Robenz 66G
1. NAME
Robenz@ 66 G,
robenidine (66 mg/g)
premix for medicated feed.
Broilers and turkeys
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1g premix for medicated feed includes:
Active substance:
robenidine hydrochloride 66 mg/g
Excipients:
Calcium lignosulfonate, calcium sulfate, dihydrate
3. PHARMACEUTICAL FORM
Premix for medicated feed.
4. PHARMACOLOGICAL DATA
Pharmacotherapeutic group: antiprotozoal funds; other antiprotozoal funds. ATCvet kod: QP51AX13
4.1. Pharmacodynamic data
Robenz @ 66G antiprotozoal is used for anticoccidial treatment in broiler production. Shows anticoccidial activities against: Eimeria acervulína, E. maxima, E. tenella, E. necatrix, E. brunetti i E. Mivati.
Acting robenidine hydrochloride is the result of dual action which is shown at different stages of the parasite's development in the intestinal mucosal part of broiler chickens. The first mechanism of action is reflected like this: robenidine hydrochloride inhibits the development of the first generation schizont, and the other is reflected by killing another generation schizont and possibly merozoite.
Also, robenidine hydrochloride acts on gametogenesis parasites. Dual mechanism of action is particularly advantageous for anticoccidial drugs, because the risk of relapse is reduced in case of bird's stress and following feed termination. Combination of coccidiocides and coccidiostatic effects is also important factor in minimizing the possibility of clinical manifestation of coccidiosis after the expiration of using robenidin hydrochloride.
By using histochemical techniques, it has been confirmed that robenidine hydrochloride has a negative effect on the development of the first generation of schizont, first generation of merozoite and the second generation of schizont. It was also confirmed that robenidine hydrochloride gives effect in preventing anticoccidial protein synthesis.
4.2. Pharmacokineticc data
Reabsorption
After orally application robenidine partially absorbes from the gastrointestinal tract (20 to 40%) and rapidly excretes, mainly is not metabolizing.
Distribution
After a single dose (5 to 8 times higher than the recommended dose) comes very fast robenidine distribution in tissues and the medicine reaches the highest concentration for 8 hours in the muscles, liver, kidneys and blood, fat (as in subcutaneous) and bile during 24 hours after application.
Metabolism
Biotransformation of robenidine is mostly made in the liver. Emerging metabolites are not active.
Elimination
Unresorbed robenidine is excreted in faeces and emerging metabolites.
4.3. Influences on the environment data
Robenidine hydrochloride is toxic to water organisms.
5. CLINICAL DATA
5.1. Target species
Broilers and turkeys
5.2. Indications
Robenz 66G is effective in the prevention of coccidiosis in:
- broilers: Eimeria acervulína, E. maxima, E. tenella, E. necatrix, E. brunetti and E. mivati.
- turkeys: Eimeria adenoides, E. maxima, E. tenella, E. necatrix, E. brunetti and E. mivati.
5.3. Contraindications
No
5.4. ADVERSE EFFECTS
If the medicine is applied in accordance with the instructions, side effects were not recorded. Drug is well tolerated and has a high therapeutic index.
5.5. Special warnings and precautions for using of the drug
Robenidine hydrohloride is toxic to water organisms.Don't use for hens.
5.6. Using during pregnancy and lactation
Not applicable
5.7. Interactions
Robenidine could not be used concurrently with other anticoccidial drugs.
5.8. Dosage and method of using
Robenz® 66G is applied orally, after sharing mixing with feed
| Kind | Robenidine hydrohloride | Robenz@ 66G in feed |
|---|---|---|
| Broilers | 30 - 36 ppm | 0,45 - 0, 55 kg/t |
| Turkeys | 30 - 36 ppm | 0,45 - 0, 55 kg/t |
5.9. Overdose
For broilers ten times higher doses don't lead to adverse effects (330 ppm). For turkeys several times higher doses do not lead to adverse effects (750 ppm).. Local effects: possible weak eye and skin irritation.
5.10. Special warnings for each target species
Do not apply for hens..
5.11. Withdrawal
Stop to give 5 days before slaughter.
5.12. Special warnings for people who give animals medicine:
When mixing medicine with food to avoid direct contact with skin or mucous membranes, and should wear gloves and masks, as well as appropriate protective clothing. If the medicine gets into your eyes, flush plenty of water. During the using do not drink or smoke and eat. Wash hands after use. If you have any allergic reaction, seek medical attention immediately.
6. PHARMACEUTICAL DATA
6.1. Incompatibility
No
6.2. Shelf life :
Shelf life: 3 years
Shelf life after opening - use immediately
Shelf life after living in the mixing of food 3 months.
6.3. SPECIAL WARNINGS FOR CARE MEDICINE
Store in a cool dry place below 25 ° C, protected from light. Keep out of the reach of children..
6.4. The type and contents of packaging
Packaging: Multilayer paper bags of 20 kg
6.5. SPECIAL MEASURES FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR REST OF MEDICINE
Unused drug or drugs the rest are destroyed in accordance with applicable regulations.