a minimum 0.1-mg dose to a maximum 4-mg dose, in 0.1-mg increments; the Nutropin AQ 20 pen allows administration of a minimum 0.2-mg dose to a maximum 8-mg dose, in 0.2-mg increments

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Prefilled device:
A prefilled multidose, dial-a-dose device is available in 3 strengths; administer using disposable needles; follow the directions provided in the Nutropin AQ NuSpin Instructions for Use; the Nutropin AQ Nuspin 5 allows administration of a minimum dose of 0.05 mg to a maximum dose of 1.75 mg, in increments of 0.05 mg; the Nutropin
AQ Nuspin 10 allows administration of a minimum dose of 0.1 mg to a maximum dose of 3.5 mg, in increments of 0.1 mg; the Nutropin AQ Nuspin 20 allows administration of a minimum dose of 0.2 mg to a maximum dose of 7 mg, in increments of 0.2 mg

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After initial use, vials, cartridges, and prefilled devices are stable for 28 days refrigerated; avoid freezing; vials, cartridges, and prefilled devices are light sensitive; protect from light

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Before reconstitution, store vials refrigerated; store in the carton; Omnitrope is sensitive to light

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Vials:
Reconstitute the vial with diluent provided using a sterile disposable syringe; swirl the vial gently, but do not shake; if the solution is cloudy after reconstitution, the contents must not be injected; after reconstitution, the 1.5-mg vial may be refrigerated ≤24 hr; the 1.5-mg vial does not contain a preservative and should only be used once; discard any remaining solution; the 5.8-mg vial diluent contains benzoyl alcohol as a preservative; after reconstitution, the contents must be used within 3 wk; after the first injection, store the 5.8-mg vial in the carton, to protect from light, in the refrigerator; avoid freezing

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Omnitrope Pen 5 cartridge:
Each 5-mg cartridge must be inserted into the Omnitrope Pen 5 delivery system; follow the directions provided in the Omnitrope Instructions for Use; the cartridge contains benzoyl alcohol as a preservative; after the first use, store refrigerated ≤28 days; protect from light, avoid freezing

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Omnitrope Pen 10 cartridge:
Each 10-mg cartridge must be inserted into the Omnitrope Pen 10 delivery system; follow the directions provided in the Omnitrope Instructions for Use; after the first use, store refrigerated ≤28 days; protect from light, avoid freezing

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Before reconstitution, store at room temperature

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Vials:
Reconstitute each 5-mg vial with 1–3 ml bacteriostatic water for injection; reconstitute each 8.8-mg vial with 2–3 ml bacteriostatic water for injection (benzoyl alcohol preserved); in patients with hypersensitivity to benzyl alcohol, the vials may be mixed with sterile water for injection; Direct the liquid against the glass vial wall; swirl vial with a gentle rotary motion until contents are dissolved completely; do not shake; the solution should be clear; if it is cloudy immediately after reconstitution or refrigeration, do not use; small colorless particles may be present after refrigeration, this is not unusual for solutions containing proteins; after reconstitution, store vials mixed with bacteriostatic water for injection refrigerated and use within 14 days; for vials mixed with sterile water for injection, the solution should be used immediately, and any unused portion should be discarded; avoid freezing

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Cartridges:
Available in 4 mg and 8.8 mg click.easy cartridges for use in a compatible injection device; a reconstitution device supplied by the manufacturer is used to mix the Saizen with accompanying diluent containing metacresol; cartridges reconstituted with the diluent containing metascresol are stable under refrigeration for ≤21 days; avoid freezing

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Before reconstitution, store vials and diluent at room temperature (15–30 degrees C; 59–86 degrees F)

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Vials:
Reconstitute the 5-mg or 6-mg vials with 0.5–1 ml of supplied diluent (sterile water for injection); reconstitute the 4-mg vial with 0.5–1 ml of bacteriostatic water for injection (benzoyl alcohol preserved) and the 8.8-mg vial with 1–2 ml of bacteriostatic water for injection (benzoyl alcohol preserved); direct the liquid against the glass vial wall; swirl vial with a gentle rotary motion until contents are dissolved completely; do not shake; the solution should be clear; if it is cloudy immediately after reconstitution
or refrigeration, do not use; small colorless particles may be present after refrigeration, this is not unusual for solutions containing proteins; if reconstituted with sterile water for injection, use within 24 hr; if reconstituted with bacteriostatic water for injection (benzoyl alcohol preserved), the solution is stable for up to 14 days under refrigeration (2–8 degrees C or 36–46 degrees F); avoid freezing

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Cartridges:
Available in 8.8-mg click.easy cartridges for use in a compatible injection device; a reconstitution device is supplied by the manufacturer and is used to mix the Serostim with accompanying diluent containing metacresol; after reconstitution, cartridges are stable under refrigeration for ≤21 days; avoid freezing

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Before use, store refrigerated

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Available in 6-mg single-use cartridges that do not require reconstitution; administer using sterile disposable syringes and needles

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Bring to room temperature before use; discard single-use cartridge after use, even if some drug remains; discard cartridges after the expiration date stated on the product; do not freeze; protect from light

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Before reconstitution, store refrigerated

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Reconstitute each 5-mg vial with 1–5 ml bacteriostatic 0.9% sodium chloride (benzoyl alcohol preserved) for injection; direct the liquid against the glass vial wall; swirl vial with a gentle rotary motion until contents are dissolved completely; do not shake; the solution should be clear; if it is cloudy immediately after reconstitution, do not inject; small, colorless particles may be present after refrigeration, this is not unusual for solutions containing proteins; when administering to newborns, reconstitute with sterile normal saline for injection that is unpreserved

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Solution reconstituted with bacteriostatic 0.9% sodium chloride is stable for 14 days when stored refrigerated; solution reconstituted with sterile normal saline should be used only once; discard any remaining solution; avoid freezing

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Before dispensing, store vials and diluent refrigerated; after dispensing to patients, may be stored at or below 77 degrees F for up to 3 mo

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Reconstitute each 5-mg vial with the entire contents of the accompanying diluent, which contains metacresol as a preservative; if patients are allergic to metacresol, sterile water for injection may be used; direct the liquid against the glass vial wall; swirl vial with a gentle rotary motion until contents are dissolved completely; do not shake; the solution should be clear, if it is cloudy or contains particulate matter immediately after reconstitution or after refrigeration, do not inject; the final concentration of the reconstituted solution is 3.33 mg/ml

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After reconstitution with the provided diluent, solutions may be stored refrigerated for up to 14 days; after reconstitution with sterile water for injection, use only one dose of Valtropin per vial and discard the unused portion if not used immediately