Zoetis Cerenia Manual

Zoetis Ikke kategoriseret Cerenia

Læs nedenfor 📖 manual på dansk for Zoetis Cerenia (3 sider) i kategorien Ikke kategoriseret. Denne guide var nyttig for 9 personer og blev bedømt med 4.5 stjerner i gennemsnit af 2 brugere

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Tablets and Injectable Solution
Antiemetic
CERENIA Tablets
For oral use in dogs only
CERENIA Injectable
For subcutaneous or intravenous injection in dogs and cats
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Maropitant is a neurokinin (NK 1
) receptor antagonist that blocks the pharmacological action of substance P in the central
nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is C
32H40N2O
C6H8O7H2O and the molecular weight 678.81. The chemical name is (2 -butyl-2-methoxybenzyl) quinuclidin-S S N tert,3 )-2-benzhydryl- -(5-
3-amine citrate monohydrate. Each peach-colored oval tablet is scored and contains 16, 24, 60or 160mg of maropitant as maropitant
citrate per tablet. Each mL of CERENIA Injectable Solution contains 10 mg maropitant, 63 mg sulphobutylether-beta-cyclodextrin, 3.3 mg
meta-cresol and water for injection.
The chemical structure of maropitant citrate is:
INDICATIONS: CERENIA (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to
motion sickness in dogs. CERENIA (maropitant citrate) Injectable Solution is indicated for the prevention and treatment of acute vomiting in
dogs and for the treatment of vomiting in cats.
DOSAGE AND ADMINISTRATION (CERENIA Tablets):
For Prevention of Acute Vomiting:
For Prevention of Acute Vomiting in dogs 2-7 months of age: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg
(0.9 mg/lb) body weight once daily for up to 5 consecutive days (see WARNINGS and Animal Safety).
For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg
(0.9 mg/lb) body weight once daily until resolution of acute vomiting.
If vomiting persists despite treatment, the case should be re-evaluated. CERENIA is most effective in preventing acute vomiting associated
with chemotherapy if administered prior to the chemotherapeutic agent.
For prevention of acute vomiting, dispense whole or half tablets in strength(s) that most closely result in a 2 mg/kg dose:
Dog body weight Number of Tablets
Pounds Kilograms 16 mg 24 mg 60 mg
8 4 1/2 
15 8 1
25 12  1
50 24  2
65 30  1
130 60   2
Interchangeable use with CERENIA Injectable Solution for Prevention of Acute Vomiting:
In dogs that are actively vomiting, to ensure that the full initial dose is administered, CERENIA Injectable Solution is recommended at a
dose of 1 mg/kg once daily. Thereafter, for the prevention of acute vomiting, may be CERENIA Tablets at a dose of 2 mg/kg once daily
used interchangeably with CERENIA Injectable Solution for up to 5 days.
For Prevention of Vomiting Due to Motion Sickness in dogs 4 months and older:
Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days
(see WARNINGS and Animal Safety).
Administer CERENIA Tablets a minimum of two hours prior to travel with a small amount of food to mitigate vomiting associated with
administration of the dose on an empty stomach; however, refrain from feeding a full meal prior to travel.
Prevention of Vomiting Due to Motion Sickness in Dogs 4 months of age and older:
Dispense whole or half tablets in strengths that most closely result in an 8 mg/kg dose once daily for up to 2 consecutive days:
Dog body weight Number of Tablets
Pounds Kilograms 16 mg 24 mg 60 mg 160 mg
2 1 1/2   
3 1.5 1/2 
4 2 1   
6 3  1 
8 4 2   
13 6  2 
16 7.5 1 
22 10  1/2
33 15   2 
44 20   1
66 30 1 1/2
88 40   2
132 60   3
CERENIA Injectable Solution should not be used interchangeably with CERENIA Tablets for the prevention of vomiting due to motion
sickness (8mg/kg).
DOSAGE AND ADMINISTRATION (CERENIA Injectable):
Use of refrigerated product may reduce the pain response associated with subcutaneous injection.
Dogs:
For Prevention and Treatment of Acute Vomiting in Dogs:
Dogs 2-4 Months of Age: Administer CERENIA Injectable Solution subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb)
of body weight once daily for up to 5 consecutive days.
Dogs 4 months of Age and Older: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg
(0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days.
In dogs that are actively vomiting, it is recommended to initiate treatment with CERENIA Injectable Solution. Thereafter, CERENIA Tablets may
be used for the prevention of acute vomiting at 2 mg/kg once daily. (See CERENIA Tablets package insert for complete prescribing information).
For Prevention of Vomiting in Dogs 4 months of Age and Older Caused by Emetogenic Medications or Chemotherapeutic Agents:
Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) of body weight one time,
45-60 minutes prior to use of emetogenic medications or chemotherapeutic agents.
Cats:
For Treatment of Vomiting in Cats 4 Months of Age and Older:
Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg
(0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days.
The underlying cause of acute vomiting should be identified and addressed in dogs and cats that receive CERENIA Injectable Solution.
If vomiting persists despite treatment, the case should be re-evaluated.
WARNINGS: Not for use in humans. Keep out of the reach of children. In case of accidental ingestion, injection, or exposure, seek medical
advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin
sensitization. Wash hands with soap and water after administering drug and in case of accidental skin exposure. CERENIA is also an ocular
