A4145 Spinal 22g Whitacre label

A4145 Spinal 22g Whitacre

A4145 Spinal 22g Whitacre Recall

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Side Effects & Adverse Reactions

Not for human use. Keep this and all drugs out of the reach of children.

Not for human use. Keep this and all drugs out of the reach of children.

Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with COMFORTIS (see POST APPROVAL EXPERIENCE).

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

There is currently no usage information available for this product. We apologize for any inconvenience.

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History

There is currently no drug history available for this drug.

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Other Information

COMFORTIS (spinosad) is available in four sizes of chewable flavored tablets for oral administration to cats and kittens according to their weight. Each chewable flavored tablet is formulated to provide a minimum spinosad dosage of 22.5 mg/lb (50 mg/kg). Spinosad is a member of the spinosyns class of insecticides, which are non-antibacterial tetracyclic macrolides. Spinosad contains two major factors, spinosyn A and spinosyn D, derived from the naturally occurring bacterium, Saccharopolyspora spinosa. Spinosyn A and spinosyn D have the chemical compositions 2-[(6-deoxy-2,3,4 tri-O-methyl-α-L-mannopyranosyl)oxy]-13- [[5 (dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]- 9 ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16btetradecahydro- 14-methyl-1H-as-indaceno[3,2-d] oxacyclododecin-7,15-dione and 2-[(6-deoxy-2,3,4-tri-Omethyl- α-L-mannopyranosyl)oxy] 13-[[5-(dimethylamino) tetrahydro-6-methyl-2H-pyran-2 yl]oxy]-9-ethyl-2,3,3a,5a,5b, 6,9,10,11,12,13,14,16a,16b tetradecahydro-4,14-dimethyl- 1H-as-indaceno[3,2 d]oxacyclododecin-7,15-dione, respectively.

COMFORTIS (spinosad) is available in six sizes of chewable flavored tablets for oral administration to dogs and puppies according to their weight. Each chewable tablet is formulated to provide a minimum spinosad dosage of 13.5 mg/lb (30 mg/kg). Spinosad is a member of the spinosyns class of insecticides, which are non-antibacterial tetracyclic macrolides. Spinosad contains two major factors, spinosyn A and spinosyn D, derived from the naturally occurring bacterium, Saccharopolyspora spinosa. Spinosyn A and spinosyn D have the chemical compositions 2-[(6-deoxy-2,3,4-tri-Omethyl- α-L mannopyranosyl)oxy]-13-[[5-dimethylamino)- tetrahydro-6 methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b, 6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl- 1H-as Indaceno[3,2-d]oxacyclododecin-7, 15-dione and 2-[(6-deoxy 2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]- 13-[[5 dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl] oxy]-9 ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a, 16b tetradecahydro-4,14-dimethyl-1H-as-Indaceno[3,2-d] oxacyclododecin-7,15-dione, respectively.

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A4145 Spinal 22g Whitacre Recall
Side Effects & Adverse Reactions
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A4145 Spinal 22g Whitacre Manufacturers

  • Smiths Medical Asd, Inc.
    A4145 Spinal 22g Whitacre | Elanco Animal Health Co
    No Recall

    A4145 Spinal 22g Whitacre | Elanco Animal Health Co

    A4145 Spinal 22g Whitacre | Elanco Animal Health Co

    COMFORTIS is given orally once a month, at the minimum dosage of 22.5 mg/lb (50 mg/kg).

    Do not use the dosing schedule below when administering COMFORTIS to dogs, as it can result in an overdosage.

    Dosage Schedule:

    *Cats over 24 lbs should be administered the appropriate combination of tablets.

    Body Weight Spinosad Per Tablet
    (mg) Tablets
    Administered 2 to 4 lbs 90 One 4.1 to 6 lbs 140 One 6.1 to 12 lbs 270 One 12.1 to 24* lbs 560 One

    Administer COMFORTIS with food for maximum effectiveness.

    COMFORTIS is a chewable tablet that can be consumed by cats when offered by the owner just prior to or after feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications. COMFORTIS should be administered at monthly intervals.

    If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS with food and resume a monthly dosing schedule.

    Treatment with COMFORTIS may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS should continue the entire year without interruption.

    To minimize the likelihood of flea reinfestations, it is important to treat all animals within a household with an approved flea protection product.

    COMFORTIS is given orally once a month, at the recommended minimum dosage of 13.5 mg/lb (30 mg/kg).

    Do not use the dosing schedule below when administering COMFORTIS to cats, as it can result in an underdosage.

    Dosage Schedule:

    * Dogs over 120 lbs should be administered the appropriate combination of tablets.

    Body Weight Spinosad Per Tablet
    (mg) Tablets
    Administered 3.3-4.9 lbs 90 One 5 to 10 lbs 140 One 10.1 to 20 lbs 270 One 20.1 to 40 lbs 560 One 40.1 to 60 lbs 810 One 60.1 to 120* lbs 1620 One

    Administer COMFORTIS with food for maximum effectiveness.

    COMFORTIS is a chewable tablet and is readily consumed by dogs when offered by the owner just prior to feeding. Alternatively, COMFORTIS may be offered in food or administered like other tablet medications. COMFORTIS should be administered at monthly intervals. If vomiting occurs within an hour of administration, redose with another full dose. If a dose is missed, administer COMFORTIS with food and resume a monthly dosing schedule.

    Treatment with COMFORTIS may begin at any time of the year, preferably starting one month before fleas become active and continuing monthly through the end of flea season. In areas where fleas are common year-round, monthly treatment with COMFORTIS should continue the entire year without interruption.

    To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea protection product.

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