BROADCHEM CORPORATION

CANGLOB P

0.4 ml per 1 kg of weight i. v., i. m. or s. c.

Product characteristics
The product CANGLOB P consists of hyperimmune heterogeneous purified immunoglobulins against parvovirosis of dogs.

Dosage form
Injections

Qualitative and quantitative composition
Each one ml of the product contains:

Active ingredients:
immunoglobulinum anti parvovirosis canis NLT 1024 HIU;

Inactive ingredients:
thiomersalum NMT 0.1 mg;
solutio PBS ad 1 ml.

Animal species to be treated with the product
Dogs and canine animals

Dosage
The therapeutic dose is 0.4 ml of the product per 1 kg of body weight of the animal being treated given daily until an improvement of the health status. The product should be used in ill animals. The prophylactic dose is 0.4 ml of the product per 1 kg of body weight of the animal given at fi ve-day intervals. It may be used when the danger of disease is imminent. The highest daily dose is 0.4 ml of the product per 1 kg of body weight of the animal, and it may be used both for therapeutic and prophylactic purposes.

Overdosage
The product is safe after administration of a doubled dose per 1 kg of live weight.

Route of administration
The product may be administered i. v., i. m. or s. c.

Indications
The product is designed for the treatment of parvovirosis in dogs and on an immediate prophylaxis of animals in cases when the causative agent of the disease has not been explicitly determined. Specifi c antibodies facilitate to inhibit an incidence of this disease or, if already running, to alleviate its course. An early administration is important for successful treatment.

Contraindications
Generally, the administration of this product represents an overall immunobiological stress for the animal. Repeated administration of the product may result in sensitization of animals and in
a sporadic incidence of anaphylactic reactions. The product is contraindicated particularly on its prophylactic use in sensitized animals or on an onset of allergic and anaphylactic reactions when used repeatedly. Contraindication depends on a decision made by a veterinary surgeon who should weigh the severity of the course of the disease against a potential risk of treatment with this product.

Adverse drug reactions
Infrequently, the administration of this product may induce an allergic or anaphylactic reaction, which is true particularly on repeated administration. The general reactions of the organism may refl ect in sub-febrile elevation of temperature, transient inappetence and general weakness.

Interactions
No interactions with other medicinal products are known. A mere supply of specifi c antibodies is
achieved by administration of the product. As far as known, an administration of other medicines exerts no effects on passive immunization. Adjuvant therapy must be used in case of an incidence of adverse drug reactions. In the course of treatment and for a period of 7 days after its termination, active immunization against diseases for which the product is designed is not advisable.

Pregnancy and lactation
Besides general and infrequent reactions, no risks of passive immunization of pregnant females and females after parturition are known. Despite this fact, based on general knowledge, the product should not be administered at the late stage of pregnancy and closely after parturition. Immunization of pregnant females may be implemented at early and medium stages of pregnancy. The passive immunization of mothers has not an essential infl uence on protection of their youngsters in the form of the colostral immunity. Specifi c antibodies obtained by the passive immunization are not actively passed to youngsters with colostrum. These antibodies have no undesirable effects on youngsters.

Withdrawal periods
None.

How supplied
Type of package:
Glass or plastic medicinal bottles are closed with a rubber stopper and an aluminum torque collar, provided with a label and placed in a carton box together with a package information leafl et and a label to be stuck up into a vaccination card.

Package Availability:
1 x 6 ml, i.e. 6 ml of the product in 1 medicinal bottle sized 7 ml;

Shelf-life
The product must be completely used until expiration of the shelf-life indicated on the label of each medicinal bottle, i.e. within 18 months from the date of manufacture. The product must not be used after expiration of the shelf-life. After it has been opened, the contents of the medicinal bottle must be used within 10 hours.

Storage
In a dry and dark place at temperatures between 2 and 8 °C

Special precautions
The administration of heterogeneous immunoglobulins induces passive immunity for a period of NMT 7 days. It is not recommended to vaccinate with live vaccines during this period. The route of administration and the length of treatment or prophylactic protection depend on a decision made by a veterinary surgeon. Adverse reactions may be sometimes prevented by a decision regarding treatment or prophylactic use of the product.