ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Cerenia 16 mg tablets for dogs
Cerenia 24 mg tablets for dogs
Cerenia 60 mg tablets for dogs
Cerenia160 mg tablets for dogs
2.
Active substance:
Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate.
Excipients:
Each tablet contains 0.075% w/w Sunset Yellow (E110) as a colourant
For a full list of excipients, see section 6.1.
3.
Pale orange tablet
The tablets have a score line on both sides allowing the tablet to be halved. Each tablet is marked with
the Pfizer logo on the reverse side. On the obverse side, each half is marked with the letters “MPT”
and figures denoting the quantity of maropitant.
4.
Dogs.
•
For the prevention of nausea induced by chemotherapy.
•
For the prevention of vomiting including that induced by motion sickness.
•
For the treatment of vomiting, in conjunction with Cerenia Solution For Injection and in
combination with other supportive measures.
None.
Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal
obstructions; therefore, appropriate diagnostic evaluations should be employed.
Cerenia tablets have been shown to be effective in the treatment of emesis, however where the
frequency of vomiting is high, orally administered Cerenia may not be absorbed before the next
vomiting event occurs. It is therefore recommended to initiate the treatment of emesis with Cerenia
Solution for Injection.
Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary
and supportive measures, such as dietary control and fluid replacement therapy while addressing the
underlying causes of the vomiting.
2
4.5
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of
age and in pregnant or lactating bitches. Use only according to the benefit/risk assessment by the
responsible veterinarian.
Maropitant is metabolised in the liver and therefore should be used with caution in patients with
hepatic disease.
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac
diseases as maropitant has affinity to Ca- and K-ion channels. Increases of approximately 10% in the
QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally;
however, such an increase is unlikely to be of clinical significance.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Wash hands after use. In case of accidental ingestion seek medical advice immediately and show the
package leaflet or the label to the physician.
Incidents of pre-travel vomiting, usually within two hours post-dosing were commonly reported after
administration of the 8 mg/kg dose.
Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive
reproductive toxicity studies have not been conducted in any animal species.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to
Ca-channels.
Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.
For oral use.
For motion sickness a light meal or snack before dosing is recommended; prolonged fasting before
administration should be avoided. However, Cerenia tablets should not be administered wrapped or
encapsulated in food as this may delay dissolution of the tablet and consequently the onset of efficacy.
Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
3
For the Prevention of Nausea induced by Chemotherapy and Treatment and Prevention of
Vomiting (except Motion Sickness)
To treat or prevent vomiting, Cerenia tablets should be administered once daily, at a dose of 2 mg
maropitant per kg bodyweight, using the number of tablets given in the table below. Tablets are
breakable along the score line on the tablet.
To prevent vomiting, tablets should be given more than 1 hour in advance. The duration of the effect is
approximately 24 hours and, therefore, tablets can be given the night before administration of an agent
that may cause emesis (e.g. chemotherapy).
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily
for up to five days.
Dog body weight
(kg)
16 mg 24 mg 60 mg
3.0 – 4.0 * ½
4.1 – 8.0 1
8.1 – 12.0 1
12.1 – 24.0 2
24.1 – 30.0 1
30.1 – 60.0 2
* Correct dose for dogs of less than 3 kg cannot be accurately achieved.
For Prevention of Vomiting induced by Motion Sickness
To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at
a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Tablets are breakable along the score line on the tablet.
Tablets should be administered at least one hour before starting the journey. The anti-emetic effect
persists for at least 12 hours, which for convenience may allow administration the night before early
morning travel. Treatment may be repeated for a maximum of two consecutive days.
Prevention of motion sickness
Dog body weight
(kg)
Number of Tablets
16 mg
24 mg
60 mg
160 mg
1.0 - 1.5
½
1.6 – 2.0
1
2.1 – 3.0
1
3.1 – 4.0
2
4.1 – 6.0
2
6.1 – 7.5
1
7.6 – 10.0
½
10.1 – 15.0
2
15.1 – 20.0
1
20.1 – 30.0
1½
30.1 – 40.0
2
4
Prevention of Nausea induced by Chemotherapy
Treatment and prevention of vomiting (except motion sickness)
Number of Tablets
40.1 – 60.0
3
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily
repeated administration, lower doses than recommended might be sufficient in some individuals and
when repeating the dose.
