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

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CALCIPARINE
Injection

COMPOSITION:
Ampoule/ pre-filled syringe containing 25 000 I.U. calcium heparin per mL:
0,2 mL pre-filled syringe contains 5 000 I.U. calcium heparin.
0,3 mL pre-filled syringe contains 7 500 I.U. calcium heparin.
0,5 mL pre-filled syringe contains 12 500 I.U. calcium heparin.
0,8 mL pre-filled syringe contains 20 000 I.U. calcium heparin.

PHARMACOLOGICAL CLASSIFICATION:
A.8.2 Medicines acting on blood and haemopoietic system –Anti-coagulants.

PHARMACOLOGICAL ACTION:
Anti-coagulant. Calcium and sodium heparin both produce identical anti-coagulant effects. Calcium heparin does not act as a strong chelator of calcium ions.

INDICATIONS:

i)	Prevention of post-operative deep-vein thrombosis.
ii)	Prevention and treatment of thrombo-embolic phenomena.

CONTRA-INDICATIONS:
Bleeding diathesis: haemorrhagic organic lesions.
Heparin is contra-indicated in patients with haemorrhagic diseases or acute or potential bleeding sites, including haemophilia, post-operative oozing of blood, subacute bacterial endocarditis, gastric or duodenal ulcer, threatened abortion, advanced renal or hepatic disease, jaundice or severe hypertension.

DOSAGE AND DIRECTIONS FOR USE:
CALCIPARINE IS TO BE INJECTED SUBCUTANEOUSLY AND NOT BY THE INTRAVENOUS ROUTE.

i)	Prevention of post-operative deep-vein thrombosis: 0,2 mL calciparine 2 hours pre-operatively and 0,2 mL eight-hourly thereafter for at least 7 days
ii)	Treatment of thrombo-embolism:
	1st injection: Standard test dose is determined according to the weight of the individual (0,1 mL for 10 kg body weight).
	Six hours later: Take partial-thromboplastin time (P.T.T.) in citrated plasma in order to check whether the test dose is suitable (P.T.T. should be 1,5 to 2,5 times that of control).
	2nd injection: (12 hours after the first): Test dose, modified or unmodified, according to the P.T.T. at the sixth hour.
	Therafter, one injection every 12 hours, the dose used being that arrived at for the 2nd injection. The P.T.T. should be repeated 6 hours after the 6th or 7th injection to adjust the dose if necessary. In long-term therapy, this test should be repeated once a week. The aim is to maintain an effective state of hypocoagulability.

The treatment may be continued for as long as is indicated for the individual treatment. Treatment may be terminated when a therapeutic hypocoagulability is reached (P.T.T.) being 1,5 to 2,5 times more than that of the control) with very reduced doses, which indicates that thrombophilia is attenuated.

Injection Technique:
Using the syringe and needle included in the box, the injection should be carried out in the subcutaneous tissue over the iliac crest, alternately to the left and right. The needle should be inserted completely, perpendicularly, not tangentially, in a skin fold pinched up between the operators’s thumb and forefinger. Do not inject the the liquid if the insertion of the needle causes a sharp pain. This indicates that the needle has entered a blood vessel. In such a case, withdraw the needle and carry out the injection in the opposite side.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Complications of calcium heparinate are bleeding in various sites and febrile or allergic reactions. Transient alopecia may occur. Thrombocytopenia and osteoporosis with spontaneous fractures have been reported.
Special care should be taken when treating elderly patients and pregnant women.
The anticoagulant action of heparin may be enhanced by acetylsalicylic acid, dipyridamole, phenylbutazone, indomethacin, sulfinpyrazone, probenecid, dextrans, ethacrynic acid and cytostatic medicines; and may be diminished by antihistamines, digitalis, tetracyclines, nicotine and ascorbic acid.
Heparin suppresses the following drugs in the plasma protein bond: phenytoin, quinidine, propranolol, benzodiazepines and bilirubin. Heparin binds to basic drugs such as quinidine, thus reducing its effect.
CALCIPARINE IS FOR SUBCUTANEOUS INJECTION ONLY AND THE INJECTION TECHNIQUE DESCRIBED MUST BE CAREFULLY OBSERVED TO AVOID COMPLICATIONS AT THE INJECTION SITE.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Slight epistaxis, occasional red cells in the urine, and bruising are signs of overdosage. Withdraw the medicine.
The antidote is protamine sulphate by slow intravenous injection, usually at a rate of 0,5 mL/minute. The amount of protamine so required is based on 1 mg protamine sulphate for each 100 units of heparin to be neutralized. If protamine sulphate is given more than 30 minutes after the heparin, the protamine dose may be reduced to about one half. Not more than 50 mg protamine sulphate should be injected for any one dose. Further doses may be required.

IDENTIFICATION:
1 mL ampoules containing 0,5 mL (12 500 I.U.) and 0,8 mL (20 000 I.U.) as well as sterile, pre-filled syringes containing 0,2 mL (5 000 I.U.) and 0.3 mL (7500 I.U.) of a clear colourless to slightly yellow solution of calcium heparin.

PRESENTATION:
Boxes of 2 and 10 ampoules 0,5 mL (12 500 I.U.) and 0,8 mL (20 000 I.U.) with one sterile syringe per ampoule.
Boxes of 10 sterile pre-filled syringes of 0,2 mL (5 000 I.U.), 0.3 mL (7500 I.U.), 0,5 mL (12 500 I.U.) and 0,8 mL (20 000 I.U.).

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
0,2 mL –H/8.2/289
0,3 mL –H/8.2/199
0,5 mL –H/8.2/290
0,8 mL –H/8.2/291

NAME AND ADDRESS OF THE APPLICANT:
The Premier Pharmaceutical Co, Ltd.
Adcock Ingram Park
17 Harrison Avenue, Bryanston Ext. 77
Private bag X69, Bryanston, 2021.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
06/03/1989

New addition to this site: April 2004
Source: Pharmaceutical Industry
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