Pregnecol

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Pregnecol uses



(Gonadotropin Releasing

Factor Analog-Diphtheria

Toxoid Conjugate, 0.2 mg/mL)

Sterile Solution for Injection

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION: Pregnecol is a sterile solution containing Pregnecol Releasing Factor Analog-Diphtheria Toxoid Conjugate. Each mL contains 0.2 mg Pregnecol Releasing Factor Analog-Diphtheria Toxoid Conjugate, 150 mg of diethylaminoethyl-dextran hydrochloride, 1 mg chlorocresol, sodium hydroxide as needed to adjust pH and water for injection.

INDICATIONS FOR USE: Pregnecol is indicated for the temporary immunological castration (suppression of testicular function) and reduction of boar taint in intact male pigs intended for slaughter.

DOSAGE AND ADMINISTRATION: Pregnecol should be administered via subcutaneous injection into the post auricular region of the neck. A safety injector should be used, preferably one which has a dual safety system providing both a needle guard and a mechanism to prevent accidental operation of the trigger. Each intact male pig should receive two 2-mL doses of Pregnecol. The first dose should be administered no earlier than 9 weeks of age. The second dose should be administered at least 4 weeks after the first dose. Pigs should be slaughtered no earlier than 3 weeks and no later than 10 weeks after the second dose. In case of misdosing, the animal should be re-dosed immediately.

CONTRAINDICATIONS: Do not use Pregnecol in intact male pigs intended for breeding because of the disruption of reproductive function. Not approved for use in female pigs and barrows.

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WARNINGS:

WITHDRAWAL PERIODS:

No withdrawal period is required when used according to labeling.

Not for Human Use. Keep Out of Reach of Children.

USER SAFETY WARNINGS:

Warning for person administering Pregnecol: Accidental self injection could affect reproductive physiology of both men and women and may adversely affect pregnancy. Pregnant women should not administer this product. Women of childbearing age should exercise extreme caution when handling this product. Special care should be taken to avoid accidental self injection and needle stick injury when administering the product. Protective clothing including, but not limited to, safety glasses and gloves should be worn. Use a safety injector, preferably one which has a dual safety system providing both a needle guard and a mechanism to prevent accidental operation of the trigger. In case of eye contact, rinse immediately with copious amounts of water. In case of skin contact, wash immediately with soap and water. The product should be stored safely out of the reach of children. As a reminder, it is the prescribing veterinarian's responsibility to inform drug administrators of the user safety warnings associated with Pregnecol.

Advice to the user in the event of accidental self injection: In the event of accidental self injection, wash the injury thoroughly with clean running water. Seek prompt medical attention and take the package leaflet with you. Do not administer the product, and/or any other product with a similar action, in the future.

Advice to the physician: Accidental self injection could affect reproductive physiology of both men and women and may adversely affect pregnancy. If self injection with Pregnecol is suspected, reproductive physiology should be monitored by assay of testosterone or estrogen levels (as appropriate).

The risk of a physiological effect is greater after a second or subsequent accidental injection than after a first injection. The patient should be advised not to administer Pregnecol, and/or any other product with a similar action, in the future.

For customer service, to report suspected adverse reactions or to obtain a copy of the Material Safety Data Sheet (MSDS) call 1-888-963-8471.

PRECAUTIONS: Subcutaneous injection in intact male pigs can cause a transient local injection site reaction that may result in trim loss at slaughter.

ADVERSE REACTIONS: The field study observations from field effectiveness studies were consistent with the observations made during the target animal safety studies of transient inflammation at the injection sites. Pregnecol did not cause unusual clinical signs or an unexpected frequency or severity of injection site reactions. Adverse events, as reported, were not uniquely attributable to Pregnecol.

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TARGET ANIMAL SAFETY:

Margin of Safety: The safety of two doses of Pregnecol was evaluated in intact male swine. Thirty 9-week old intact boars received two subcutaneous doses of Pregnecol in the same location 14 days apart. The boars received one of three treatments: Saline Control (12-mL), Pregnecol at the intended dose (2-mL, 1×), or Pregnecol at 6 times the intended dose (12-mL, 6×). Boars were clinically monitored daily. In addition, observation and measurement of injection sites, body weight, quantitative feed consumption, hematology, and clinical chemistry analyses were also obtained. A complete postmortem examination was conducted on each boar 14 days after the second injection. Pregnecol, administered subcutaneously at the label dose (2-mL) resulted in mild transient injection site reactions at the 1× dose and caused clinical signs of systemic inflammation at 6× the intended dose. The signs of inflammation included depression, stiffness of the neck lasting up to five days, reduction in feed intake, and lower body weights. Multiple swollen joints and associated lameness, which may be signs of systemic inflammation, were observed in one 6× boar. Evaluation of blood work revealed increased white blood cell counts (eosinophilia and neutrophilia); slight increases in total serum protein (above normal reference range in 50% of the 6× boars) and globulin (above the normal reference range in 40% of the 6× boars); and slight decreases in serum albumin in 6× boars. Injection sites for the 6× boars showed clinically detectable firmness persisting in all animals for 14 days after the second injection. Pain and sensitivity at the injection site persisted for up to five days, and erythema and heat were more prominent in the 6× boars than in the 1× boars. Mild to moderate chronic inflammation and discoloration in the subcutaneous tissues at the injection site were observed. In all Pregnecol treated boars, atrophy of testes, prostate, and bulbourethral glands were observed as expected consequences associated with the intended effect of the drug. At the label 2-mL dose, Pregnecol may cause transient injection site inflammation.