Cerenia tablets were well tolerated when administered for 15 days at dosages up to 10 mg/kg
bodyweight per day.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have
been observed when the product has been administered at doses in excess of 20 mg/kg.
Not applicable.
5.
Pharmacotherapeutic group: Antiemetics and Antinauseants, ATCvet code: QA04AD90
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting
the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
5.1 Pharmacodynamic properties
Vomiting is a complex process coordinated centrally by the emetic centre. This centre consists of
several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus)
that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli
from the circulation and the cerebro-spinal fluid.
Maropitant is a neurokinin 1 (NK
1
) receptor antagonist, which acts by inhibiting the binding of
substance P, a neuropeptide of the tachykinin family. Substance P is found in significant
concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter
involved in vomiting. By inhibiting the binding of substance P within the emetic centre, maropitant is
effective against neural and humoral (central and peripheral) causes of vomiting. A variety of
in vitro
assays have demonstrated that maropitant binds selectively at the NK
1
receptor with dose-dependent
functional antagonism of substance P activity.
In vivo
studies in dogs demonstrated the anti-emetic
efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and
syrup of ipecac.
Maropitant is non-sedative and should not be used as a sedative in motion sickness.
Maropitant is effective against vomiting. Signs of nausea including excessive salivation and lethargy
might remain during treatment.
5.2 Pharmacokinetic particulars
The pharmacokinetic profile of maropitant when administered as a single oral dose of 2 mg/kg body
weight to dogs was characterised by a maximum concentration (C
max
) in plasma of approximately 81
ng/ml; this was achieved within 1.9 hours post-dosing (T
max
). Peak concentrations were followed by a
decline in systemic exposure with an apparent elimination half-life (t
0.5
) of 4.03 hours.
At a dose of 8 mg/kg, C
max
of 776 ng/ml was reached at 1.7 hours post-dosing. The elimination half-
life at 8 mg/kg was 5.47 hours.
The inter-individual variation in kinetics may be large, up to 70 CV% for AUC.
5
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration..
Estimates for the oral bioavailability of maropitant were 23.7% at 2 mg/kg and 37.0% at 8 mg/kg. The
volume of distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg
ranged from approximately 4.4 to 7.0 l/kg. Maropitant displays non-linear pharmacokinetics (AUC
increases more than proportionally with increasing dose) when administered orally within the 1 - 16
mg/kg dose range.
Following repeated oral administration for five consecutive days at a daily dose of 2 mg/kg,
accumulation was 151%. Following repeated oral administration for two consecutive days at a daily
dose of 8 mg/kg, accumulation was 218%. Maropitant undergoes cytochrome P450 (CYP) metabolism
in the liver. CYP2D15 and CYP3A12 were identified as the canine isoforms involved in the hepatic
biotransformation of maropitant.
Renal clearance is a minor route of elimination, with less than 1% of an 8 mg/kg oral dose appearing
in the urine as either maropitant or its major metabolite. Plasma protein binding of maropitant in dogs
is more than 99%.
6.
6.1
List of excipients
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Sunset Yellow (E110) as a colourant
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Shelf life of the product as packaged for sale: 3 years
Shelf life of half tablets: 2 days.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
An unused half tablet should be returned to the opened blister and kept within the cardboard outer.
6.5 Nature and composition of immediate packaging
Cardboard box containing one aluminium-aluminium blister pack, each containing four tablets per
pack.
Cerenia tablets are available in 16 mg, 24 mg, 60 mg and 160 mg strength.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
6
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
EU/2/06/062/001 (16 mg tablets)
EU/2/06/062/002 (24 mg tablets)
EU/2/06/062/003 (60 mg tablets)
EU/2/06/062/004 (160 mg tablets)
9.
