NAM PHUC THINH TRADING CO., LTD

GALAPAN

Composition: Each ml solution contains: D-cloprostenol as sodium D-cloprostenol    0.075 mg; excipient q.s 1 ml.

Pharmaceutical form: Injectable solution

Properties:

-GALAPAN is a drug based on clockwise Cloprostenol.

-Dextrorotatory cloprostenol is a synthetic analogue of F2α prostaglandin.

-The dextrorotatory enantiomer is Cloprostenol’s biologically active luteolytic component.

-GALAPAN is approximately 3.5 times more powerful than similar medicinal products based on racemic Cloprostenol. It can thus be used proportionally at a lower dose level. GALAPAN is more effective and better tolerated than racemic Cloprostenol.

-GALAPAN induces a drop in the number of luteinizing hormone (LH) receptors in the ovaries during the luteinizing phase of the oestrus cycle, which leads to a fast regression of the corpus luteum and a decrease in progesterone levels. The front part of the pituitary gland increases the levels of follicle-stimulating hormone (FSH). This allows the maturing of new follicles, the onset of oestrus and ovulation.

Target species: Bovine (Cows), pig (reproductive sows) and horses (mares not intended for human consumption).

Indications for use (specifying the target species and type of treatment):

The drug GALAPAN is indicated in cows, pigs and mares for:

- Inducing oestrus and synchronization in cows;

- Inducing labor in cows, sows and mares;

- Inducing oestrus in mares;

- Ovary dysfunction in the presence of the corpus luteum: postpartum anoestrus, silent oestrus, irregular cycle and non-ovulating cycle, persistent corpus luteum, lutein cysts;

- Endometritis, pyometra;

- Interruption of pregnancy (during the first half), foetal mummification;

- Post-puerperium metropathy, delayed uterine involution;

- Combined follicular cyst therapy (10-14 days after the administration of GnRH or HCG).

Amounts to be administered and administration route:

GALAPAN is administered exclusively via the intramuscular route.

Bovine (cows): The recommended dose is 0.150 mg D-cloprostenol, equivalent to 2 ml.

• Induction of oestrus (also in cows with weak or silent oestrus): Aminister the product after determining the presence of corpus luteum (day 6 – 8 of the cycle). Oestrus is generally observed in 48 – 60 hours. Inseminate 72 – 96 hours after the previous treatment.
• Induction of labor: Administer the product after day 270 of pregnancy. Labor should occur 30 – 60 hours after the treatment.
• Oestrus synchronization: Administer the product twice (with an interval of 11 days). Inseminate artificially 72 and 96 hours after the second injection.
• Ovary dysfunction: Having determined the presence of the corpus luteum, administer the product and inseminate in the first oestrus following treatment. If no oestrus is observed, carry out another gynaecological examination and repeat the injection 11 days after the first treatment. Inseminate is performed 72 – 96 hours after the treatment.
• Endometritis or pyometra: Administer 1 dose of the product. Repeat the treatment 10 days later if necessary. Inseminate 72 – 96 hours after treatment.
• Interruption of pregnancy: Administer the product during the first half of pregnancy.
• Foetal mummification: Administer 1 dose of the product. The foetus will be expelled after 3 or 4 days.
• Post-puerperium metropathy; delayed uterine involution: Administer 1 dose of the product and, if indicated, repeat the treatment once or twice at a dose of 1 ml (24 hours later).
• Follicular cyst combined therapy: Administer the product 10-14 days after the administration of GnRH or HCG, once a positive response is observed from the ovary.

Horses (mares not intended for human consumption): The recommended dose is 0.075 mg D-cloprostenol/animal, equivalent to 1 ml/animal. Repeat if necessary according to indications.

• Induction of oestrus: Administer the product, preferably if the presence of the corpus luteum is observed (progesterone determination).
• Induction of labor: The product is administered after day 320 of pregnancy. Labour usually occurs after several hours.
• Insemination plan: Administer the product twice (with an interval of 14 days). Inseminate on days 19 and 21 after the first treatment, even in the absence of external signs of oestrus.
• Interruption of prolonged oestrus: Administer the product to induce oestrus, which occurs within an interval of 2 to 8 days following treatment and ovulation, 8-10 days following treatment.
• Interruption of false pregnancy: Administer the product in order to obtain normal ovary function.
• Anoestrus during lactation: Administer the product 20-22 days after labour, after verifying cyclic activity. You will thus obtain oestrus and ovulation.
• Premature foetal death: Administer the product, preferably after confirming the presence of corpus luteum (progesterone determination). Inseminate at the beginning of oestrus.

Pigs (reproductive sows): The recommended dose is 0.075 mg D-cloprostenol/animal, equivalent to 1 ml/animal.

• Induction of labour: Administer the product after day 112 of pregnancy. In about 70% of cases, labor takes place 19 – 30 hours after the treatment.

Contraindication: Avoid treatment of pregnancy animals unless intending to cause abortion or induce labor.

Adverse reactions (frequency and seriousness): No adverse reactions have been observed at dose 10 times greater than the therapeutic dose in cows and sows. In mares, moderate perspiration and soft faeces were detected when administered three times the therapeutic dose.

Use during pregnancy and lactation: Use on pregnant animals causes abortion.

Interaction with other medicinal products and other forms of interaction: Do not use in animals undergoing treatment with non-steroid anti-inflammatory drugs, since it inhibits endogenous prostaglandin synthesis. The activity of other oxytocic agents may increase following cloprostenol administration.

Overdose (symptoms, emergency procedures, antidotes): GALAPAN is well tolerated at doses 10 times greater than the therapeutic dose in cows and sows. In mares, moderate perspiration and soft faeces were detected when administered three times the therapeutic dose.  

Special warnings for each target species: GALAPAN administration is not advised in mares suffering from serious respiratory and/or gastrointestinal diseases.

Withdrawal period:

- Cows: Meat: 0 day; milk: 0 hour.

- Sows: Meat: 1 day.

- Mares: Do not administer to mares whose meat is intended for human consumption.

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

- GALAPAN can be absorbed by the skin and may cause bronchospasm and abortion, as all F2α prostaglandins.

- The product must be handled with care to avoid ACCIDENTAL SELF-INJECTION OR CONTACT WITH SKIN.

- Women of childbearing age, asthmatic people and people with bronchial problems or other types of respiratory problems must avoid contact, or use disposable plastic gloves during product administration.

- Contact a physician immediately if there were respiratory distress due to accidental inhaling or inoculation.

- In the event of accidental contact with the skin, washout immediately with water and soap.

Storage conditions: Not required.

Presentations: Containers of 2, 10, 20 ml.

Shelf-life: 2 years from the manufacturing date; 28 days from the first opening.

FOR VETERINARY USE ONLY

Keep out of the reach of children

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona, Spain