（商品説明）

産道収縮調節剤。

有効成分：デナベリン塩酸塩40mg/ml。

主な対象動物は牛ですが、羊、犬、猫などにも投与可能。

動物の出産時に産道が十分開いていないなど、出産に困難が生じた場合、本剤を投与することにより、子宮の高張性筋収縮を伴う動物の子宮収縮を調節し、産道の軟組織の拡張を促進、スムーズな分娩を促します。

有効成分デナベリン塩酸塩は、平滑筋に弛緩作用を及ぼす痙攣薬です。子宮の分娩を緩和する効果があり、産道の軟部組織の伸展性を高めます。筋肉内注射後、痙攣効果は15〜30分以内に始まり、数時間続きます。

デナベリンは、治療された動物から急速に排泄されます。

食用牛、乳牛に投与後、完全に薬剤が排泄されるまでの経過時間下記の通り。

・牛：肉と内臓：1日

 ・ミルク：24時間

当薬剤の活性物質は非常に優れた耐容性と低毒性を持っています。

（使用法）

下記の量を目安に筋肉内、もしくは皮下注射。

・未経産牛：5-10ml

・牛：10ml

・羊：2〜3 ml

・犬：0.5-1.5ml

・猫：0.25-0.75ml

収縮痙攣効果は投与後10分でピークに達します。

牛では40〜60分、羊では30〜60分の間隔でで繰り返すことができます。

必ず獣医師の指示に従い、適正な容量を適切な方法で投与して下さい。

＜投与のタイミング＞

・未経産牛に使用する場合、分娩を容易にするためには、胎児の一部が子宮頸管内にあり、腹部圧迫が開始されたらすぐに製品を投与する必要があります。

・未経産牛および乳牛での産道の軟組織の拡張を促進するために使用する場合、獣医が軟産道の開口部が不十分であると判断した直後に薬剤を投与できます

・未経産牛および乳牛の何組織が完全に拡張できない場合は、40〜60分後に1回の頻度で投与を繰り返すことがあります。

・過剰投与または静脈内投与の場合、抗コリン作用、例えば心拍数の増加と呼吸数の減少が発生する可能性があります。推奨用量を超えないよう慎重に投与して下さい。

＜禁忌＞

・活性物質またはいずれかの賦形剤に対し、過敏反応を示す場合には使用しないでください。

・胎児の一部が子宮頸管に入っていない場合、および腹部圧迫がまだ開始されていない場合、この薬剤は投与効果がありません。

・薬剤を投与する前に、大きな障害物（例：特大の胎児）がないことを確認する必要がります。障害物が存在する場合は、薬剤投与前に障害物を取り除く必要があります（例：異常な胎位または子宮捻転の矯正等）。

＜使用上の注意＞

・当薬剤は、子宮の筋肉に影響を与える可能性があります。したがって、妊娠中の動物や妊娠前の動物には、投与しないで下さい。

・分娩時にのみ使用してください。妊娠中の他の段階や授乳中は使用しないでください。

・他の動物用医薬品と混合しないでください。オキシトシンまたはその類似体の追加投与の場合、有効成分デナベリンはその効果を増幅する可能性があるため、この活性物質の用量は慎重に選択する必要があります

（使用期限）

ご注文日より１年以上有効のもの

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Sensiblex 40mg/ml solution for injection for cattle 50ml.

Target species

Cattle (cows, heifers)

Indications for use, specifying the target species

Cows, heifers:

- Promotes dilation of the soft tissues of the birth canal in cases where the birth canal is insufficiently opened.

- Regulates uterine contractions in animals with hypertonic muscular contractions of the uterus.

Heifers:

- Promotes dilation of the soft tissues of the birth canal to facilitate parturition.

Contraindications

Do not administer in cases of mechanical obstetrical disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Special warnings for each target species

The product is ineffective if no part of the foetus has entered the cervical canal and if abdominal pressing has not started.

Before administering the product it is important to ensure there are no mechanical obstructions (e.g. oversized foetus). If present, obstructions must be removed prior to product administration (e.g. correction of abnormal presentation or uterine torsion).

Special precautions for use

Special precautions for use in animals

None.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

The product has a potential to affect uterine musculature. Therefore, pregnant women and those women who are attempting to conceive should not handle or administer the product.

Administration should be performed with caution in order to avoid accidental self-injection.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Accidental spillage onto skin or into the eyes should be thoroughly rinsed off with water.

People with known hypersensitivity to denaverine hydrochloride or to any of the excipients should not administer the product.

Wash hands after use.

Adverse reactions (frequency and seriousness)

Increased restlessness; swellings at the injection site; absent or insufficient effectiveness necessitating further obstetric measures.

Use during pregnancy, lactation or lay

Use at the time of parturition only. Not for use during other stages of pregnancy or during lactation.

Interaction with other medicinal products and other forms of interaction

The product should not be mixed with other veterinary medicinal products. In the case of additional administration of oxytocin or its analogues, the dose of this active substance must be carefully selected because denaverine may amplify its effects.

Amounts to be administered and administration route

For intramuscular use.

Heifers: 10.0 ml product (400 mg Denaverine hydrochloride / animal)

Cows:  10.0 ml product (400 mg Denaverine hydrochloride / animal)

Timing of product administration:

- Use in heifers to facilitate parturition: the product should be administered as soon as parts of the foetus are within the cervical canal and abdominal pressing has started.

- Use in heifers and cows to promote dilation of the soft tissues of the birth canal: the product can be administered immediately after the veterinary surgeon has determined that insufficient opening of the soft birth canal is present (please also refer to section 4.3 [contraindications] and 4.4 [special warnings] of the SPC).

In cases where full dilation is not achieved, product administration may be repeated once after 40 - 60 minutes.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose or intravenous application, anticholinergic effects, e.g. increased heart and decreased respiration rate may occur. Do not exceed the recommended dose.

Withdrawal period(s)

Cattle:   Meat and offal: 1 day

 Milk:   24 hours

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Genitourinary system and sex hormones; other gynaecologicals

ATCvet code: QG02CX90

Pharmacodynamic properties

Denaverine hydrochloride is a spasmolytic agent with a relaxant effect on smooth muscle. It has a relaxing effect on the uterus sub partu and increases the distensibility of the soft-tissue of the birth canal. Following intramuscular injection the spasmolytic effect commences within 15 to 30 minutes and lasts for several hours. The mechanism of action is not known.

Pharmacokinetic particulars

Denaverine is excreted rapidly from the treated animals.

PHARMACEUTICAL PARTICULARS

List of excipients

Benzyl alcohol (E1519)

Propylene glycol

Hydrochloric acid (for pH adjustment)

Water for injections

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:

2 years

Shelf life after first opening the immediate packaging:

28 days

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Nature and composition of immediate packaging

Vial of colourless glass, type I, with a fluorinated bromobutyl rubber stopper and an aluminium cap;

1 vial (10 ml) in a cardboard box.

1 vial (50 ml) in a cardboard box.

Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.