29/09/2006
<<TBD: Date of Commission Decision>>
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this product is available on the website of the European Medicines Agency
7
1.
Cerenia 10 mg/ml solution for injection for dogs.
2.
Active substance:
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate.
Excipients:
The solution for injection contains 3.3 mg/ml metacresol (as preservative).
For a full list of excipients, see section 6.1.
3.
Solution for injection
A clear, colourless to light yellow solution.
4.
Dogs
•
For the treatment and prevention of nausea induced by chemotherapy.
•
For the prevention of vomiting except that induced by motion sickness.
•
For the treatment of vomiting, in combination with other supportive measures.
None
Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal
obstructions; therefore, appropriate diagnostic evaluations should be employed.
Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary
and supportive measures such as dietary control and fluid replacement therapy while addressing the
underlying causes of the vomiting.
Although Cerenia has been demonstrated to be effective in both the treatment and prevention of
emesis induced by chemotherapy, it was found more efficacious if used preventively. Therefore, it is
recommended to administer the antiemetic prior to administration of the chemotherapeutic agent.
The use of Cerenia solution for injection against vomiting due to motion sickness is not recommended.
8
The safety of the veterinary medicinal product has not been established in dogs less than 16 weeks of
age and in pregnant or lactating bitches. Use only according to the benefit/risk assessment by the
responsible veterinarian.
Maropitant is metabolised in the liver and therefore should be used with caution in patients with
hepatic disease.
Cerenia should be used with caution in animals suffering from or with predisposition for cardiac
diseases as maropitant has affinity to Ca- and K-ion channels. Increases of approximately 10% in the
QT interval of the ECG were observed in a study on healthy beagle dogs administered 8 mg/kg orally;
however, such an increase is unlikely to be of clinical significance.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals
Wash hands after use. In case of accidental self-injection seek medical advice immediately and show
the package leaflet or the label to the physician. In laboratory studies, maropitant has been shown to
be a potential eye irritant. In the case of accidental eye exposure, flush the eyes with plenty of water
and seek medical attention
Pain at injection site may occur. In very rare cases, anaphylactic type reactions (allergic oedema,
urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
Use only according to the benefit/risk assessment by the responsible veterinarian, because conclusive
reproductive toxicity studies have not been conducted in any animal species.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to
Ca-channels.
Maropitant is highly bound to plasma proteins and may compete with other highly bound medicines.
For subcutaneous use.
Cerenia solution for injection should be injected subcutaneously, once daily, at a dose of 1 mg/kg
bodyweight (1 ml/10 kg bodyweight).
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily
for up to five days
To prevent vomiting, Cerenia solution for injection should be administered more than 1 hour in
advance. The effect duration is approximately 24 h and therefore treatment can be given the night
before administration of an agent that may cause emesis e.g. chemotherapy.
9
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily
repeated administration, lower doses than recommended might be sufficient in some individuals and
when repeating the dose.
Cerenia solution for injection was well tolerated in dogs injected daily with up to 5 mg/kg (5 times the
use dose) for 15 consecutive days (3-times the recommended duration of administration).
Not applicable.
5.
Pharmacotherapeutic group: Antiemetic, ATCvet code: QA04AD90
Maropitant is a potent and selective neurokinin (NK-1) receptor antagonist, which acts by inhibiting
the binding of substance P, a neuropeptide of the tachykinin family, in the CNS.
5.1
Pharmacodynamic properties
Vomiting is a complex process coordinated centrally by the emetic centre. This centre consists of
several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus)
that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli
from the circulation and the cerebro-spinal fluid.
Maropitant is a neurokinin 1 (NK
1
) receptor antagonist, which acts by inhibiting the binding of
substance P, a neuropeptide of the tachykinin family. Substance P is found in significant
concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter
involved in vomiting. By inhibiting the binding of substance P within the emetic centre, maropitant is
effective against neural and humoral (central and peripheral) causes of vomiting. A variety of
in vitro
assays have demonstrated that maropitant binds selectively at the NK
1
receptor with dose-dependent
functional antagonism of substance P activity.
