Адекван для собак инструкция по применению

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Активное вещество – гликозаминогликан в виде полисульфата, представляющий клинико-фармакологическую группу хондропротекторов. В качестве вспомогательного компонента используется вода для инъекций.

Форма выпуска

Лекарственное средство выпускается в форме прозрачного бесцветного раствора без посторонних включений. Расфасован он в стеклянные флаконы, укупоренные пластиковыми пробками и снабженные защитными алюминиевыми колпачками. Вторичная упаковка – картонная коробка, внутри которой находится подробная инструкция по применению.

Фармакологическое действие

Хондропротекторное. Стимулятор регенерации хрящевых суставных прокладок.

Фармакодинамика препарата

Под воздействием полисульфатированного гликозаминогликана происходит ингибирование катаболических ферментов. Именно эти биоактивные вещества ответственны за разрушение хрящевых суставных прокладок. Например, протеиназы, ферменты из класса гидролаз, расщепляют пептидные связи между аминокислотами внутри белков. Так как их много в синовиальной жидкости, то протеогликаны хрящей разрушаются особенно быстро.

Основной компонент препарата снижает активность эластаз, металлопротеаз, катепсина, гиалуронидазы – катаболических ферментов, концентрация которых повышается при деструктивно-дегенеративных суставных патологиях. Благодаря этому возрастает выработка коллагена, протеогликанов, гиалуроновой кислоты.

В ходе клинических исследований было установлено, что полисульфатированный гликозаминогликан способен тормозить выработку простагландинов – провоспалительных медиаторов. А также стимулировать биосинтез белков, необходимых для построения хряща.

После парентерального введения раствора примерно спустя полчаса активное вещество обнаруживается в органах и тканях. Его низкая молекулярная масса обеспечивает накопление непосредственно в синовиальной жидкости. Последующее поступление гликозаминогликана внутрь хрящевых прокладок осуществляется за счет диффузии.

Показания к применению

Препарат используется в ветеринарной практике для комплексной терапии деструктивно-дегенеративных суставных патологий у собак:

• деформирующих остеоартрозов, осложненных соединительнотканной дисплазией;
• остеоартрозов, спровоцированных предшествующими травмами.

С помощью препарата проводится лечение заболеваний суставов с воспалительной составляющей, принявших хроническое течение. Он хорошо зарекомендовал себя в терапии тендинитов (воспалительных процессов в области сухожилия). После курсового введения раствора выраженность хромоты существенно снижалась.

Противопоказания

Абсолютное противопоказание – индивидуальная непереносимость активного ингредиента. Адекван не рекомендован животным с расстройствами работы свертывающей системы крови. Под контролем ветеринара и с осторожностью выполняется лечение при сниженной функциональной активности печени, почек.

Побочные эффекты

В клинической практике отмечены редкие случаи развития местных и системных побочных реакций. Проявляются они следующим образом:

• болезненными ощущениями в области инъекции;
• диареей;
• кровотечениями.

Зарегистрированные инциденты единичны, обратимы, поэтому прекращения лечения собак не требуется. Проводится симптоматическая терапия для устранения побочных эффектов.

Совместимость с другими препаратами

Не было отмечено случаев нежелательно взаимодействия со средствами, которые используются одновременно для лечения дегенеративных поражений опорно-двигательного аппарата. Препарат хорошо сочетается с миорелаксантами, анальгетиками, другими стимуляторами регенерации суставных тканей. Запрещено использовать лекарственные средства, в составе которых присутствуют хондропротекторы. Подобное сочетание может привести к усилению эффектов, включая побочные.

Применение препарата

Если индивидуальный режим дозирования не определен, препарат применяется в стандартной дозе. Она составляет 4,4 мг/кг массы тела.

Отсутствие ожидаемых результатов после месяца лечения – повод для обращения к ветеринару. Он уточнит диагноз, дополнит терапевтическую схему другими средствами или назначит более эффективный действующий аналог.

