Xyla 20mg/ml solution for injection

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

xylazine (xylazine hydrochloride)

Saadav alates:

Interchemie werken De Adelaar Eesti AS

ATC kood:

QN05CM92

INN (Rahvusvaheline Nimetus):

xylazine (xylazine hydrochloride)

Annus:

20mg/ml

Ravimvorm:

solution for injection

Ühikuid pakis:

glass bottle 50ml

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2015-04-16

Infovoldik

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Marketing authorisation holder:
Manufacturer and batch releaser:
Interchemie werken “De Adelaar” B.V.
Interchemie werken “De Adelaar” Eesti AS
Metaalweg 8
Vanapere tee 14
5804 CG Venray
Viimsi, Harju county
The Netherlands
Estonia
NAME PRODUCT: Xyla.
PHARMACEUTICAL FORM: A clear and colourless solution for parenteral
use.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
xylazine (as hydrochloride)
20.0 mg.
- EXCIPIENTS:
benzyl alcohol
10.5 mg.
sodium metabisulphite
1.0 mg.
INDICATIONS:
Xylazine has sedative, analgesic and muscle-relaxing properties. Xyla
is indicated for all cases where sedation is
needed, _ e.g._ during transport, partus, hoof treatment, small
operations (_e.g._ de-horning), and as a pre-
anaesthetic for larger operations (caesarean section) in cats, cattle,
dogs, horses and sheep.
CONTRA-INDICATIONS:
Administration during gestation or to animals with pulmonary and/or
cardiac diseases.
Administration to animals with pyometra, because these animals are
often hypersensitive to this preparation.
TARGET SPECIES:
Cattle, horses, sheep, dogs and cats.
ADVERSE REACTIONS:
Decreased heart and respiratory rate, hypersalivation and/or vomiting
may occur. Do not use in pregnant
animals.
DOSAGE AND ADMINISTRATION:
Cattle
: for intramuscular administration.
- dose 1
: 0.25 ml per 100 kg body weight; sedation, small operations.
- dose 2
: 0.5 ml per 100 kg body weight; small operations. Animals usually
remain standing.
- dose 3
: 1.0 ml per 100 kg body weight; larger operations. Animals lie down.
- dose 4
: 1.5 ml per 100 kg body weight; very extensive operations. Animals
have to fast for a couple of hours before
administration.
Horses
: 4 ml per 100 kg body weight for intravenous administration, or 10 ml
per 100 kg body weight for intramuscular administration.
With larger operations: preferably in combinatio

Toote omadused

PART I A: SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
Xyla.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT
CONTENT
Xylazine base
(as HCl)
20.0 mg/ml
_OTHER INGREDIENTS _
_Content _
Sodium metabisulphite
1.0 mg/ml
Citric acid, anhydrous
10.0 mg/ml
Benzyl alcohol
0.01 ml/ml
Sodium hydroxide
ad pH = 5.0
Water for injections
ad 1 ml
3.
PHARMACEUTICAL FORM
A clear, colourless solution for parenteral administration.
4.
PHARMACOLOGICAL PROPERTIES
Xylazine has sedative, analgesic and muscle-relaxing properties.
5.
CLINICAL PARTICULARS
5.0
TARGET SPECIES:
Cats, cattle, dogs, horses and sheep.
5.1
INDICATIONS.
All cases where sedation is needed, _e.g_. during transport, partus,
hoof treatment,
small operations (e.g. de-horning), and as a pre-anaesthetic for
larger operations
(caesarean section).
5.2
CONTRA-INDICATIONS.
Administration during gestation or to animals with lung- and/or heart
diseases.
Administration
to
animals
with
pyometra,
because
these
animals
are
often
hypersensitive to this preparation.
5.3
UNDESIRABLE EFFECTS.
Decreased heart and respiratory rate.
Hypersalivation and vomiting.
May
rarely
cause
severe
hypersensitivity
reactions
and
bronchospasm
(conditioned by availability of sodium metabisulfite).
5.4
SPECIAL PRECAUTIONS FOR USE.
During application, keep the animals as quiet as possible.

-adrenergic antagonists yohimbine, idazoxan and tolazoline can be used
to
shorten the
sedative effect.
5.5
USE DURING PREGNANCY AND LACTATION
Do not use in pregnant animals.
5.6
INTERACTIONS
No significant interactions are known in open literature.
It is, however, not advisable to mix XYLA with other preparations
before injection.
5.7
DOSAGE RECOMMENDATIONS AND METHOD(S) OF ADMINISTRATION.
Cattle
: for intramuscular administration
- dose 1 : 0.25 ml. per 100 kg. body weight; sedation, small
operations.
- dose 2 : 0.5 ml. per 100 kg. body weight; small operations. Animals
usually
remain standing.
- dose 3 : 1.0 ml. per 100 kg. body weight; larger operations. Animals
lie down.
- dose 4 : 1.5 ml. per 100 k