In vivo
studies in dogs demonstrated the anti-emetic
efficacy of maropitant against central and peripheral emetics including apomorphine, cisplatin and
syrup of ipecac.
Maropitant is effective against vomiting. Signs of nausea including excessive salivation and lethargy
might remain after treatment.
5.2
Pharmacokinetic particulars
The pharmacokinetic profile of maropitant when administered as a single subcutaneous dose of 1
mg/kg body weight to dogs was characterised by a maximum concentration (C
max
) in plasma of
approximately 92 ng/ml; this was achieved within 0.75 hours post-dosing (T
max
). Peak concentrations
were followed by a decline in systemic exposure with an apparent elimination half-life (t1/2) of 8.84
hours.
During clinical studies maropitant plasma levels conferred efficacy from 1 hour after administration.
The bioavailability of maropitant after subcutaneous administration in dogs was 90.7%. The volume of
distribution at steady-state (Vss) determined after intravenous administration at 1 - 2 mg/kg ranged
from approximately 4.4 to 7.0 L/kg. Maropitant displays linear kinetics when administered
subcutaneously within the 0.5 – 2 mg/kg dose range.
10
Following repeated subcutaneous administration of once-daily doses of 1 mg / kg bodyweight for five
consecutive days, accumulation was 146%. Maropitant undergoes cytochrome P450 (CYP)
metabolism in the liver. CYP2D15 and CYP3A12 were identified as the canine isoforms involved in
the hepatic biotransformation of maropitant.
Renal clearance is a minor route of elimination, with less than 1% of a 1 mg/kg subcutaneous dose
appearing in the urine as either maropitant or its major metabolite. Plasma protein binding of
maropitant in dogs is more than 99%.
6.
6.1 List of excipients
Sulphobutyl ether β-cyclodextrin (SBECD)
Water for injections
Metacresol (as preservative)
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products in the same syringe.
6.3 Shelf life
Shelf life of the product as packaged for sale: 2 years.
Once broached, use within 28 days.
6.4. Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
20 ml, amber molded glass type 1 vial, chlorobutyl rubber stopper and aluminium overseal with flip-
off button. Each cardboard outer contains 1 vial.
6.6
Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
EU/2/06/062/005
11
9.
29/09/2006
19/03/2010
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
Detailed information on this product is available on the website of the European Medicines Agency
(EMA)
http://www.ema.europa.eu/
.
12
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
BATCH RELEASE
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
WITH REGARD TO SAFE AND EFFECTIVE USE
D. STATEMENT OF THE MRLs
13
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
Pfizer Global Manufacturing (PGM)
Z. I. de Pocé
29 route des Industries
F-37530 Pocé sur Cisse
France
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
REGARDING SUPPLY OR USE
Veterinary medicinal product subject to prescription.
The holder of this marketing authorisation must inform the European Commission about the marketing
plans for the medicinal product authorised by this decision.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
REGARD TO SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
Not applicable
14
ANNEX III
LABELLING AND PACKAGE LEAFLET
15
A. LABELLING
16
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON / Tablets
1.
Cerenia 16 mg tablets for dogs
Maropitant
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 16 mg maropitant as maropitant citrate monohydrate.
The tablets also contain Sunset yellow (E110) as a colourant.
3.
Tablets
4.
PACKAGE SIZE
4 tablets
5.
Dogs
6.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
7.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
It is recommended to initiate treatment of emesis with Cerenia Solution for Injection.
17
8.
EXPIRY DATE
EXP {month/year}
9.
SPECIAL STORAGE CONDITIONS
Not applicable.
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription
12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
EU/2/06/062/001
15. MANUFACTURER’S BATCH NUMBER
Lot
18
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER / Tablets
1.
Cerenia 16 mg
Maropitant
2.
