Vitamin K1 10 mg/ml Solution for Injection

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Phytomenadione

Հասանելի է:

Bimeda Animal Health Limited

ATC կոդը:

QB02

INN (Միջազգային անվանումը):

Phytomenadione

Դոզան:

10 milligram(s)/millilitre

Դեղագործական ձեւ:

Solution for injection

Ռեկվիզորի տեսակը:

POM: Prescription Only Medicine as defined in relevant national legislation

Թերապեւտիկ տարածք:

ANTIHEMORRHAGICS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

1991-10-01

Ապրանքի հատկությունները

Health Products Regulatory Authority
10 June 2019
CRN008RM6
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitamin K1 10 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Active Substance
​
per ml
​
​
Phytomenadione
​
10.0
​mg
​
​
​
​
Excipients
​
​
​
Benzyl Alcohol (preservative)
​
9.0
​mg
​
Butylhydroxyanisole (antioxidant)
​
1.0
​mg
​
Butylhydroxytoluene (antioxidant)
​
1.0
​mg
​
​
​
​
For a full list of excipients, see section 6.1
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Domestic animals.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Vitamin K1 Injection is indicated in the treatment of
hypoprothrombinaemia associated with poisoning by warfarin or other
coumarins.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Acute haemorrhage may also require transfusion therapy. Phytomenadione
will not counteract the anticoagulant action of
heparin.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Intravenous injections should be administered slowly.
If separation has occurred or if oil droplets have appeared, the
product should not be used.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Anaphylactoid and other hypersensitivity reactions may occur following
intravenous administration. Fatalities have occurred
with products of this kind although it is unclear whether these
reactions were caused by phytomenadione itself or by
Health Products Regulatory Authority
10 June 2019
CRN008RM6
Page 2 of 3
surfactants included in the formulation. Pain and swelling may occur
at injection sites following administration of
phytomenadione.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Vitamin K1 does not ap