Camphor-Salicylicum ointment ointment

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

camphor, salicylic acid

Dostępny od:

Vetprom AD

Kod ATC:

QM02AC99

INN (International Nazwa):

camphor, salicylic acid

Dawkowanie:

7,5g/50g+ 3,75g/50g

Forma farmaceutyczna:

ointment

Sztuk w opakowaniu:

aluminium tube 50g

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2020-06-02

Ulotka dla pacjenta

1
LEAFLET FOR:
CAMPHOR – SALICYLIC ACID OINTMENT
CAMPHOR-SALICYLICUM OINTMENT
For cattle, horses, donkeys, sheep, goats, dogs and cats
1.
NAME AND ADDRESS OF THE AUTHORIZATION HOLDER AND OF THE PRODUCER (IF
THEY
DIFFERENT)
VETPROM AD, 2400, Radomir, Bulgaria, 26, Otets Paisij Str.
Tel.:[phone]
E-mail: [e-mail]
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
CAMPHOR – SALICYLIC ACID OINTMENT
CAMPHOR - SALICYLICUM OINTMENT
3. ACTIVE SUBSTANCE AND EXCIPIENTS
50 g of the ointment contain:
ACTIVE SUBSTANCE:
Camphor 7.5 g
Salicylic Acid 3.75 g
EXCIPIENTS:
Colloidal anhydrous silica, sunflower oil, wool fat, white soft
paraffin
4.
THERAPEUTIC INDICATIONS
Used in rheumatic and traumatic inflammations of the muscles and
joints; tendinitis, tendovaginitis and bursitis; injuries
class I and class II; periostitis, synovitis, neuritis, abscesses,
phlegmons and other diseases of the musculoskeletal system.
Mastitis (acute and chronic), mammary gland edema.
5.
CONTRAINDICATIONS
This drug product is contraindicated in animals with a history of
sensitivity to any of its components.
Not to be administered in the conjunctiva, because it causes local
irritation!
6. ADVERSE REACTIONS
2
Skin irritations are possible.
The frequency of the adverse reactions is defined using the following
classification:
- very common (more than 1 of 10 animals suffer from the ADR during
one treatment course);
- frequent (more than 1 but less than 10 animals out of 100 animals);
- infrequent (more than 1 but less than 10 animals out of 1 000
animals)
- rare (more than 1 but less than 10 animals out of 10 000 animals);
- very rare (less than 1 animal out of 10 000 animals, including
isolated reports).
If a serious impact or other effect, due to the use of this VMP not
listed in this leaflet is observed, please inform your
veterinarian immediately.
7.
ANIMAL SPECIES, FOR WHICH THIS VMP IS DESIGNED
Cattle, horses, donkeys, sheep, goats, dogs and cats
8.
RECOMMENDED DOSES FOR EACH OF THE ANIMAL SPECIES, ADMINISTRATION ROUTE
For external use

Charakterystyka produktu

SUMMARY PRODUCT CHARACTERISTIC CAMPHOR-SALICYLICUM OINTMENT
1. NAME OF THE VMP AND CONCENTRATION / ACTIVITY.
КАМФОР- САЛИЦИЛИКУМ маз
CAMPHOR-SALICYLICUM ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Camphor 7.5 g/50 g
Salicylic Acid 3.75 g/50 g
EXCIPIENTS:
For the full list of the excipients, see p. 6.1.
3. PHARMACEUTICAL FORM.
Ointment for skin application.
4. CLINICAL DATA.
4.1. ANIMALS FOR WHICH THE VMP IS INTENDED.
Cattle, horses, donkeys, pigs, sheep, goats, dogs and cats.
4.2. THERAPEUTIC INDICATIONS FOR INDIVIDUAL ANIMAL SPECIES
Rheumatic and traumatic inflammation of the muscles and joints;
tendinitis, tendovaginitis and
bursitis; Type I and II strokes; periodites, synovitis, neuritis,
abscesses, phlegmon and other
diseases of the locomotor system. Mastitis (acute and chronic), breast
oedema.
4.3. CONTRAINDICATIONS.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not apply conjunctively due to local irritation!
4.4. SPECIAL PRECAUTIONS FOR THE ANIMALS FOR WHICH IT IS INTENDED.
None.
4.5. SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6. ADVERSE REACTIONS (FREQUENCY AND IMPORTANCE)
Photosensitivity reactions and skin rashes may occur.
The frequency of adverse reactions is determined by the following
classification:
- very common (more than 1 in 10 animals exhibiting adverse reactions
during the course of one
treatment)
- common (more than 1 but less than 10 animals per 100 animals)
- uncommon (more than 1 but less than 10 animals per 1,000 animals)
- rare (more than 1 but less than 10 animals per 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated
messages).
4.7. USE DURING PREGNANCY, LACTATION OR LAYING.
It can be used during pregnancy and lactation.
4.8. INTERACTION WITH OTHER VETERINARY MEDICINAL PRODUCTS AND OTHER
FORMS OF