Macrolan-200 200mg/ml solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tylosin (tylosin tartrate)

Available from:

Interchemie werken De Adelaar B.V.

ATC code:

QJ01FA90

INN (International Name):

tylosin (tylosin tartrate)

Dosage:

200mg/ml

Pharmaceutical form:

solution for injection

Units in package:

glass bottle 100ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-02-06

Patient Information leaflet

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Marketing authorisation holder:
Manufacturer and batch releaser:
Interchemie werken “De Adelaar” B.V.
Interchemie werken “De Adelaar” Eesti AS
Metaalweg 8
Vanapere tee 14
5804 CG Venray
Viimsi, Harju county
The Netherlands
Estonia
NAME PRODUCT:
Macrolan-200.
PHARMACEUTICAL FORM:
Solution for parenteral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
tylosin (as tartrate)
200.0 mg.
- EXCIPIENTS:
benzyl alcohol
10.5 mg.
INDICATIONS:
Tylosin is a macrolide antibiotic with bacteriostatic action against
Gram-positive and Gram-negative bacteria like
Campylobacter, Mycoplasma, Pasteurella, Staphylococcus, Streptococcus
and Treponema spp.
Macrolan-200 solution for parenteral use is indicated for
gastrointestinal and respiratory infections caused by
tylosin sensitive micro-organisms like Campylobacter, Mycoplasma,
Pasteurella, Staphylococcus, Streptococcus
and Treponema spp. in calves, cattle, goats, sheep and swine.
CONTRA-INDICATIONS:
Hypersensitivity to tylosin.
Concurrent administration of penicillins, cephalosporins, quinolones
and cycloserine.
TARGET SPECIES:
Calves, cattle, goats, sheep and swine.
ADVERSE REACTIONS:
After intramuscular administration local reactions can occur, which
disappear in a few days.
Diarrhoea, epigastric pain and skin sensitisation can occur.
DOSAGE AND ADMINISTRATION:
For intramuscular administration
General
: 1 ml per 10 - 20 kg body weight for 3 - 5 days.
WITHDRAWAL TIMES:
- For meat
: 10 days.
- For milk
: 3 days.
PACKAGING:
Brown (amber) type II glass bottles of 100 ml closed with type I
butylsepta and sealed with aluminium caps.
SHELF LIFE AND STORAGE INSTRUCTIONS:
Macrolan-200 has a 3-year shelf life when stored dark at room
temperature (15 – 25 ºC). After opening, store
dark and refrigerated (2 – 8 °C), and finish within 2 weeks.
KEEP OUT OF REACH AND SIGHT O

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME MACROLAN-200
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
CONTENT
SPECIFICATION
Tylosin base
(as tartrate)
200.0 mg/ml
Manufacturer’s specifications
OTHER INGREDIENTS
CONTENT
SPECIFICATION
Benzyl alcohol
0.01 ml/ml
Ph. Eur.
Propylene Glycol
0.5 ml/ml
Ph. Eur.
Water for injections
ad 1 ml
Ph. Eur.
3.
PHARMACEUTICAL FORM
Solution for intramuscular administration.
4.
PHARMACOLOGICAL PROPERTIES
Tylosin is a macrolide antibiotic with a bacteriostatic action against
mainly Gram-positive
bacteria like Campylobacter, Mycoplasma, Pasteurella, Staphylococcus,
Streptococcus and
Treponema spp.
5.
CLINICAL PARTICULARS
5.0
Target species: Calves, cattle, goats, sheep and swine.
5.1
Indications.
Gastrointestinal and respiratory infections caused by tylosin
sensitive micro-organisms, like
Campylobacter, Mycoplasma, Pasteurella, Staphylococcus, Streptococcus
and Treponema
spp.
5.2
Contra-indications.
Hypersensitivity to tylosin.
Concurrent administration with penicillin’s, cephalosporines,
quinolones and cycloserine.
5.3
Undesirable effects.
After intramuscular administration local reactions can occur, which
disappear in a few days.
Diarrhoea, epigastric pain and skin sensitisation can occur.
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 MACROLAN-200 with other
preparations before injection.
5.7
Dosage recommendations and method(s) of administration.
For intramuscular administration.
General : 1.0 ml. per 10 - 20 kg. body weight for 3 - 5 days.
5.8
Overdose.
MACROLAN-200 has a broad safety margin.
5.9
Special warnings.
None.
5.10 Withdrawal times.
- For meat : 10 days.
- For milk : 3 days.
5.11 Special precautions to be taken by the person administering the
product.
Because of possible sensitisation and contact dermatitis direct skin
contact has to be
avoided during administration.
6.
PHARMACEUTICAL PARTICULA