Передозировка

Патологическое состояние маловероятно, так как активное вещество препарата родственно гликозаминогликанам, постоянно биосинтезирущимся в организме животного. После введения раствора в дозе, многократно превышающей стандартную, повышается риск выраженных побочных проявлений. Следует обратиться за медицинской помощью для симптоматического лечения, ускоренного выведения излишков полисульфатированного гликозаминогликана.

Условия продажи

По рецепту врача.

Условия хранения

Препарат следует хранить при комнатной температуре в местах, защищенных от света. Беречь от детей.

Применение при беременности и кормлении грудью

Вынашивание беременности и лактация в перечень противопоказаний не включены. Эмбриотоксического и мутагенного действия у лекарственного средства обнаружено не было.

Влияние на способность к вождению автотранспорта и управлению механизмами

Лекарственное средство предназначено только для лечения животных.

Особые указания

Препарат разрешено использовать после купирования воспалительных процессов. При инфекционных суставных поражениях требуется предварительное проведение антибактериальной, противовирусной или противогрибковой терапии. После спада воспаления раствор применяется в стандартных дозах.

Отзывы и рекомендации врачей и пациентов

Деструктивно-дегенеративные заболевания суставов медленно, но упорно прогрессируют. Единственной группой препаратов, способных затормозить процесс разрушения хрящевых прокладок являются хондропротекторы, в том числе Адекван. Перед его поступлением в продажу производителем были инициированы лабораторные и клинические исследования. Согласно их результатам хондропротектор эффективен при остеоартрозах, независимо от происхождения.

После завершения лечебного курса улучшается состав синовия – естественного амортизатора для суставов. Это становится причиной устранения тугоподвижности. По мере накопления активного вещества в суставной полости проявляются его обезболивающий и противовоспалительный эффекты.

При каких заболеваниях применяют?

• Травматическая хромота у лошадей
• артроз у животных
• острые тендениты
• дегенеративные заболевания суставов у животных

Company: American Regent

polysulfated glycosaminoglycan

Solution 100 mg/mL in a 5 mL preserved Multiple dose vial for intramuscular use in dogs.

Adequan Canine Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

The active ingredient in Adequan^® Canine is polysulfated glycosaminoglycan (PSGAG). Polysulfated glycosaminoglycan is a semi-synthetic glycosaminoglycan prepared by

extracting glycosaminoglycans (GAGs) from bovine tracheal cartilage. GAGs are polysaccharides composed of repeating disaccharide units. The GAG present in PSGAG is principally chondroitin sulfate containing 3 to 4 sulfate esters per disaccharide unit. The molecular weight for PSGAG used in the manufacture of Adequan^® is 3,000 to 15,000 daltons. Each mL of Adequan^® Canine contains 100 mg of PSGAG, 0.9% v/v benzyl alcohol as a preservative, and water for injection q.s. to 1 mL. Sodium hydroxide and/or hydrochloric acid added when necessary to adjust pH. The solution is clear, colorless to slightly yellow.

Pharmacology

The specific mechanism of action of Adequan^® in canine joints is not known. PSGAG is characterized as a “disease modifying osteoarthritis drug.” Experiments conducted in vitro have shown PSGAG to inhibit certain catabolic enzymes which have increased activity in inflamed joints, and to enhance the activity of some anabolic enzymes. For example, PSGAG has been shown to significantly inhibit serine proteinases. Serine proteinases have been demonstrated to play a role in the Interleukin-l mediated degradation of cartilage proteoglycans and collagen. PSGAG is reported to be an inhibitor of Prostaglandin E2 (PGE2) synthesis. PGE2 has been shown to increase the loss of proteoglycan from cartilage. PSGAG has been reported to inhibit some catabolic enzymes such as elastase, stromelysin, metalloproteases, cathepsin B1, and hyaluronidases, which degrade collagen, proteoglycans, and hyaluronic acid in degenerative joint disease. Anabolic effects studied include ability to stimulate the synthesis of protein, collagen, proteoglycans, and hyaluronic acid in various cells and tissues in vitro. Cultured human and rabbit chondrocytes have shown increased synthesis of proteoglycan and hyaluronic acid in the presence of PSGAG. PSGAGs have shown a specific potentiating effect on hyaluronic acid synthesis by synovial membrane cells in vitro.