Pfizer (Logo)
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
19
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON / Tablets
1.
Cerenia 24 mg tablets for dogs
Maropitant
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 24 mg maropitant as maropitant citrate monohydrate.
The tablets also contain Sunset yellow (E110) as a colourant.
3.
Tablets
4.
PACKAGE SIZE
4 tablets
5.
Dogs
6.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
7.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
It is recommended to initiate treatment of emesis with Cerenia Solution for Injection.
20
8.
EXPIRY DATE
EXP {month/year}
9.
SPECIAL STORAGE CONDITIONS
Not applicable.
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription
12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
EU/2/06/062/002
15. MANUFACTURER’S BATCH NUMBER
Lot
21
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER / Tablets
1.
Cerenia 24 mg
Maropitant
2.
Pfizer (Logo)
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
22
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON / Tablets
1.
Cerenia 60 mg tablets for dogs
Maropitant
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 60 mg maropitant as maropitant citrate monohydrate.
The tablets also contain Sunset yellow (E110) as a colourant.
3.
Tablets
4.
PACKAGE SIZE
4 tablets
5.
Dogs
6.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
Read the package leaflet before use.
7.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
It is recommended to initiate treatment of emesis with Cerenia Solution for Injection.
23
8.
EXPIRY DATE
EXP {month/year}
9.
SPECIAL STORAGE CONDITIONS
Not applicable.
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription
12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
EU/2/06/062/003
15. MANUFACTURER’S BATCH NUMBER
Lot
24
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER / Tablets
1.
Cerenia 60 mg
Maropitant
2.
Pfizer (Logo)
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
25
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON / Tablets
1.
Cerenia 160 mg tablets for dogs
Maropitant
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each tablet contains 160 mg maropitant as maropitant citrate monohydrate.
The tablets also contain Sunset yellow (E110) as a colourant.
3.
Tablets
4.
PACKAGE SIZE
4 tablets
5.
Dogs
6.
METHOD AND ROUTE(S) OF ADMINISTRATION
Oral use.
8 mg/kg bodyweight for motion sickness.
7.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
26
8.
EXPIRY DATE
EXP {month/year}
9.
SPECIAL STORAGE CONDITIONS
Not applicable.
10. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
11. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only - to be supplied only on veterinary prescription
12. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
EU/2/06/062/004
15. MANUFACTURER’S BATCH NUMBER
Lot
27
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER / Tablets
1.
Cerenia 160 mg
Maropitant
2.
Pfizer (Logo)
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
28
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARDBOARD CARTON
/
Solution for injection
1.
Cerenia 10 mg/ml solution for injection for dogs
Maropitant
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
10 mg maropitant per ml as maropitant citrate monohydrate.
Metacresol as preservative.
3.
Solution for injection
4.
PACKAGE SIZE
20 ml
5.
Dogs
6.
METHOD AND ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
1 mg/kg bodyweight.
7.
SPECIAL WARNING(S), IF NECESSARY
In case of accidental self-injection seek medical advice immediately and show the package leaflet or
the label to the physician.
Read the package leaflet before use.
8.
EXPIRY DATE
EXP {month/year}
Once broached, use by:…………..
29
9.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
10. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
RESTRICTIONS REGARDING SUPPLY AND USE
For animal treatment only- to be supplied only on veterinary prescription.
11. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Keep out of the reach and sight of children.
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/06/062/005
14. MANUFACTURER’S BATCH NUMBER
Lot
30
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
GLASS VIAL / Solution For Injection
1.
Cerenia 10 mg / ml solution for injection for dogs
Maropitant
2.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
20 ml
3.
ROUTE(S) OF ADMINISTRATION
Subcutaneous use.
4.
BATCH NUMBER
Lot
5.
EXPIRY DATE
EXP {month/year}
Once broached, use within 28 days.
6.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET FOR:
Cerenia tablets for dogs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
Manufacturing Authorisation Holder Responsible for Batch Release
Pfizer PGM
37530 Pocé sur Cisse
France
2.
