Selexol

AREA OF USE / INDICATIONS

In cattle

1. In cases of occult and undetectable oestrus in normal-cycling cattle: Cattle may be in normal cycle, but either do not show signs of estrus or show signs that are not easily noticed. Prior to Selexol injection, normal cycle activity in the ovaries should be determined by rectal palpation of the corpus luteum. Oestrus occurs 2-4 days after the application of Selexol, followed by artificial insemination or natural insemination at the time of estrus. If there is no estrus, another injection is given 11 days later. Seeding either 72-84. It can be done once between the hours of 72 and 96 hours or twice. 

2. For estrous cycle synchronization: To facilitate controlled production, there are different applications for estrous cycle synchronization:

- A single dose of Selexol injection is given to cattle determined to have corpus luteum by rectal palpation. Animals in estrus are inseminated or naturally mated or artificially inseminated 72-96 hours after injection.

- Selexol is injected into all the cattle desired on the farm and those that are in heat are bred. A second injection of Selexol is given 11 days later for those who do not come into heat. Animals are inseminated in estrus after 2-4 days.

- All cattle on the farm receive two injections of Selexol, 11 days apart. Mating is carried out in estrus, which occurs 2-4 days after the second injection. Artificial insemination can be applied 72 and 96 hours after the second injection.

3. Routine use to improve reproductive activities in the early postpartum period: A single dose or two injections of Selexol can be administered to accelerate involution by increasing uterine contraction following delivery.

4. For the purpose of terminating unwanted pregnancies (eg wrong mating). For the purpose of ending unwanted pregnancies (abortion), 5-150 days of pregnancy in cows. applied between days. With the application of Selexol before the 100th day of pregnancy, abortion occurs quickly and safely within 3-5 days. Since the role of placental progesterone rather than luteal progesterone will increase in abortion between the 100th and 150th days of pregnancy, the result of administration may be variable. In this case, if abortion has not occurred 8 days after the application, an injection is made again. Abortion should not occur after the 150th day of pregnancy.

5. For termination of abnormal pregnancies (eg expulsion of the mummified fetus).

Fetal deaths may result in fetal mummification in the uterus. The application of Selexol in any period of pregnancy ensures that the mummified fetus as a result of luteolysis is expelled from the uterus and that the dangers caused by the pathological increase of placental fluids such as hydramniosis and hydrallantois are prevented by evacuation of the uterus.

6. Application for initiation of normal birth: When applied after 270th day of pregnancy in cattle to initiate normal labor, delivery occurs 36-48 hours later.

7. Application in retensio secundinarum, pyometra and chronic metritis.

In such cases, uterine contraction is provided with a single Selexol injection, facilitating the expulsion of the end and removing the fluids in the uterus. This app supports intrauterine therapy. The rise of estrogen activates the uterine defense system.

8. Treatment of luteal cysts: Cystic ovaries may be associated with persistent luteal tissue. With Selexol treatment, this problem can be effectively solved and a return to the normal cycle can be achieved.

In mares

1. In cases of latent and undetectable estrus (calm estrus): Normal-cycling mares may not show all the signs of oestrus or other physiological changes associated with oestrus (eg, edema and relaxation of the cervix), resulting in an inability to determine an optimal mating time. It is more common in mares that are in this breeding season and have never mated. Selexol application provides an estimation of the time of oestrus occurrence.

2. In cases of prolonged diestrus: 20% of mares have a prolonged diestrus period due to the presence of a permanent corpus luteum and this responds to a single injection of Selexol.

3. In cases of resorption following premature fetal deaths: Early fetal death (up to the first 100 days) occurs in 8-10% of mares, followed by fetal resorption and disruption of cycle activity resulting from the permanent corpus luteum. Selexol application can be used to improve these situations.

4. In cases of false pregnancy: Mares with permanent corpus luteum show signs of pregnancy, but upon examination it is determined that they are not pregnant. Selexol application creates luteolysis and restores normal cycle activity.

5. In cases of lactational anoestrus: Lactating mares may not show heat for months. Selexol administration induces resumption according to cycle activity.

6. For abortion before the 45th day of pregnancy: Abortion can be created in mares with Selexol injection until the 35th day of pregnancy. Since endometrial capsules will form after the 35th day of pregnancy, then 4 consecutive injections will be necessary.

7. For the purpose of bringing into estrus suitable for mating time: Selexol application can be used to bring the mares into estrus during the mating season, in order to make optimum use of quality stallions during the mating season.

8. For the synchronization of the estrous cycle: Selexol can be used to synchronize the oestrus cycle of a group of mares. Selexol is applied twice with an interval of 14 days. Insemination can be done 19-21 days after the first application.

