Solution For Injection

For Veterinary Use Only

Composition:

Each ml contain:
Diphenhydramine Hydrochloride 20 mg

Properties:

Diphenhydramine is an antihistamine that belongs to the group of antagonists of the H1 receptors.
It acts by competitive inhibition of histamine by occupying the H1 relays cell phones. However, if histamine is found in large amounts, it can displace drug, since it does not reduce the amount of histamine released or accelerate its destruction The pharmacological action responds to a general scheme for all H1-blockers and includes effects on various systems and devices. Smooth muscle: antagonism of the spastic action of histamine, with a marked effect on the gastrointestinal tract and respiratory tract. The main action is bronchodilator, conferring protection to the individual against anaphylactic shock or mediated allergic reaction by leukotrienes. Vascular system: partially inhibits arterial hypotension and increased permeability histamine-induced vascular disease. Adrenal medulla and autonomic ganglion: suppression of the stimulating effects of histamine on the chromaffin cells of the marrow and the autonomic ganglia. Central nervous system: the group of ethanolamines, within which is the diphenhydramine (hydrochloride), is the most prone of the H1-blockers to produce depression central and drowsiness.
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Indications:

• Allergic respiratory disease or allergic manifestations of any kind.
• Histamine’s effects to reduce itchiness associated with allergies.
• It can also be used as an additional treatment for itching related to certain types of cancers (e.g., mast cell tumors).
• Treatment or preventative for motion sickness.
• It is occasionally used as a tranquilizer to calm animals or to treat signs (such as tremors or rigidity) associated with certain drugs or toxins.
• Treatment of Allergies cause histamine release, which causes itchy skin. Diphenhydramine blocks

Target species:

Horses not intended for human consumption – Dogs.

Dosage & Administration:

Route:
Horses: Intravenous or Intramuscular injection.
Dogs: Intravenous injection.
For Whole product:
Horses: 1.42 – 2.85 mL of product / 50 kg .b.w. Every 12 hours(Intramuscular or intravenous injection).
Dogs: 1.14 – 2.85 mL of product /10 kg. b.w. every 12 hours (intravenous injection).

Warning & precautions:

• Do not use in equidae whose meat or milk is intended for human consumption.
• This medicine does not contain any antimicrobial preservatives.

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Special precautions for use in animals:

• With glaucoma as it may make it worse.
• That have problems urinating, prostate enlargement, thyroid problems, or heart disease.
• Working dogs (eg, guide dogs, search dogs, hunting dogs, sled dogs, rescue dogs) may become sleepy and unable to perform their duties.
• Who are nursing mothers as diphenhydramine crosses over into the milk and may have an effect on the newborns
• If your animal matches any of these conditions, talk to your veterinarian about the possible risks of using the drug versus the benefits it may have.
• Other drugs can interact with diphenhydramine, so be sure to tell your veterinarian and pharmacist what medications (including vitamins, supplements, or herbal therapies) you are giving your animal, as well as the amount and schedule of each.
• Tell your veterinarian about any conditions or diseases your animal may have now or has had in the past.
• If your animal has been treated for the same disease or condition in the past, tell your veterinarian about the treatment and how well it did or didn’t work
• Tell your veterinarian and pharmacist about any medication side effects(including skin rashes, lack of appetite, vomiting, diarrhea, itching, and/or hair loss) your animal has developed in the past. Specific precautions to be taken by the person administering the medicinal product vet to animals:
• People with known hypersensitivity to antihistamines should avoid all contact with the veterinary medicinal product.
• Administer the veterinary medicinal product with caution. Wear gloves when handling the veterinary drug.
• In case of accidental self-injection, consult a doctor immediately and show him the package insert or label. Use during pregnancy, lactation or lay:
• Do not use during pregnancy or lactation. Special precautions for the disposal of the veterinary medicinal product no used or, where appropriate, the waste derived from its use:
• Any unused veterinary drug or residues derived from it must be disposed of in accordance with local regulations.
Main incompatibilities:
• In the absence of compatibility studies, this veterinary medicinal product must not
be mixed with other veterinary drugs.

Contraindication:

• Diphenhydramine is contraindicated in dogs who are hyper-sensitive to it or other antihistamines in its class.
• Because of their anticholinergic activity, antihistamines should be used with caution in dogs with angle closure glaucoma, prostatic hypertrophy, pyloroduodenal or bladder neck obstruction, and COPD if mucosal secretion are a problem.

Drug – drug Interactions:

Do not co-administer with barbiturates, CNS depressants and cholinergic agonists.

Adverse Effects:

• The appearance of drowsiness, hypotension, asialia and dryness of the respiratory tract, which can cause coughing.
• More rarely, excitement, motor incoordination, seizures, tachycardia,
• Mydriasis, urinary retention and dysuria.
• In any case, the symptoms are temporary and revert after stopping the medication.
• Dry mouth and trouble urinating (eg, straining) are possible but not common.
• The most common side effect, which is often desirable, is sleepiness. Most animals will become tolerant to this effect with time and will not get as sleepy when given the medication.
• Infrequently, diphenhydramine may cause gastrointestinal distress such as vomiting, decreased appetite, or diarrhea.
• You don’t have to be overly concerned if you see any of these signs unless they are severe, worsen, or continue to be a problem Contact your veterinarian if this happens.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
• Overdose can cause excitement, ataxia, incoordination, seizures, mydriasis, tachycardia, hyperthermia and urinary retention. Treatment will generally be symptomatic.

Withdrawal Periods:

• Not applicable.
• Equidae must be declared as an animal not intended for slaughter for human
consumption.

Storage conditions:

Store at a temperature not exceeding 30°C and used immediately after opening.

Packaging:

Carton Box contains Colorless glass ( Type II ) vials containing 100 ml solution closed with bromobutyl rubber stopper and non-re-usable aluminum closures with an outer label and insert Leaflet.