Cerenia 16 mg tablets for dogs
Cerenia 24 mg tablets for dogs
Cerenia 60 mg tablets for dogs
Cerenia 160 mg tablets for dogs
Maropitant
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Each tablet contains 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate.
The tablets also contain Sunset Yellow (E110) as a colourant
The tablets are pale orange and have a score line on both sides allowing the tablet to be halved. Each
tablet is marked with the Pfizer logo on the reverse side. On the obverse side, each half is marked with
the letters “MPT” and figures denoting the quantity of maropitant.
4.
•
For the prevention of nausea induced by chemotherapy.
•
For the prevention of vomiting including that induced by motion sickness.
•
For the treatment of vomiting, in conjunction with
Cerenia solution for injection
and in
combination with other supportive measures.
5.
None
33
6.
ADVERSE REACTIONS
Administering Cerenia on a completely empty stomach may cause your dog to vomit. Giving your
dog a light meal or snack before administering the tablet could help preventing this effect. Prolonged
fasting before administration should be avoided.
Cerenia is not a sedative and some motion sick dogs may show nausea-like signs during travel such as
salivation and lethargy. These signs are temporary and should resolve when the journey ends.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Dogs
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For oral use
For Prevention of Nausea induced by Chemotherapy and Treatment and Prevention of
Vomiting (except Motion Sickness)
To treat and/or prevent vomiting except motion sickness, Cerenia tablets should be administered once
daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table
below. Tablets are breakable along the score line on the tablet.
To prevent vomiting, tablets should be given more than 1 hour in advance. The duration of the effect is
approximately 24 hours and, therefore, tablets can be given the night before administration of an agent
that may cause emesis (e.g. chemotherapy).
Cerenia can be used to treat vomiting either as tablets or as solution for injection once daily for up to
five days.
Dog body weight
(kg)
Prevention of Nausea induced by Chemotherapy
Treatment and prevention of vomiting (except motion sickness)
Number of Tablets
16 mg 24 mg 60 mg
3.0 – 4.0 * ½
4.1 – 8.0 1
8.1 – 12.0 1
12.1 – 24.0 2
24.1 – 30.0 1
30.1 – 60.0 2
* Correct dose for dogs of less than 3 kg cannot be accurately achieved.
For Prevention of Vomiting induced by Motion Sickness
To prevent vomiting induced by motion sickness, Cerenia tablets should be administered once daily, at
a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below.
Tablets are breakable along the score line on the tablet.
34
Tablets should be administered at least one hour before starting the journey. The anti-emetic effect
persists for at least 12 hours, which for convenience may allow administration the night before early
morning travel. Treatment may be repeated for a maximum of two consecutive days.
In some individual dogs and when repeating the treatment, lower doses than recommended might be
sufficient.
Prevention of motion sickness only
Dog body weight
(kg)
Number of Tablets
16 mg
24 mg
60 mg
160 mg
1.0 - 1.5
½
1.6 – 2.0
1
2.1 – 3.0
1
3.1 – 4.0
2
4.1 – 6.0
2
6.1 – 7.5
1
7.6 – 10.0
½
10.1 – 15.0
2
15.1 – 20.0
1
20.1 – 30.0
1½
30.1 – 40.0
2
40.1 – 60.0
3
9.
ADVICE ON CORRECT ADMINISTRATION
To remove a tablet from the blister the following sequence should be carried out;
•
Firstly, fold or cut along the perforation between each tablet as shown by the scissor symbol
.
•
Find the pull-back notch (or cut) as shown by the arrow symbol
Æ
.
•
Holding one side of the cut firmly, pull the other side towards the centre of the blister until the
tablet is visible
•
Remove table from blister and administer as instructed.
Note
: No attempt should be made to remove the tablet by pushing it through the blister backing as this
will damage both the tablet and blister.
For motion sickness a light meal or snack before dosing is recommended, prolonged fasting before
administration should be avoided. Cerenia tablets should not be administered wrapped or encapsulated
in food as this may delay dissolution of the tablet and consequently the onset of the effect.
