Thông tin thuốc gốc
Chỉ định và Liều dùng
Hypovolaemic shock
Adult: As 4% succinylated gelatin (modified fluid gelatin): Volume and infusion rate depends on the condition of the patient (e.g. amount of blood loss, blood pressure). Usual dose: Initially, 500-1,000 mL; higher doses may be given in severe cases. Administer the initial 20-30 mL slowly with careful observation for early detection of anaphylactic reactions. In emergency cases: 500 mL infused over 5-10 minutes may be given until signs of hypovolaemia are resolved. Doses are administered via infusion.

Adult: Adjunct to haemostasis in surgical procedures (except ophthalmic) when control of bleeding by pressure, ligature or other conventional procedures is ineffective or impractical: As absorbable gelatin sponge: Cut the sponge to the desired size and apply directly onto the bleeding site (either dry or saturated with sterile isotonic NaCl solution). Additional applications may be made if the 1st application does not control the bleeding. As absorbable gelatin powder: Apply the prepared paste onto the bleeding surface. Remove excess when the bleeding stops. Use the minimum amount needed to produce haemostasis; remove any excess once haemostasis is achieved.
Hướng dẫn pha thuốc
Topical: As absorbable gelatin powder: To prepare a putty-like paste, open the envelope and pour the contents (1 g) carefully into a sterile beaker. Add a total of approx 3-4 mL of sterile isotonic NaCl solution to the powder, then mix well.
Chống chỉ định
IV: Hypersensitivity to galactose-α-1,3-galactose (alpha-Gal) or known allergy to red meat (mammal meat) and offal; hypervolaemia, hyperhydration. Topical: Hypersensitivity to porcine collagen. Primary treatment of coagulation disorders, closure of skin incisions, presence of infection, control of postpartum bleeding or menorrhagia. Application into intravascular compartments.
Thận trọng
IV: Patient with blood coagulation disorders, risk factors for circulatory overload (e.g. cardiac disease, CHF, hypertension, pulmonary oedema), oedema with salt or water retention, hypernatraemia, hyperkalaemia, history of allergic diseases (e.g. asthma); renal failure with oliguria or anuria. Topical: Application into contaminated areas of the body. Not intended as a substitute for surgical techniques and proper application of ligatures or conventional procedures for haemostasis. Safety and efficacy with topical thrombin have not been evaluated in studies; if concurrent use is necessary based on the doctor’s judgment, refer to thrombin detailed product information. Renal and hepatic impairment. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: IV: Electrolyte imbalance, circulatory overload, dilution of blood coagulation factors.
Cardiac disorders: Tachycardia.
General disorders and administration site conditions: Chills, pyrexia (IV); asthenia, foreign body reactions, encapsulation of fluid, and haematoma at the application site (topical).
Infections and infestations: Wound infection (topical).
Respiratory, thoracic and mediastinal disorders: Rarely, dyspnoea, hypoxia, wheezing (IV).
Skin and subcutaneous tissue disorders: Rarely, sweating, urticarial reactions (IV); pruritus, rash (topical).
Vascular disorders: Rarely, hypertension or hypotension (IV).
Potentially Fatal: Rarely, anaphylactic/anaphylactoid reactions.
Chỉ số theo dõi
IV: Monitor serum electrolytes, fluid balance, blood pressure, Hb, haematocrit (which must not fall <25%), coagulation parameters, renal and hepatic functions, and haemodynamic status of the patient. Closely assess for hypersensitivity reactions.
Quá liều
IV: Symptoms: Hypervolaemia, electrolyte imbalance, circulatory overload (manifested by dyspnoea, headache, jugular vein congestion) with significant fall in haematocrit and plasma proteins. These symptoms may lead to impairment of heart and lung function (e.g. pulmonary oedema). Management: Symptomatic treatment with monitoring of electrolytes. Administer a rapid-acting diuretic in case of circulatory overload.
Tương tác
May increase the risk of paradoxical hypotensive reactions with ACE inhibitors (IV).
Ảnh hưởng đến kết quả xét nghiệm
IV: May increase the blood sedimentation rate, urine specific gravity, and non-specific protein assays (e.g. by biuret method).
Tác dụng
Description: Gelatin acts as a plasma volume substitute as a succinylated gelatin preparation. Succinylation of gelatin molecule results in a negatively charged molecule with consequent spatial expansion. Absorbable gelatin is used as a haemostatic in surgical procedures. Its mode of action is not fully understood, but it appears to arrest bleeding by forming an artificial clot and producing a mechanical matrix that facilitates clotting.
Duration: 3-4 hours (IV).
Absorption: Topical: May be completely absorbed in the application site (when used in appropriate amounts).
Excretion: IV: Mainly via urine (75%); faeces (small amounts). Elimination half-life: Approx 4 hours.
Bảo quản
Solution for infusion: Store below 25°C. Do not refrigerate or freeze. Sponge/powder: Store between 15-30°C.
Phân loại MIMS
Thuốc cầm máu
Phân loại ATC
B05AA06 - gelatin agents ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
B02BC01 - absorbable gelatin sponge ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.
Tài liệu tham khảo
Anon. Gelatin (Absorbable). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 20/01/2021.

Anon. Gelatin (Succinylated). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 20/01/2021.

Buckingham R (ed). Gelatin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 20/01/2021.

Gelfoam Sterile Sponge (Pfizer, Inc.). MIMS Philippines. Accessed 20/01/2021.

Gelofusine Ecobag (B. Braun Melsungen AG). MHRA. Accessed 20/01/2021.

Isoplex 4% Solution for Infusion (Beacon Pharmaceuticals Limited). MHRA. Accessed 20/01/2021.

Joint Formulary Committee. Gelatin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 20/01/2021.

Surgifoam Sterile Sponge (Ethicon US, LLC). U.S. FDA. Accessed 20/01/2021.

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