Absorption, distribution, metabolism, and excretion of PSGAG following intramuscular injection have been studied in several species, including rats, rabbits, humans, horses and dogs.

Studies in rabbits showed maximum blood concentrations of PSGAG following IM injection were reached between 20 to 40 minutes following injection, and that the drug was distributed to all tissues studied, including articular cartilage, synovial fluid, adrenals, thyroid, peritoneal fluid, lungs, eyes, spinal cord, kidneys, brain, liver, spleen, bone marrow, skin, and heart.

Following intramuscular injection of PSGAG in humans, the drug was found to be bound to serum proteins. PSGAG binds to both albumin and chi- and beta-globulins and the extent of the binding is suggested to be 30 to 40%. Therefore, the drug may be present in both bound and free form in the bloodstream. Because of its relatively low molecular weight, the synovial membrane is not a significant barrier to distribution of PSGAG from the bloodstream to the synovial fluid. Distribution from the synovial fluid to the cartilage takes place by diffusion. In the articular cartilage the drug is deposited into the cartilage matrix.

Serum and synovial fluid distribution curves of PSGAG have been studied in dogs and appear similar to those found in humans and rabbits.

In rabbits, metabolism of PSGAG is reported to take place in the liver, spleen, and bone marrow. Metabolism may also occur in the kidneys. PSGAG administered intramuscularly and not protein bound or bound to other tissues is excreted primarily via the kidneys, with a small proportion excreted in the feces.

Toxicity: In a subacute toxicity study, 32 adult beagle dogs (4 males and 4 females per treatment group) received either 0.9% saline solution or PSGAG at a dose of 5 mg, 15 mg, or 50 mg per kg of body weight (approximately 2.3, 6.8, or 22.7 mg/lb), via intramuscular injection twice weekly for 13 weeks. PSGAG doses represent approximately 1X, 3X, and 10X the recommended dosage of 2 mg/lb, and more than 3 times the recommended 4-week duration of treatment. Necropsies were performed 24 hours after the final treatment. During week 12, one dog in the 50 mg/kg dosage group developed a large hematoma at the injection site which necessitated euthanasia. No other mortalities occurred during the treatment period. Statistically significant changes in the 50 mg/kg group included increased prothrombin time, reduced platelet count, an increase in ALT and cholesterol, and increased liver and kidney weights. Increased cholesterol and kidney weights were also noted in the 15 mg/kg group. Microscopic lesions were noted in the liver (Kupffer cells containing eosinophilic foamy cytoplasm), kidneys (swollen, foamy cells in the proximal convoluted tubules), and lymph nodes (macrophages with eosinophilic foamy cytoplasm) in the 15 mg/kg and 50 mg/kg groups. Intramuscular inflammation, hemorrhage, and degeneration were seen in all 3 PSGAG treated groups; the incidence and severity appeared dose related.

Efficacy: Efficacy of Adequan^® Canine was demonstrated in two studies. A laboratory study using radiolabeled PSGAG established distribution of PSGAG into canine serum and synovial fluid following a single intramuscular injection of 2 mg/lb. A clinical field trial was conducted in dogs diagnosed with radiographically-confirmed traumatic and/or degenerative joint disease of 1 or 2 joints. Joints evaluated included hips, stifles, shoulders, hocks and elbows. Fifty-one dogs were randomly assigned to receive either Adequan^® Canine at 2 mg/lb of body weight or 0.9% saline. Both treatments were administered by intramuscular injection twice weekly for 4 weeks (8 injections total). Investigators administering treatment and evaluating the dogs were unaware of the treatment assignment. A total of 71 limbs in 51 dogs were evaluated. Of these, 35 limbs in 24 dogs were in the Adequan^® Canine treated group. Each lame limb was scored for lameness at a walk, lameness at a trot, pain, range of motion, and functional disability. The scores for the individual parameters were combined to determine a total orthopedic score. At the end of the treatment period, dogs treated with Adequan^® Canine showed a statistically significant improvement in range of motion and total orthopedic score over placebo treated control dogs.

