Erythrocin 16.5 % w/w Soluble Powder for Oral Solution

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Prenos Lastnosti izdelka (SPC)
26-03-2019

Aktivna sestavina:

Erythromycin

Dostopno od:

Ceva Santé Animale

Koda artikla:

QJ01FA01

INN (mednarodno ime):

Erythromycin

Odmerek:

16.5 percent weight/weight

Farmacevtska oblika:

Powder for oral solution

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

erythromycin

Status dovoljenje:

Authorised

Datum dovoljenje:

1988-10-01

Lastnosti izdelka

                                Health Products Regulatory Authority
25 March 2019
CRN008YLP
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Erythrocin 16.5 % w/w Soluble Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each g of powder contains:
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​
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Active substance
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Erythromycin
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16.5 %
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w/w
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as erythromycin thiocyanate
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​
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Excipients
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Amaranth (E123)
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0.35 %
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w/w
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For a full list of excipients see section 6.1.
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3 PHARMACEUTICAL FORM
Powder for oral solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of chronic respiratory disease caused by Mycoplasma
infection where clinical experience, supported where
possible by sensitivity testing of the causal organism, indicates
Erythromycin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not possible,
therapy should be based on local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
The water system to which the product is added must be in good working
order and the header tanks and troughs must be
free of dust, algae or other particulate matter.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
Health Products Regulatory Authority
25 March 2019
CRN008YLP
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None known.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration via th
                                
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