Doxy-500 WS

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

doxycycline (doxycycline hyclate)

Available from:

Interchemie werken 'De Adelaar' B.V.

INN (International Name):

doxycycline (doxycycline hyclate)

Dosage:

500mg/g

Pharmaceutical form:

powder oral

Prescription type:

Prescription

Patient Information leaflet

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Interchemie werken “De Adelaar” B.V.
Metaalweg 8
5804 CG Venray
The Netherlands
NAME PRODUCT: Doxy-500 WS.
PHARMACEUTICAL FORM: A yellow powder for oral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each g contains:
- ACTIVE SUBSTANCES:
doxycycline hyclate
500 mg.
INDICATIONS:
Doxycycline belongs to the group of tetracyclines and acts
bacteriostatically against many Gram-positive and
Gram-negative
bacteria
like
Bordetella,
Campylobacter,
E.
coli,
Haemophilus,
Pasteurella,
Salmonella,
Staphylococcus and Streptococcus spp. Doxycycline is also active
against Chlamydia, Mycoplasma and Rickettsia
spp. The action of doxycycline is based on inhibition of bacterial
protein synthesis. Doxycycline has good affinity
towards the lungs and is therefore especially useful for treatment of
bacterial respiratory infections.
Doxy-500 WS is indicated for gastrointestinal and respiratory
infections caused by doxycycline sensitive micro-
organisms like Bordetella, Campylobacter, Chlamydia, E. coli,
Haemophilus, Mycoplasma, Pasteurella, Rickettsia,
Salmonella, Staphylococcus and Streptococcus spp. in calves, goats,
poultry, sheep and swine.
CONTRA-INDICATIONS:
Hypersensitivity to tetracyclines.
Administration to animals with a seriously impaired hepatic function.
Administration to animals with an active microbial digestion.
Concurrent administration of penicillins, cephalosporins, quinolones
and cycloserine.
TARGET SPECIES: Calves, goats, sheep, poultry and swine (pre-ruminant
calves, lambs and kids only).
ADVERSE REACTIONS:
Discoloration of teeth in young animals.
Hypersensitivity reactions may occur.
Overdoses can result in renal toxicosis.
PRECAUTIONS:
Absorption of doxycycline is diminished by milk, and the salts of
trivalent or divalent cation including calcium,
magnesium, aluminium and iron due to the formation of insoluble
complexes.
DOSAGE AND ADMI

Summary of Product characteristics

PART I A: SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
DOXY-500 WS.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
CONTENT
STANDARD
Doxycycline hyclate
500.0 mg/g
Ph. Eur.
_OTHER INGREDIENT _
_Content _
_Standard _
Lactose monohydrate
ad 1 g/g
Manufacturer’s specifications
3.
PHARMACEUTICAL FORM
Water soluble powder for oral administration.
4.
PHARMACOLOGICAL PROPERTIES
Doxycycline belongs to the group of tetracyclines and acts
bacteriostatic against many
Gram-positive
and
Gram-negative
bacteria
like
Bordetella,
Campylobacter,
E.
coli,
Haemophilus,
Pasteurella,
Salmonella,
Staphylococcus
and
Streptococcus
spp.
Doxycycline is also active against Chlamydia, Mycoplasma and
Rickettsia spp. The action of
doxycycline is based on inhibition of bacterial protein synthesis.
Doxycycline has a great affinity to the lungs and is therefore
especially useful for treatment of
bacterial respiratory infections.
5.
CLINICAL PARTICULARS
5.0
Target species: Calves, goats, poultry, sheep and swine.
5.1
Indications.
Gastrointestinal and respiratory infections caused by doxycycline
sensitive micro-organisms,
like Bordetella, Campylobacter, Chlamydia, E. coli, Haemophilus,
Mycoplasma, Pasteurella,
Rickettsia, Salmonella, Staphylococcus and Streptococcus spp.
5.2
Contra-indications.
Hypersensitivity to tetracyclines.
Administration to animals with a seriously impaired hepatic function.
Concurrent administration of penicillins, cephalosporins, quinolones
and cycloserine.
Administration to animals with an active microbial digestion.
5.3
Undesirable effects.
Discoloration of teeth in young animals.
Hypersensitivity reactions.
5.4
Special precautions for use.
None.
5.5
Use during pregnancy and lactation.
No restrictions.
5.6
Interactions.
No significant interactions are known in open literature.
It is, however, not advisable to mix DOXY-500 WS with other
preparations.
5.7
Dosage recommendations and method(s) of administration.
For oral administration.
Calves, goats and sheep
:
Twice daily 1 gram per 100 kg body weight for 3 -