Cyclo Spray, Chlortetracycline HCI 2.45% w/w, Cutaneous Spray, Suspension for Pigs, Sheep and Cattle

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
12-09-2023

Viambatanisho vya kazi:

Chlortetracycline Hydrochloride

Inapatikana kutoka:

Eurovet Animal Health B.V.

ATC kanuni:

QD06AA02

INN (Jina la Kimataifa):

Chlortetracycline Hydrochloride

Dawa fomu:

Cutaneous spray, suspension

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cattle, Pigs, Sheep

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

2006-08-14

Tabia za bidhaa

                                Amended Pages: March 2023
AN:
03327/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclo Spray, Chlortetracycline HCl 2.45 % w/w, cutaneous spray,
suspension for
pigs, sheep and cattle.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Chlortetracycline HCl.
The active ingredient content is 2.45 % w/w
EXCIPIENTS:
Patent Blue V, colouring agent
0.15 % w/w
Butane 100
68.77 % w/w
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Spray, suspension
Blue colored
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
•
Prevention of infections of superficial traumatic or surgical wounds
caused by
micro-organisms sensitive to chlortetracycline.
•
The product can be used as part of a treatment for superficial
claw/hoof
infections, in particular interdigital dermatitis (foot rot) in sheep
and digital
dermatitis in cattle.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to tetracyclines.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Amended Pages: March 2023
AN:
03327/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Protect the eyes when spraying in the vicinity of the head. Clean the
affected
area thoroughly before spraying. Treatment of foot conditions should
always
be preceded by appropriate paring of the hoof, as this is critical for
achieving
an adequate response. After spraying the feet, the animal should be
kept on
dry ground for at least one hour.
The animal should be discouraged from licking the treated area, or
treated
areas on other animals.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Direct contact with the skin should be avoided because of
sensitisation,
contact dermatitis and possible hypersensitivity reactions to
chlortetracycline.
Wear appropriate impermeable gloves whilst handling the product.
Because of risk of eye irritation
                                
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