Dogs should be carefully observed following administration to ensure that each tablet is swallowed.
Not applicable.
35
11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Half tablets should be stored for a maximum of two days after removal from the blister. Half-tablets
should be returned to the opened blister and kept within the cardboard outer.
Do not use after the expiry date, which is mentioned on the blister after EXP.
12. SPECIAL WARNINGS
Vomiting can be associated with serious, severely debilitating conditions and the cause should be
investigated. Products such as Cerenia should be used in conjunction with other supportive measures
such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver
disease.
The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or
lactating bitches. The responsible veterinarian should make a benefit-risk assessment before using
Cerenia in dogs under 16 weeks of age or in pregnant or lactating bitches.
Clinical signs including vomiting on first administration, excess salivation and watery faeces have
been observed when the product has been overdosed in excess of 20 mg/kg.
Wash hands after use. In case of accidental ingestion seek medical advice immediately and show the
package leaflet or the label to the physician. .
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH PACKAGE LEAFLET WAS LAST APPROVED
<<TBD: Date of Commission Decision>>
15. OTHER INFORMATION
Cerenia tablets are supplied in blister packs with four tablets per pack. Not all pack sizes may be
marketed.
For any information about this veterinary medicinal product, please contact the local representative of
the Marketing Authorisation Holder.
36
België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tel./Tél.: +32 (0)2 554 62 11
Luxembourg/Luxemburg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
Република България
Pfizer H.C.P. Corporation
Tel: + 359 2 970 43 21
Magyarország
Pfizer KFT
Tel: +361 488 3695
Česká republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
Danmark
Orion Pharma
Animal Health
Tlf: +45 49 12 67 65
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH,
Tel: +49 30 550 055 01
Norge
Orion Pharma Animal Health
Tlf: +47 40 00 41 90
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria G.m.b.H,
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 2 10 678 5800
Polska
Pfizer Trading Polska sp. z.o.o.
Tel: +48 22 335 62 00
España
Pfizer S.A.
Teléfono: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda.
Telefone: +351 21 423 55 00
France
Pfizer
Téléphone: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Telephone: + 353 (0)1 467 6500
Slovenija
Pfizer Animal Health
Pfizer Luxembourg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Icepharma Ltd
Tel: +354 540 80 80
Slovenská republika
Pfizer Animal Health
Tel: +421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Telefono: +39 06 3318 2933
Suomi/Finland
Pfizer Oy Animal Health,
Telephone: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 2 10 678 5800
Sverige
Orion Pharma Animal Health
Tel: +46 (0)8 623 64 40
37
Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Telephone: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
38
PACKAGE LEAFLET FOR:
Cerenia 10 mg/ml solution for injection for dogs
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE IF DIFFERENT
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
Manufacturing Authorisation Holder Responsible For Batch Release
Pfizer PGM
37530 Pocé sur Cisse
France
2.
Cerenia 10 mg/ml solution for injection for Dogs
Maropitant
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
The solution for injection contains 10 mg maropitant per ml as maropitant citrate monohydrate as a
clear, colourless to light yellow solution
It also contains metacresol (as preservative).
4.
INDICATIONS
•
For the treatment and prevention of nausea induced by chemotherapy.
•
For the prevention of vomiting except that induced by motion sickness.
•
For the treatment of vomiting, in combination with other veterinary and supportive measures.
5.
None
6.
ADVERSE REACTIONS
Pain at injection site may occur. In very rare cases, anaphylactic type reactions (allergic oedema,
urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
39
7.
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
For subcutaneous use
Cerenia solution for injection should be injected subcutaneously, once daily, at a dose of 1 mg/kg
bodyweight (1 ml/10 kg bodyweight).
Treatment may be repeated for up to five consecutive days.
Cerenia can be used to treat or prevent vomiting either as tablets or as solution for injection once daily
for up to 5 days.
9.