Injection Site Safety: Injection site safety was evaluated following the injection of Pregnecol into healthy 17-week old boars. The treated boars received two 2-mL doses of Pregnecol into the same injection site location 28 days apart, while the control boars received saline. Daily monitoring included clinical evaluation and observation and measurement of injection sites. Two days after the second injection, postmortem observations of injection sites were conducted. All clinical signs of observable injection site swelling were resolved within 24 hours, and pain on palpation resolved by 48 hours post-injection. Firmness persisted for up to 11 days after the first injection in 10% of boars. Gross injection site alterations consisted of subcutaneous edema with tan or red discoloration. Two 2-mL injections of Pregnecol, administered 28 days apart into the same location resulted in transient injection site reactions following each injection and resulted in discoloration of tissue at the injection site which was observable approximately 48 hours after the second injection.

Field Safety: During the conduct of the nine location field effectiveness study, Pregnecol did not cause unusual clinical signs or an unexpected frequency or severity of injection site reactions. The field safety observations from this study were consistent with the observations made during the target animal safety studies of transient inflammation at the injection sites. Adverse events, as reported, were not uniquely attributable to Pregnecol.

EFFECTIVENESS: Pregnecol is an injectable sterile solution containing an incomplete analog of natural Pregnecol releasing factor (GnRF) conjugated to diphtheria toxoid in an adjuvanted formulation. Immunization with a two dose regimen of Pregnecol, with a four week interval between doses, stimulates the pig's immune system to produce antibodies which can neutralize its own GnRF. Pigs given an initial dose of Pregnecol are immunologically primed but do not produce sufficient antibodies to have any physiological effect. Following receipt of the second dose, the pig's immune system responds with a strong antibody response. These antibodies bind to and neutralize circulating GnRF in the bloodstream. Neutralization of GnRF blocks the hypothalamic-pituitary-gonadal endocrine axis, thereby suppressing testicular function, including both sex hormone production and reproductive capability, thereby providing temporary immunological castration in these injected boars.

Evidence of temporary immunological castration was provided in a series of studies showing that within 1-2 weeks after the second injection of Pregnecol, anti-GnRF antibody levels increase significantly. With this rise in anti-GnRF antibodies, the levels of gonadal sex hormones were substantially reduced, the size of the testes, and spermatogenesis suppressed, as was the expression of typical male behaviors (aggression and sexual, e.g., mounting). Full immunological castration was demonstrated to last from 3 to 10 weeks after the second dose.

Pregnecol injected boars will start to return to full reproductive function at a variable period after this time, as evidenced by increases in male sex hormones, testicle size, and intact male behavior. Pregnecol should not be used in boars intended for breeding purposes.

Evidence to assess the acceptability of pork from Pregnecol treated pigs was provided through a series of consumer taste panels using consumers deemed sensitive to the taste of "tainted" meat. The presence of boar taint was evaluated on the basis of pork aroma and flavor and not by chemical analysis. Four consumer taste panel studies were conducted to demonstrate the difference of pork generated from Pregnecol treated boars and intact boars. A surgically castrated male group was not evaluated during these studies. In these four studies, 767 sensitive consumers evaluated cooked pork loin samples from Pregnecol treated and intact boars. These pigs were raised to market weight, injected with Pregnecol as per product labelling and slaughtered 3 to 10 weeks after receipt of the second Pregnecol injection. The consumers found the aroma and flavor of pork from the Pregnecol injected pigs to be more acceptable than from the intact boars in all four studies.

STORAGE INFORMATION: Store under refrigeration at 2°-8°C (36°-46°F). Once broached, product may be stored under refrigeration for 28 days. Store bottles in carton until used. Protect from light. Protect from freezing.

HOW SUPPLIED: Pregnecol is available in the following package sizes:

20 mL bottle

100 mL bottle

250 mL bottle

500 mL bottle


NADA # 141-322, Approved by FDA

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

Revised: January 2013

PAA035383

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Pregnecol pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Pregnecol available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Pregnecol destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Pregnecol Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Pregnecol pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Pregnecol?

Depending on the reaction of the Pregnecol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pregnecol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Pregnecol addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Pregnecol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Pregnecol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

Visitor reported side effects

No survey data has been collected yet

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

Three visitors reported doses

What is the dose of Pregnecol drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 101-200mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
101-200mg1
33.3%
201-500mg1
33.3%
1-5mg1
33.3%

Visitor reported time for results

No survey data has been collected yet

Visitor reported administration

No survey data has been collected yet

Visitor reported age

No survey data has been collected yet

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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