Adco-Blood Primary Container With Citrate Phosphate Glucose
Clinical Summary
Quick overview from the medicine insert
Indication
Blood preservative for storage of collected blood up to 28 days.
Dosage (summary)
Collect 450 ml of blood using 63 ml anticoagulant solution.
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established.
Contraindications
- None
Counselling Points
- Use aseptic technique during blood collection.
- Mix blood with anticoagulant during collection.
Serious warnings
- Not intended for administration in its original form.
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
ADCO-BLOOD PRIMARY CONTAINER WITH CITRATE PHOSPHATE GLUCOSE ANTICOAGULANT solution is indicated as a blood preservative in instances where storage of collected blood is required for periods up to 28 days. The dilution effect that ADCO-BLOOD SECONDARY CONTAINER WITH SALINE ADENINE GLUCOSE MANNITOL (SAG-M) has on the concentrated red cells is important for rapid administration of red blood cells during medical emergencies and in surgical procedures.
4.2 Posology and method of administration
Posology
Blood is collected into a triple blood pack unit, ADCO-BLOOD PRIMARY CONTAINER WITH CITRATE PHOSPHATE GLUCOSE ANTICOAGULANT containing 63 ml of solution, for the collection of 450 ml of blood. Attached to the primary pack is an ADCO-BLOOD SECONDARY CONTAINER WITH SALINE ADENINE GLUCOSE MANNITOL (SAG-M) containing 100 ml of solution.
Method of administration
A. General instructions for use
1. Use aseptic technique.
2. Apply a blood pressure cuff or place a tourniquet.
3. Disinfect site of venepuncture.
4. Tie tourniquet or inflate pressure cuff to 60 mm Hg.
5. Clamp donor tube, remove needle cover and perform venepuncture.
6. Release clamp from donor tube to permit flow of blood.
7. Mix blood and anticoagulant at several intervals during collection and immediately after collection.
8. Collect the quantity of blood within the limits indicated on the pack label.
9. Collect pilot samples using the sampling pouch and the appropriate sampling tubes and clamps, as described below.
10. Remove tourniquet or release pressure in cuff and withdraw needle.
B. Blood collection
1. Close the white clamp to the primary collection pack.
2. To remove the needle cap, twist to break the tamper-proof seal between the needle and its cap and remove it by sliding it down the axis of the needle. Perform the venepuncture.
3. Break the cannula next to the sampling pouch by bending the rigid part back and forth 3 times at 90 u00b0. Allow the sampling pouch to fill to the desired level.
4. Close the blue clamp to the sampling pouch and immediately open the white clamp to the primary collection pack.
5. The closed blue clamp, a permanent closure device, will ensure the sampling line is sealed.
6. Proceed then immediately to blood sampling by opening the holder (if a cap is present), then by collecting samples in vacuum tubes with stopper oriented upwards.
7. Ensure regular agitation during the course of collection, in order to allow mixing of blood with the anticoagulant solution.
8. Collect the quantity of blood within the limits indicated on the pack label.
9. When the collection is completed, seal the donation tube by closing the white clamp.
10. Loosen the tourniquet or deflate the pressure cuff.
11. If necessary, strip the donor tubing towards the collection pack, mix and leave the tubing filled with new blood.
12. Store the whole blood unit according to appropriate regulations.
C. Instructions for blood component preparation
1. Follow the stated instructions for blood collection and sampling (see A. General instructions for use and B. Blood collection).
2. The blood component preparation should be performed within 24 hours after blood collection.
3. Blood component preparation for the triple blood pack to be performed as required by the blood transfusion service.
4.3 Contraindications
None
4.4 Special warnings and precautions for use
This solution is not intended for administration in its original form.
4.5 Interaction with other medicines and other forms of interaction
None
4.6 Fertility, pregnancy, and lactation
Safety in pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
a. Summary of the safety profile
The safety of infusions of more than 5 units of ADCO-BLOOD SECONDARY CONTAINER WITH SALINE ADENINE GLUCOSE MANNITOL (SAG-M) has not been established. Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. For reporting of side effects directly to the holder of the certificate of registration, contact +27 11 635 0134 or email [email protected].
4.9 Overdose
None