Intrafer-200 B12 solution for injection

מדינה: ארמניה

שפה: אנגלית

מקור: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

מרכיב פעיל:

iron, cyanocobalamin

זמין מ:

Interchemie werken "De Adelaar" Eesti AS

קוד ATC:

QB03AC90

INN (שם בינלאומי):

iron, cyanocobalamin

כמות:

200mg/ml+ 200mcg/ml

טופס פרצבטיות:

solution for injection

יחידות באריזה:

(1) glass bottle 100ml

סוג מרשם:

Prescription

מצב אישור:

Registered

תאריך אישור:

2019-12-30

עלון מידע

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:
Intrafer-200 B12.
PHARMACEUTICAL FORM:
Solution for parenteral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
iron (as dextran)
200.0 mg.
cyanocobalamin (vitamin B
12
)
200.0 μg.
- EXCIPIENTS:
phenol
5.0 mg.
INDICATIONS:
Iron dextran is used for prophylaxis and treatment of by iron
deficiency caused anaemia in piglets and
calves. Parental administration of iron has the advantage that the
necessary amount of iron can be
administered in one single dosage. Cyanocobalamin is used for
prophylactics and treatment of by
cyanocobalamin deficiency caused anaemia.
Intrafer-200 B12 solution for parenteral administration is indicated
for prophylactics and treatment of
anaemia in calves and piglets.
CONTRA-INDICATIONS:
Administration to animals with vitamin E-deficiency.
Administration to animals with diarrhoea.
Administration in combination with tetracyclines, because of the
interaction of iron with these drugs.
TARGET SPECIES:
Calves and piglets.
ADVERSE REACTIONS:
Muscle tissue is coloured temporarily by this preparation.
Leaking of injection fluid can cause a persistent discoloration of
skin.
DOSAGE AND ADMINISTRATION:
For intramuscular or subcutaneous administration.
Calves
: 2 - 4 ml, subcutaneously, in the first week after birth.
Piglets
: 1 ml, intramuscularly, 3 days after birth.
WITHDRAWAL TIMES:
None.
PACKAGING:
Brown (amber) type II glass bottles of 100 ml closed with type I
butylsepta and sealed with aluminium caps.
SHELF LIFE AND STORAGE INSTRUCTIONS:
Intrafer-200 B12 has a 3-year shelf life when stored dark at room
temperature (15 – 25 °C). After o

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME:
INTRAFER-200 B12
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
ACTIVE INGREDIENTS
CONTENT
SPECIFICATION
Iron
(as iron dextran)
200.0 mg/ml
Manufacturer’s specifications
Cyanocobalamin
0.2 mg/ml
Ph. Eur.
OTHER INGREDIENTS
CONTENT
SPECIFICATION
Anhydrous sodium carbonate
88.0 mg/ml
Ph. Eur.
Sodium hydroxide
1.2 mg/ml
ad pH=5.8
Manufacturer’s specifications
Phenol
5.0 mg/ml
Manufacturer’s specifications
Water for injections
ad 1 ml
Ph. Eur.
3.
PHARMACEUTICAL FORM:
Aqueous solution for intramuscular or subcutaneous administration.
4.
PHARMACOLOGICAL PROPERTIES:
IRON DEXTRAN is used for prophylaxis and treatment of by iron
deficiency caused anaemia in
piglets and calves. Parental administration of iron has the advantage
that the necessary
amount of iron can be administered in one single dosage.
CYANOCOBALAMIN is used for prophylaxis and treatment of by
cyanocobalamin deficiency
caused anaemia.
5.
CLINICAL PARTICULARS:
5.0
Target species: Calves and piglets.
5.1
Indications.
Prophylaxis and treatment of anaemia in calves and piglets.
5.2
Contra-indications.
Administration to animals with vitamin E-deficiency.
Administration to animals with diarrhoea.
Administration in combination with tetracyclines, because of the
interaction of iron with
tetracyclines.
5.3
Undesirable effects.
Muscle tissue is coloured temporarily by this preparation.
Leaking of injection fluid can cause a persistent discoloration of
skin.
5.4
Special precautions for use.
Prevent spilling of injection fluid, because this can cause a
persistent discoloration of skin.
5.5
Use during pregnancy and lactation.
No restrictions.
5.6
Interactions.
Do
not
administer
together
with
tetracyclines
because
of
the
interaction
of
iron
and
tetracyclines and iron, resulting in no effectively from both
tetracycline and iron.
5.7
Dosage recommendations and method(s) of administration.
For intramuscular or subcutaneous administration.
Calves
: 2 - 4 ml subcutaneous, in the first week after birth.
Piglets
: 1 ml intramuscula