PENTAL VETERINARY INJECTION NON-STERILE

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

PENTOBARBITAL SODIUM

Tilgængelig fra:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

PENTOBARBITAL SODIUM 200 MG/ML

Indgivelsesvej:

INTRAPERITONEAL, INTRACARDIAC, I.V

Recept type:

Required

Fremstillet af:

CTS CHEMICAL INDUSTRIES LTD

Terapeutiske indikationer:

Euthanasia in dogs, cats, rodents, rabbits, cattle, sheep, goats, horses.

Autorisation dato:

2020-07-31

Indlægsseddel

רבוטקוא
2019
,ה/אפור
,ה/דבכנ ת/חקור
:ןודנה
ןוכדע ןולע
ל
אפור לש
ירנירטו תוקירז לטנפ
ולעה יכ םכעידוהל םישקבמ ונא
ן
ל
אפור
כדוע ןודנבש רישכתה לש
ן
.
ןולעה ןוכדע
ללוכ
,היוותה ןוכדע
ןתמ תרוצ
ו
.תורמחה
:תרשואמה היוותהה
rabbits, cattle, sheep, goats, horses.
Euthanasia in dogs, cats, rodents,
קזוחו בכרה
ליעפ רמוח
:
PENTOBARBITAL SODIUM 200 MG/ML
ועצוב וב עדימה אבומ ןלהלש טוריפב
דבלב םייתוהמ םייוניש
.
יוניש לעב טסקט וא טסקט תפסות
יתועמשמ
מוסמ
ן
.הצוח וקב תנמוסמ טסקט תקיחמ .עבצב םינוכדעה םיירקיעה
ל ןולעב
ר
אפו
םיאבה םיקרפב םניה
:
3.
PHARMACEUTICAL FORM:
IV, INTRAPERITONEAL, INTRACARDIAC, Solution for injection.
Clear, colorless solution, free from particulate matter, faintly
alcoholic odor.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, rodents, rabbits, cattle, sheep, goats, horses and mink
*
*
4.5 SPECIAL PRECAUTIONS FOR USE
*
*
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT
TO ANIMALS
*
*
Systemic uptake (including absorption via skin or eye) of
pentobarbital causes sedation, sleep, CNS
and respiratory depression. Moreover, this product may be irritating
to the eye and can cause irritation
to the skin as well as hypersensitivity reactions (due to the presence
of pentobarbital). Embryotoxic
effects cannot be excluded.
Avoid direct contact with the skin and eyes, including hand-to-eye
contact.
2
Avoid accidental self-injection or accidental injection of other
persons when administering the product.
*
Handle the product with utmost care, especially pregnant and
breastfeeding women.
*
*
Information for the health professional in case of exposure:
Emergency measures should be directed toward maintenance of
respiration and cardiac function. In
severe i

Produktets egenskaber

1
1.
NAME OF THE MEDICINAL PRODUCT:
PENTAL veterinary injection - NON-Sterile
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Pentobarbital sodium 200 mg per ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM:
IV, INTRAPERITONEAL, INTRACARDIAC, Solution for injection.
NON-Sterile, clear, colorless solution, free from particulate matter,
faintly alcoholic odor.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, rodents, rabbits, cattle, sheep, goats, horses and mink
4.2 THERAPEUTIC INDICATIONS
Euthanasia
4.3 CONTRAINDICATIONS
Do not use for anesthesia
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
•
NON-Sterile Solution for euthanasia only.
•
Intravenous injection of pentobarbital has the ability to cause
induction excitement in
several species of animal and adequate sedation should be applied if
deemed
necessary by the veterinary surgeon. Measures should be taken to avoid
perivascular
administration (e.g. by using intravenous catheter).
•
The intraperitoneal route of administration may cause a prolonged
onset of action with
an increased risk of induction excitement. Intraperitoneal
administration must only be
used following appropriate sedation. Measures should be taken to avoid
administration into the spleen or organs/tissue with low capacity for
absorption. This
route of administration is only suitable for small animals_. _
•
Intra-cardiac injection must only be used if the animal is heavily
sedated,
unconscious, or anesthetized.
•
To reduce the risk of induction excitement, euthanasia should be
performed in a quiet
area.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
•
The intravenous route of administration should be the route of choice
and adequate sedation
should be applied if deemed necessary by the veterinary surgeon. For
horses and cattle
premedication is mandatory.
Where intravenous administration is impossible, and only following
deep sedation, the
product may be administered via the intra-cardiac route in all named
species. Alternatively,
for