ALAMYCIN L.A. VETERINARY

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

OXYTETRACYCLINE AS DIHYDRATE

Prieinama:

COMEX LTD

Vaisto forma:

SOLUTION FOR INJECTION

Sudėtis:

OXYTETRACYCLINE AS DIHYDRATE 200 MG/ML

Vartojimo būdas:

I.M

Recepto tipas:

Required

Pagaminta:

NORBROOK LABORATORIES LTD, IRELAND

Terapinės indikacijos:

Antibiotic, treatment of sensitive microorganisms in cattle, pigs and sheep.

Leidimo data:

2014-07-31

Pakuotės lapelis

VETERINARY MEDICINE USER LEAFLET
Veterinarian Prescription only medicine
For animal use only
1.
NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE:
_ALAMYCIN LA VETERINARY, SOLUTION FOR INJECTION, 200 MG/ML_
2.
ACTIVE INGREDIENT:
Each 1 ml of the medicine contains:
_Oxytetracycline (as Dihydrate) _
_200 mg _
The medicine also contains the excipient:
Sodium Formaldehyde Sulphoxylate 2 mg
For a full list of excipients, see section 13 “further
information”
.
3. INDICATIONS FOR USE:
Antibiotic treatment of sensitive microorganisms in cattle, pigs and
sheep.
THERAPEUTIC GROUP:
Antibiotic.
4.
CONTRAINDICATIONS:
Do not use in animals suffering from hepatic or renal damage.
Do not use in animals with known hypersensitivity to Oxytetracycline.
5.
ADVERSE REACTIONS:
Although well tolerated, occasionally a slight local reaction of a
transient nature has
been observed.
Hypersensitivity reactions, including anaphylaxis (sometimes fatal),
have been
reported very rarely.
Side effects can be reported to the Ministry of Health by clicking on
the link "Reporting
adverse events due to drug treatment" found on the home page of the
Ministry of
Health website (www.health.gov.il) which refers to the online form for
reporting
adverse events, or by entering the link:
https://sideeffects.health.gov.il/
6.
TARGET SPECIES:
Cattle, pigs and sheep
7. AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE:
The recommended dose rate is 20 mg/kg bodyweight (i.e., 1 ml per 10 kg
bodyweight) administered by deep intramuscular injection.
8.
HOW TO USE THE PRODUCT:
Maximum recommended dose at any one site:
Cattle:
20 ml
Pigs:
5.5 ml
Sheep:
5 ml
Piglets:
1 day
0.2 ml
7 days
0.3 ml
14 days
0.4 ml
21 days
0.5 ml
over 21 days
1.0 ml/10 kg
9.
WITHDRAWAL PERIOD:
CATTLE:
Meat and offal: 35 days
Milk: 8 days
PIGS:
Meat and offal: 20 days
SHEEP:
Meat and offal:20 days
Milk: 8 days
10.
WARNINGS:
•
Special precautions regarding the use of the medicine for the target
animal:
None.
•
Special safety precautions regarding the use of the medicine in
animals:
D

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alamycin L.A. Veterinary
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Oxytetracycline (as Dihydrate)
200 mg
Excipient
Sodium Formaldehyde Sulphoxylate 2 mg
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Antibiotic, treatment of sensitive microorganisms in cattle, pigs and
sheep.
4.3
CONTRAINDICATIONS
Do not use in animals suffering from hepatic or renal damage.
Do not use in animals with known hypersensitivity to Oxytetracycline.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not dilute Alamycin LA.
If concurrent treatment is administered, use a separate injection
site.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
In case of contact with eyes or skin, wash immediately with water as
irritation may occur.
Wash hands after use.
Take care to avoid accidental injection.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Although well tolerated, occasionally a slight local reaction of a
transient nature has been observed.
Hypersensitivity reactions, including anaphylaxis (sometimes fatal),
have been reported very rarely.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Any suspected adverse events
should be reported to the Ministry of Health according to the National
Regulation by using an online form:
https://sideeffects.health.gov.il
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The use of tetracycline during the period of tooth and bone
development, including late pregnancy may
lead to tooth discoloration. Alamycin LA can be safe