USAGE AND DOSAGE

Unless recommended otherwise by the veterinarian:

Pharmacological dose;

Cattle: 500 μg cloprostenol,

Horses: 125-250 μg cloprostenol for horses up to 400 kg, 250-500 μg for horses over 400 kg Practical dose;

Cattle: Single or repeated doses of 2 ml are given as intramuscular injection.

Horses: 0.5-1 ml for horses up to 400 kg, 1-2 ml for horses over 400 kg. The application area should be dry and clean.

SPECIFIC CLINICAL INFORMATION AND WARNINGS FOR TARGET SPECIES

It should be noted that prostaglandins are only effective in the presence of the corpus luteum. In cattle that are not sensitive to the luteolytic effect of prostaglandin, there is a 4-5 day refractory period after ovulation, that is, it will not be effective if used within 5 days after ovulation.

In order for PGs to be effective in pyometra cases in cows and mares, a luteal tissue must be present in the ovaries.

- Luteal cysts are ovarian cysts that clinically usually progress with anoestrus. It is necessary to distinguish follicles from cysts because PGs do not affect follicular cysts. Animals must have normal cycles for successful cycle control and synchronization. Rectal examination prior to drug administration eliminates the risk of insemination of pregnant or anoestrous animals. Special attention should be paid to the nutrition and condition of the treated animals.

- Stress-inducing factors such as sudden changes in feeding patterns, feed monitoring or changing groups during the implementation of the programs should be avoided. If artificial insemination is to be applied, it should be ensured that the quality of the seed and the correct insemination method are selected.

- During the injection, some solution may be wasted or injected into the fat tissue may be effective in not getting the desired result.

UNDESIRED EFFECTS

It has no known side effects at recommended doses in cattle. Heat irregularities, abdominal pain and diarrhea can be seen in mares.

DRUG INTERACTION

Since steroid and nonsteroidal anti-inflammatory drugs inhibit endogenous prostaglandin synthesis, they should not be used together with such drugs.

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

An increase in salivation and body temperature was observed in cattle when administered 5-10 times the recommended dose. When administered at doses much higher than the recommended dose in horses, transient and low levels of sweating, increased respiration and heart rate, diarrhea and abdominal pain were detected. These symptoms are of low severity and transient. In overdose, symptomatic treatment is carried out.

RESIDUAL WARNINGS FOR FOOD PRODUCING ANIMALS

Drug Residue Elimination Period; During the treatment and after the last drug administration, cattle should not be sent to slaughter before 1 day has passed. Residue purification period for milk is '0' days.

CONTRAINDICATIONS

It is not injected intravenously. It should not be applied in the following situations:

In mares with acute or sub-acute disorders of the gastrointestinal tract, in mares with acute or sub-acute respiratory disease (this is an important criterion, since in some animal species injection of prostaglandins can result in acute respiratory problems), death due to rupture of the uterus in the absence of cervical dilatation It should not be used as it can be seen.

Use during pregnancy: Luteolysis during some periods of pregnancy can lead to fetal loss. For this reason, it is not used in pregnant cows and mares, except in cases of unwanted pregnancies and involuntary birth in the last period of pregnancy.

GENERAL PRECAUTIONS

Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children and away from foodstuff.

PRECAUTIONS TO BE TAKEN BY THE APPLICANT AND WARNINGS FOR PHYSICIANS

Prostaglandin can be absorbed through the skin, so especially women of childbearing age, pregnant women and asthmatics should be cautious in the use of this product. In case of accidental spillage on the skin, it should be washed immediately with soapy water. F2 alpha-type prostaglandins can cause bronchospasm in humans, in case of respiratory distress caused by accidental inhalation or injection, bronchodilators such as isoprenaline or salbutamol must be rapidly inhaled.

STORAGE CONDITIONS AND SHELF LIFE

Shelf life is 2 years from the date of manufacture when stored in a dry and cool place (4°C-25°C) away from light.

TRADE DRESS

It is presented in colorless glass bottles of 2, 4, 10, 20 and 50 ml in a cardboard box.

PLACE AND CONDITIONS FOR SALE

Sold in veterinary offices and pharmacies with a veterinarian's prescription (VHR).

PROSPECTUS APPROVAL DATE: 09.08.2021

T.R. MINISTRY OF AGRICULTURE AND FORESTRY MARKETING PERMISSION NO: 27.02.2012-025/0050

NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan – ANKARA-TÜRKİYE

MANUFACTURER COMPANY NAME AND ADDRESS

ALBAFARMA İLAÇ SAN. TİC. A.Ş.

İTOSB (İstanbul Tuzla Organize Sanayi Bölgesi) 8. Cad. No: 11 Tuzla-İSTANBUL