Adequan Canine Indications and Usage

Adequan^® Canine is recommended for intramuscular injection for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints.

Contraindications

Do not use in dogs showing hypersensitivity to PSGAG. PSGAG is a synthetic heparinoid; do not use in dogs with known or suspected bleeding disorders.

Precautions

The safe use of Adequan^® Canine used in breeding, pregnant, or lactating dogs has not been evaluated. Use with caution in dogs with renal or hepatic impairment.

Adverse Reactions

In the clinical efficacy trial, 24 dogs were treated with Adequan^® Canine twice weekly for 4 weeks. Possible adverse reactions were reported after 2.1% of the injections. These included transient pain at the injection site (1 incident), transient diarrhea (1 incident each in 2 dogs), and abnormal bleeding (1 incident). These effects were mild and self-limiting and did not require interruption of therapy.

Post Approval Experience (2014)

The following adverse events are based on voluntary, post-approval reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The signs reported are listed in decreasing order of reporting frequency.

Vomiting, anorexia, depression/lethargy, diarrhea.

In some cases, death has been reported.

To report suspected adverse drug events, contact American Regent, Inc. at 1- 888-354-4857. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Warnings

Not for use in humans. Keep this and all medications out of reach of children.

Dosage and Administration

Practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once.

The vial stopper may be punctured a maximum of 10 times.

The recommended dose of Adequan^® Canine is 2 mg/lb body weight (.02 mL/lb, or 1 mL per 50 lb), by intramuscular injection only, twice weekly for up to 4 weeks (maximum of 8 injections). Do not exceed the recommended dose or therapeutic regimen. Do not mix Adequan^® Canine with other drugs or solvents.

Storage Conditions: Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Avoid prolonged exposure to temperatures ≥ 40°C (104°F).

Use within 28 days of first puncture and puncture a maximum of 10 times. Dispose of spent needles in accordance with all federal, state and local environmental laws.

How Supplied

Adequan^® Canine Solution 100 mg/mL in a 5 mL preserved multiple dose vial.

NDC 10797-975-02

5 mL Multiple Dose Vials

Packaged 2 vials per box

AMERICAN REGENT, INC., ANIMAL HEALTH, Shirley, NY 11967

(1-888-354-4857)

Approved by FDA under NADA # 141-038

Made in U.S.A.

Rev. 9/2021

IN975

MG #44454

CPN: 1039000.5

Solution 100 mg/mL in a 5 mL preserved
Multiple dose vial for intramuscular use in dogs.

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description: The active ingredient in Adequan^® Canine is polysulfated glycosaminoglycan (PSGAG).
Polysulfated glycosaminoglycan is a semi-synthetic glycosaminoglycan prepared by extracting glycosaminoglycans (GAGs) from bovine tracheal cartilage.
GAGs are polysaccharides composed of repeating disaccharide units. The GAG present in PSGAG is principally chondroitin sulfate containing 3 to 4 sulfate
esters per disaccharide unit. The molecular weight for PSGAG used in the manufacture of Adequan^® is 3,000 to 15,000 daltons.

Each mL of Adequan^® Canine contains 100 mg of PSGAG, 0.9% v/v benzyl alcohol as a preservative, and water for injection q.s. to 1 mL. Sodium hydroxide and/or
hydrochloric acid added when necessary to adjust pH. The solution is clear, colorless to slightly yellow.