ADVICE ON CORRECT ADMINISTRATION
To prevent vomiting, Cerenia solution for injection should be administered more than 1 hour in
advance. The effect duration is approximately 24 h and therefore treatment can be given the night
before administration of an agent that may cause emesis e.g. chemotherapy.
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
This veterinary medicinal product does not require any special storage conditions.
Once opened, the vial should be used within 28 days.
Do not use after the expiry date, which is mentioned on the label of the vial after EXP.
12. SPECIAL WARNINGS
Vomiting can be associated with serious, severely debilitating conditions and the cause should be
investigated. Products such as Cerenia should be used in conjunction with other supportive measures
such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver
disease.
The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or
lactating bitches. The responsible veterinarian should make a benefit-risk assessment before using
Cerenia in dogs under 16 weeks of age or in pregnant or lactating bitches.
Cerenia should be used with caution in animals suffering from or with predisposition for heart
diseases.
Wash hands after use. In case of accidental self injection seek medical advice immediately and show
the package leaflet or the label to the physician. In the case of accidental eye exposure, flush the eyes
with plenty of water and seek medical attention.
40
Cerenia must not be mixed with other veterinary medicinal products in the same syringe as its
compatibility with other products has not been tested.
Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to
Ca-channels.
Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.
14. DATE ON WHICH PACKAGE LEAFLET WAS LAST APPROVED
19/03/2010
15. OTHER INFORMATION
Cerenia 10 mg per ml solution for injection for dogs is available in 20 ml amber glass vials. Each
cardboard box contains 1 vial.
For any information about this veterinary medicinal product, please contact the local representative of
the Marketing Authorisation Holder.
België/Belgique/Belgien
Pfizer Animal Health s.a.,
Tel./Tél.: +32 (0)2 554 62 11
Luxembourg/Luxemburg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
Република България
Pfizer H.C.P. Corporation
Tel: + 359 2 970 43 21
Magyarország
Pfizer KFT
Tel: +361 488 3695
Česká republika
Pfizer Animal Health
Tel: +420 283 004 111
Malta
Agrimed Limited
Tel: +356 21 465 797
Danmark
Orion Pharma
Animal Health
Tlf: +45 49 12 67 65
Nederland
Pfizer Animal Health B.V.,
Tel: +31 (0)10 4064 600
Deutschland
Pfizer GmbH,
Tel: +49 30 550 055 01
Norge
Orion Pharma Animal Health
Tlf: +47 40 00 41 90
Eesti
Pfizer Animal Health
Tel: +370 5 269 17 96
Österreich
Pfizer Corporation Austria G.m.b.H,
Tel: +43 (0)1 52 11 57 20
41
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 2 10 678 5800
Polska
Pfizer Trading Polska sp. z.o.o.
Tel: +48 22 335 62 00
España
Pfizer S.A.
Teléfono: +34 91 4909900
Portugal
Laboratórios Pfizer, Lda.
Telefone: +351 21 423 55 00
France
Pfizer
Téléphone: +33 (0)1 58 07 46 00
Romania
Pfizer Romania SRL
Tel: + 0040 21 207 28 93
Ireland
Pfizer Healthcare Ireland, trading as:
Pfizer Animal Health
Telephone: + 353 (0)1 467 6500
Slovenija
Pfizer Animal Health
Pfizer Luxembourg SARL
Tel: +386 (0) 1 52 11 670
Ìsland
Icepharma Ltd
Tel: +354 540 80 80
Slovenská republika
Pfizer Animal Health
Tel: +421 2 3355 5500
Italia
Pfizer Italia S.r.l.,
Telefono: +39 06 3318 2933
Suomi/Finland
Pfizer Oy Animal Health,
Telephone: +358 (0)9 4300 40
Kύπρος
Pfizer Hellas A.E.
Τηλ.: +30 2 10 678 5800
Sverige
Orion Pharma Animal Health
Tel: +46 (0)8 623 64 40
Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Telephone: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
42
Source: European Medicines Agency
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