INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo A.P.L.® Injection 5 000 IU
A.P.L.® Injection 10 000 IU

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

A.P.L.® Injection 5 000 IU
A.P.L.® Injection 10 000 IU
plus Sterile Diluent for A.P.L.®Injection

COMPOSITION:
A.P.L. (
human chorionic gonadotropin (HCG)) is biologically standardised and the potency is declared in terms of the second International Standard for Chorionic Gonadotropin. Each unit represents the specific gonadotropic activity of 0,001279 mg of the standard preparation held by the National Institute for Medical Research (England) on behalf of the World Health Organisation.

When reconstituted with 10 mL of accompanying sterile diluent, the resulting solutions also contain 2,0% Benzyl alcohol as a pr preservative, not more than 0,2% phenol, and the following concentration of (lactose: APL 5 000: 0,9%; APL 10 000:1,8%.

PHARMACOLOGICAL CLASSIFICATION:
Category A, 21.10 Trophic hormones.

PHARMACOLOGICAL ACTION:
Chorionic gonadotropin is a hormone of human pregnancy; it is secreted by the syncytiotrophoblast of foetal placenta as early as 7 days after ovulation, and it is absorbed into the blood in sufficient quantity to sustain luteal function and forestall the next menstrual period. The secretion of LH therefore remains suppressed because of the rising concentrations of oestrogen and progesterone (Lipsett and Ross, 1978).

Peak levels of serum HCG are reached between the eighth and twelfth weeks of gestation. Thereafter, the levels decline reaching a nadir in the second trimester where they remain until parturition.

The changes in the corpus luteum in early pregnancy reflect the intense luteotrophic stimulation provided by the LH-like action of chorionic gonadotropin.

In the pregnant woman HCG is placentotrophic, increasing the output of oestrogens and progestogens from the placenta. An adrenotrophic effect on the foetus has also been demonstrated.

In the male, A.P.L. (chorionic gonadotropin) is given in an attempt to stimulate the interstitial cells of the testes (cells of Leydig) to produce androgen. The response may be considered similar to the effect produced by the interstitial cell-stimulating hormone (ICSH) from the anterior lobe of the pituitary (anterior pituitary-like).

A.P.L. is likely to be of benefit in conditions directly related to insufficient secretion of androgen provided the interstitial cells of the testes are capable of stimulation.

A.P.L. (human chorionic gonadotropin) has no known effect on fat mobilization, appetite or sense of hunger or body fat distribution. HCG has not been demonstrated to be effective adjunctive therapy in the treatment of obesity.

INDICATIONS:
In the female:
1. Infertility - Ovulation Induction:
  A.P.L. is used in the induction of ovulation after the carefully monitored stimulation of follicular maturation with either human menopausal gonadotrophins (HMG) or clomiphene citrate.
In the male:
2. Cryptorchidism not due to anatomic obstruction. A.P.L. may also be used
  (a) as a diagnostic aid to determine the need for surgery;
  (b) pre-operatively, with a view to facilitating the procedure by increasing the size of the testes and the length of the cords.
  (c) Postoperatively as an aid in preventing retraction of the testes.
3. In selected cases of male hypogonadism secondary to pituitary failure (delayed adolescence, hypogonodotropic eunuchoidism).
CONTRA-INDICATIONS:
Precocious puberty, prostatic carcinoma or other androgen dependent neoplasia, prior allergic reaction to chorionic gonadotropin.

Conditions in which fluid retention may be dangerous e.g. asthma, migraine, cardiac or renal disorders.

DOSAGE AND DIRECTIONS FOR USE:
1. Infertility - Ovulation Induction: A.P.L. is administered by intramuscular injection in a dose of 10 000 IU when the desired level of monitored follicular maturation has been achieved. In the case of HMG stimulation A.P.L. is given when the oestradiol levels have reached their optimal pre-ovulatory peak. With clomiphene citrate therapy, A.P.L. is administered when the clinical parameters, especially the cervical mucous score, are considered favourable. This situation is usually reached on the 12th day of a programmed cycle.
2. Cryptorchidism: In most cases, 10 to 12 years would appear to be an appropriate age to start therapy. Depending on the age and size of the patient, A.P.L. may be given intra-muscularly as follows:
  i) 1 000 IU three times weekly, for six to eight weeks, or
  ii) 4 000 IU three times weekly, for two to three weeks.
3. Delayed adolescence: In an attempt to set in motion the normal mechanism of puberty, A.P.L. (chorionic gonadotropin), 4 000 to 5 000 IU may, be administered intra-muscularly three times weekly for six to eight weeks with a rest period of two to three weeks between courses of therapy.
4. Hypogonadotropic eunuchoidism: A.P.L. (chorionic gonadotropin), 4 000 to 5 000 IU may be administered intra-muscularly three times weekly for six to eight weeks with a rest period of two to three weeks between courses of therapy. Therapy is directed to the development of primary and secondary sex characteristics. Best results are obtained in the patient of pubertal age. In the patient of adult age, failure to respond to a therapeutic trial with A.P.L. is usually an indication for substitution therapy with androgen.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Evidence of sexual precociousness is an indication for the immediate withdrawal of treatment. However, therapy on a reduced dosage regimen may be resumed after regression of undue development in those cases in which such therapy is believed warranted.

Development of oedema in males has been reported in a few instances where a high, dosage regimen was being employed. This is usually regarded as a manifestation of salt and water retention attributable to androgen secretion resulting from stimulation of the testicular cells of Leydig. Dosage should be sharply reduced in such cases.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic (see: SIDE-EFFECTS).

IDENTIFICATION:
A.P.L. 5 000 IU: Each package provides one vial containing 5 000 IU chorionic gonadotropin in the dry form of a white amorphous solid and one 10 mL ampoule sterile diluent.

A.P.L. 10 000 IU: Each package provides one vial containing 10 000 IU chorionic gonadotropin in the dry form of e white amorphous solid and one 10 mL ampoule sterile diluent.

PRESENTATION:
A.P.L. 5 000 IU: Each package provides one vial containing 5 000 IU chorionic gonadotropin in dry form, and one 10 mL ampoule sterile diluent which contains 2% Benzyl alcohol, as preservative.

A.P.L. 10 000 IU: Each package provides one vial containing 10 000 IU chorionic gonadotropin in dry form, and one 10 mL ampoule sterile diluent which contains 2% Benzyl alcohol, as preservative.

STORAGE INSTRUCTIONS:
Store in a refrigerator, but do not freeze
After reconstitution, may be stored for 30 days in a refrigerator.
Keep out of reach of children.

REFERENCE NUMBERS:
A.P.L. 5 000 IU - G3008 (Act 101/1965)
A.P.L. 10 000 IU - G3009 (Act 101/1965)
Sterile Diluent for A.P.L. Injection - G3255 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT: AKROMED PRODUCTS
Electron Avenue, ISANDO, 1600
Trademark and product under licence from
WYETH-AYERST LABORATORIES, U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 December 1974
        24200 EB311
        Davbar Dbn.

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