Cepedex
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
16-11-2021
Valmisteyhteenveto
(SPC)
16-11-2021
Julkisesta arviointikertomuksesta
(PAR)
22-12-2016
Aktiivinen ainesosa:
Dexmedetomidine hydrochloride
Saatavilla:
CP-Pharma Handelsgesellschaft mbH
ATC-koodi:
QN05CM18
INN (Kansainvälinen yleisnimi):
dexmedetomidine
Terapeuttinen ryhmä:
Cats; Dogs
Terapeuttinen alue:
Psycholeptics, Hypnotics and sedatives
Käyttöaiheet:
Non-invasive, mildly to moderately painful, procedures and examinations which require restraint, sedation and analgesia in dogs and cats.Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures.Premedication in dogs and cats before induction and maintenance of general anaesthesia.
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-12-13
Pakkausseloste
29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET:
Cepedex 0.1 mg/mL solution for injection for dogs and cats
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
CP-Pharma Handelsgesellschaft mbH
Ostlandring 13
31303 Burgdorf
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cepedex 0.1 mg/mL solution for injection for dogs and cats
dexmedetomidine hydrochloride
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 mL contains:
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride
0.1 mg
(equivalent to dexmedetomidine
0.08 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
2.0 mg
Propyl parahydroxybenzoate
0.2 mg
Clear, colourless solution for injection.
4.
INDICATION(S)
Non-invasive, mildly to moderately painful procedures and examinations
which require restraint,
sedation and analgesia in dogs and cats.
Deep sedation and analgesia in dogs in concomitant use with
butorphanol for medical and minor
surgical procedures.
Premedication in dogs and cats before induction and maintenance of
general anaesthesia.
5.
CONTRAINDICATIONS
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that
are moribund.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
6.
ADVERSE REACTIONS
31
By virtue of its α2-adrenergic activity, dexmedetomidine causes a
decrease in heart rate and body
temperature.
A decrease in respiratory rate may occur in some dogs and cats.
Pulmonary oedema has been reported
rarely. Blood pressure will increase initially and then return to
normal or below normal. Due to
peripheral vasoconstriction and venous desaturation in the presence of
normal arterial oxygenation, the
mucous membranes may appear pale and/or with a blue tinge.
Vomiting may occur 5-10 minutes after injection. Some dogs and cats
may also vomit at the time of
recovery.
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cepedex 0.1 mg/mL solution for injection for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains:
ACTIVE SUBSTANCE:
Dexmedetomidine hydrochloride
0.1 mg
(equivalent to dexmedetomidine
0.08 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
2.0 mg
Propyl parahydroxybenzoate
0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Non-invasive, mildly to moderately painful procedures and examinations
which require restraint,
sedation and analgesia in dogs and cats.
Deep sedation and analgesia in dogs in concomitant use with
butorphanol for medical and minor
surgical procedures.
Premedication in dogs and cats before induction and maintenance of
general anaesthesia.
4.3
CONTRAINDICATIONS
Do not use in animals with cardiovascular disorders.
Do not use in animals with severe systemic disease or in animals that
are moribund.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The administration of dexmedetomidine to puppies younger than 16 weeks
and kittens younger than
12 weeks has not been studied.
4.5
SPECIAL PRECAUTIONS FOR USE
3
Special precautions for use in animals
Treated animals should be kept warm and at a constant temperature,
both during the procedure and
recovery.
It is recommended that animals are fasted for 12 hours prior to
Cepedex administration. Water may be
given.
After treatment, the animal should not be given water or food before
it is able to swallow.
Corneal opacities may occur during sedation. The eyes should be
protected by a suitable eye lubricant.
To be used with precaution in elderly animals.
The safety of dexmedetomidine has not been established in males
intended for breeding.
Nervous, aggressive or excited animals
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