Pharmacology: The specific mechanism of action of Adequan^® in canine joints is not known. PSGAG is characterized as a «disease modifying osteoarthritis drug».
Experiments conducted in vitro have shown PSGAG to inhibit certain catabolic enzymes which have increased activity in inflamed joints, and to enhance the activity
of some anabolic enzymes. For example, PSGAG has been shown to significantly inhibit serine proteinases. Serine proteinases have been demonstrated to play a role
in the Interleukin-l mediated degradation of cartilage proteoglycans and collagen. PSGAG is reported to be an inhibitor of Prostaglandin E2 (PGE2) synthesis.
PGE2 has been shown to increase the loss of proteoglycan from cartilage. PSGAG has been reported to inhibit some catabolic enzymes such as elastase, stromelysin,
metalloproteases, cathepsin B1, and hyaluronidases, which degrade collagen, proteoglycans, and hyaluronic acid in degenerative joint disease. Anabolic effects
studied include ability to stimulate the synthesis of protein, collagen, proteoglycans, and hyaluronic acid in various cells and tissues in vitro. Cultured human
and rabbit chondrocytes have shown increased synthesis of proteoglycan and hyaluronic acid in the presence of PSGAG. PSGAGs have shown a specific potentiating
effect on hyaluronic acid synthesis by synovial membrane cells in in vitro.

Absorption, distribution, metabolism, and excretion of PSGAG following intramuscular injection have been studied in several species, including rats, rabbits, humans, horses and dogs.

Studies in rabbits showed maximum blood concentrations of PSGAG following IM injection were reached between 20 to 40 minutes following injection, and that the drug was distributed
to all tissues studied, including articular cartilage, synovial fluid, adrenals, thyroid, peritoneal fluid, lungs, eyes, spinal cord, kidneys, brain, liver, spleen, bone marrow,
skin, and heart.

Following intramuscular injection of PSGAG in humans, the drug was found to be bound to serumproteins. PSGAG binds to both albumin and chi- and beta-globulins
and the extent of the binding is suggested to be 30 to 40%. Therefore, the drug may be present in both bound and free form in the bloodstream. Because of its relatively low molecular
weight, the synovial membrane is not a significant barrier to distribution of PSGAG from the bloodstream to the synovial fluid. Distribution from the synovial fluid to the cartilage
takes place by diffusion. In the articular cartilage the drug is deposited into the cartilage matrix.

Serum and synovial fluid distribution curves of PSGAG have been studied in dogs and appear similar to those found in humans and rabbits.

In rabbits, metabolism of PSGAG is reported to take place in the liver, spleen, and bone marrow. Metabolism may also occur in
the kidneys. PSGAG administered intramuscularly and not protein bound or bound to other tissues is excreted primarily via the kidneys, with a small proportion excreted in the feces.

Toxicity: In a subacute toxicity study, 32 adult beagle dogs (4 males and 4 females per treatment group) received either 0.9% saline solution or PSGAG at a dose of 5 mg, 15 mg,
or 50 mg per kg of body weight (approximately 2.3, 6.8, or 22.7 mg/lb), via intramuscular injection twice weekly for 13 weeks. PSGAG doses represent approximately 1X, 3X, and
10X the recommended dosage of 2 mg/lb, and more than 3 times the recommended 4-week duration of treatment. Necropsies were performed 24 hours after the final treatment.
During week 12, one dog in the 50 mg/kg dosage group developed a large hematoma at the injection site which necessitated euthanasia. No other mortalities occurred during
the treatment period. Statistically significant changes in the 50 mg/kg group included increased prothrombin time, reduced platelet count, an increase in ALT and cholesterol,
and increased liver and kidney weights. Increased cholesterol and kidney weights were also noted in the 15 mg/kg group. Microscopic lesions were noted in the liver
(Kupffer cells containing eosinophilic foamy cytoplasm), kidneys (swollen, foamy cells in the proximal convoluted tubules), and lymph nodes (macrophages with eosinophilic foamy cytoplasm)
in the15 mg/kg and 50 mg/kg groups. Intramuscular inflammation, hemorrhage, and degeneration were seen in all 3 PSGAG treated groups; the incidence and severity appeared dose related.