irritant. In case of accidental eye exposure, flush with water for 15minutes and seek medical attention.
In puppies younger than 11weeks of age, histological evidence of bone marrow hypocellularity was observed at higher frequency and greater
severity in puppies treated with CERENIA compared to control puppies. In puppies 16weeks and older, bone marrow hypocellularity was not
observed (see ).ANIMAL SAFETY
PRECAUTIONS: The safe use of CERENIA Tablets and Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant
or lactating bitches or queens.
The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.
Use with caution in patients with hepatic dysfunction because CERENIA Injectable Solution is metabolized by CYP3A, CYP2D15 (dogs) and
CYP1A (cats) enzymes (see ). The influence of concomitant drugs that may inhibit the metabolism of CERENIA Injectable Pharmacokinetics
Solution has not been evaluated. CERENIA Injectable Solution is highly protein bound. Use with caution with other medications that are highly
protein bound. The concomitant use of CERENIA Injectable Solution with other protein bound drugs has not been studied in dogs or cats.
Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. Drug compatibility should be
monitored in patients requiring adjunctive therapy.
CERENIA Tablets causes dose related decreases in appetite and body weight (see ). To maximize therapeutic potential of ANIMAL SAFETY
CERENIA Tablets, the underlying cause of vomiting should be identified and addressed in dogs receiving CERENIA Tablets.
ADVERSE REACTIONS:
CERENIA Tablets
Prevention of Acute Vomiting (minimum of 2mg/kg)
The following adverse reactions were reported during the course of a US field study for the prevention of acute vomiting in dogs treated with
CERENIA Tablets at a minimum of 2mg/kg orally and/or Injectable Solution at 1 mg/kg subcutaneously once daily for up to 5consecutive days:
Frequency of Adverse Reactions by Treatment
Adverse Reaction Placebo (n=69) CERENIA (n=206)
# dogs % occurrence # dogs % occurrence
Death during study 4 5.8 10 4.9
Euthanized during study 0 0 2 1
Diarrhea 6 8.7 8 3.9
Hematochezia/bloody stool 5 7.2 4 1.9
Anorexia 2 2.9 3 1.5
Otitis/Otorrhea 0 0 3 1.5
Endotoxic Shock 1 1.4 2 1
Hematuria 0 0 2 1
Excoriation 0 0 2 1
Other clinical signs were reported but were <0.5% of dogs.
Prevention of Vomiting Due to Motion Sickness (minimum of 8mg/kg)
The following adverse reactions were reported during US studies for the prevention of vomiting due to motion sickness in dogs treated with
CERENIA Tablets at a minimum of 8mg/kg orally one time. Dogs may have experienced more than one of the observed adverse reactions.
Frequency of Adverse Reactions by Treatment
Adverse Reaction
Placebo (n=195) CERENIA (n=208)
# dogs % occurrence # dogs % occurrence
Hypersalivation 19 9.7 26 12.5
Vomiting10 0 11 5.3
Muscle Tremors 1 0.5 2 1
Sedation/Depression 3 1.5 2 1
Retching 3 1.5 1 0.5
Flatulence 0 0 1 0.5
1Not associated with motion sickness
The following adverse reactions were reported during a European field study for the prevention of vomiting due to motion sickness in dogs
treated with CERENIA Tablets at a minimum of 8mg/kg orally once daily for 2consecutive days. Dogs may have experienced more than one
of the observed adverse reactions.
Frequency of Adverse Reactions by Treatment
Adverse Reaction Placebo (n=106) CERENIA (n=107)
# dogs % occurrence # dogs % occurrence
Vomiting 4 4 10 9
Drowsiness/Lethargy/Apathy 1 1 8 8
Hypersalivation 2 2 5 5
Anxiety 0 0 2 2
Trembling/Tremors 0 0 2 2
Inappetence 0 0 2 2
Mucus in stool 0 0 1 1
The following Adverse Reactions were reported during the conduct of a US clinical field trial where CERENIA Tablets were administered once
daily for 28 consecutive days to 32 dogs: lethargy, vomiting, inappetence, corneal edema, and enlarged lymph nodes.
Post-Approval Experience (Revised May 2019)
The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM.
It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.
The following adverse events reported for dogs are listed in decreasing order of frequency: anorexia, depression/lethargy, hypersalivation,
vomiting, diarrhea, trembling, ataxia, allergic reactions, weight loss, convulsion, hyperactivity, and panting.
Cases of ineffectiveness have been reported.
Cases of death (including euthanasia) have been reported.
To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or
www.zoetis.com.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at
www.fda.gov/reportanimalae.
ADVERSE REACTIONS:
CERENIA Injectable
DOGS:
In a US field study for the prevention and treatment of vomiting associated with administration of cisplatin for cancer chemotherapy, the following
adverse reactions were reported in 77 dogs treated with CERENIA Injectable Solution at 1 mg/kg subcutaneously or 41 dogs treated with placebo:
Frequency of Adverse Reactions by Treatment
Adverse Reaction Placebo (n=41) CERENIA (n=77)
# dogs % occur # dogs % occur
Diarrhea 1 2.4 6 7.8
Anorexia 0 0 4 5.2
Injection site reaction
(swelling, pain upon injection) 0 0 3 4
Lethargy 1 2.4 2 2.6
The following adverse reactions were reported during the course of a US field study for the prevention and treatment of acute vomiting in dogs
treated with 1 mg/kg CERENIA Injectable Solution subcutaneously and/or CERENIA Tablets at a minimum of 2 mg/kg orally once daily for up to
5 consecutive days:

Produkt Specifikationer

Mærke: Zoetis
Kategori: Ikke kategoriseret
Model: Cerenia

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