Растворы антикоагулянтные для сбора компонентов крови: раствор антикоагулянтный Цитрат натрия 4%, 250 мл (420С)

מדינה: בלארוס

שפה: רוסית

מקור: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

זמין מ:

Haemonetics Corporation, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

סיווג:

изделия медицинского назначения

תוצרת:

Haemonetics Corporation

תאריך אישור:

2018-05-31

מאפייני מוצר

HAEMONETICS CORPORATION
400 Wood Road, Braintree, Massachusetts 02184, USA
Visit us on the Web at WWW.HAEMONETICS.COM
127784-00 AA
: 2020-03
ACD-A
ACID CITRATE DEXTROSE - FORMULA A
(ACD-A) - ANTICOAGULANT SOLUTION
_SOLUTIONS FOR BLOOD COMPONENT COLLECTION BY APHERESIS_
0426C-NC, 0427C-NC, 0427K-00
ENGLISH
ACID CITRATE DEXTROSE - FORMULA A (ACD·A) - ANTICOAGULANT SOLUTION
USER INFORMATION AND LNSTRUCTIONS FOR USE LEAFLET
Please read carefully all the following instructions to use the
solutions in total security.
I. INFORMATION ABOUT THE PRODUCT
1. PRODUCT NAME
ACD-A (Acid Citrate Dextrose Solution - Formula A) Anticoagulant
Solution.
2. PRODUCT FORMULA
Each 1 litre of solution contains:
Sodium Citrate Ph. Eur.
22.0 g (2.2% weight in volume)
Citric Acid, monohydrate Ph. Eur.
8.0 g (0.8% weight in volume as monohydrate)
Glucose, monohydrate Ph. Eur.
24.5 g (2.45% weight in volume as monohydrate)
Water for Injections Ph. Eur. to
1000 ml
3. PHARMACEUTICAL FORM OF THE PRODUCT
ACD-A Anticoagulant Solution is a sterile, pyrogen-free, clear,
colourless anticoagulant solution in
printed PVC bags, each with a laminated polypropylene overwrap.
Product is presented in 500 ml, or 750 ml volumes.
4. PHARMACO-THERAPEUTIC GROUP
Whole Blood Anticoagulant Solution.
I
I. THERAPEUTIC INDICATIONS
ACD-A Anticoagulant Solution is for use only for the anticoagulation
of whole blood as part of automated
apheresis procedures.
III. IMPORTANT INFORMATION
1. CONTRAINDICATIONS
None known.
2. PRECAUTIONS FOR USE
- Do not administer directly as an intravenous solution.
- Do not use unless solution is clear.
- Do not use if unit is damaged.
- Discard any unused product.
- Do not re-use the solution bag.
3. INTERACTIONS WITH MEDICAMENTS AND OTHER FORMS OF INTERACTION
Medicaments should not be added to ACD-A Anticoagulant Solution.
4. SPECIAL WARNINGS
- CAUTION: This device contains di(2-ethylhexyl) phthalate (DEHP).
Precautions should be taken to limit long-term exposure to DEHP in
certain groups of patients who,
based on animal data, may be at r