Efficacy: Efficacy of Adequan^® Canine was demonstrated in two studies. A laboratory study using radiolabeled PSGAG established distribution of PSGAG
into canine serum and synovial fluid following a single intramuscular injection of 2 mg/lb. A clinical field trial was conducted in dogs diagnosed with
radiographically-confirmed traumatic and/or degenerative joint disease of 1 or 2 joints. Joints evaluated included hips, stifles, shoulders, hocks and elbows.
Fifty-one dogs were randomly assigned to receive either Adequan^® Canine at 2 mg/lb of body weight or 0.9% saline.

Both treatments were administered by intramuscular injection twice weekly for 4 weeks (8 injections total). Investigators administering treatment and evaluating
the dogs were unaware of the treatment assignment. A total of 71 limbs in 51 dogs were evaluated. Of these, 35 limbs in 24 dogs were in the Adequan^® Canine treated group.
Each lame limb was scored for lameness at a walk, lameness at a trot, pain, range of motion, and functional disability. The scores for the individual parameters were
combined to determine a total orthopedic score. At the end of the treatment period, dogs treated with Adequan^® Canine showed a statistically significant improvement in
range of motion and total orthopedic score over placebo treated control dogs.

Indications and Usage: Adequan^® Canine is recommended for intramuscular injection for the control of signs associated with non-infectious degenerative and/or
traumatic arthritis of canine synovial joints.

Contraindications: Do not use in dogs showing hypersensitivity to PSGAG. PSGAG is a synthetic heparinoid; do not use in dogs with known or suspected bleeding disorders.

Precautions: The safe use of Adequan^® Canine used in breeding, pregnant, or lactating dogs has not been evaluated. Use with caution in dogs with renal or hepatic impairment.

Adverse Reactions: In the clinical efficacy trial, 24 dogs were treated with Adequan^® Canine twice weekly for 4 weeks. Possible adverse reactions were reported after
2.1% of the injections. These included transient pain at the injection site (1 incident), transient diarrhea (1 incident each in 2 dogs), and abnormal bleeding (1 incident).
These effects were mild and self-limiting and did not require interruption of therapy.

Post Approval Experience (2014)

The following adverse events are based on voluntary, post-approval reporting. Not all adverse reactions are reported to FDA/CVM.
It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.
The signs reported are listed in decreasing order of reporting frequency.

Vomiting, anorexia, depression/lethargy, diarrhea.

In some cases, death has been reported.

To report suspected adverse drug events, contact American Regent, Inc. at 1-888-354-4857. For additional information about adverse drug
experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/Animal Veterinary/SafetyHealth.

Warnings: Not for use in humans. Keep this and all medications out of reach of children.

DOSAGE AND ADMINISTRATION:
Practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections.
Adequately clean and disinfect the stopper prior to entry with a sterile needle and syringe. Use only sterile needles,
and use each needle only once.

The vial stopper may be punctured a maximum of 10 times.
The recommended dose of Adequan^® Canine is 2 mg/lb body weight (.02 mL/lb, or 1 mL per 50 lb),
by intramuscular injection only, twice weekly for up to 4 weeks (maximum of 8 injections). Do not exceed the recommended dose or therapeutic regimen.
Do not mix Adequan^® Canine with other drugs or solvents.

Storage Conditions:
Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F)
(See USP Controlled Room Temperature). Avoid prolonged exposure to temperatures ≥ 40°C (104°F).

Use within 28 days of first puncture and puncture a maximum of 10 times.
Dispose of spent needles in accordance with all federal, state and local environmental laws.

How Supplied: Adequan^® Canine Solution 100 mg/mL in a 5 mL preserved multiple dose vial.

NDC 10797-975-02      5 mL Multiple Dose Vials       Packaged 2 vials per box

IN975
MG #44454