TachoSil Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per cm² Human fibrinogen 5.5 mg, human thrombin 2 IU

Indications/Uses

Adjunct to haemostasis during surgery when control of bleeding by standard surgical techniques is ineffective or impractical.

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Dosage/Direction for Use

Individualised dosage. Usual dose: 1-2 sponges (9.5 cm x 4.8 cm). Smaller wound (eg, minimal invasive surgery) 4.8 cm x 4.8 cm or 3 cm x 2.5 cm.

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Overdosage

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Contraindications

Hypersensitivity. Do not apply intravascularly.

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Special Precautions

Immediately discontinue use if hypersensitivity reactions including urticaria, chest tightness, wheezing, hypotension & anaphylaxis occurs. For topical use only. Possible thromboembolic complications if applied intravascularly. Use in neurosurgery after recent RT or in GI anastomotic surgery. Not to be used for severe or brisk arterial bleeding; procedures involving renal pelvis or ureter; closure of skin incisions. Ensure adequate cleaning of tissue areas outside the desired application area before administration to prevent development of tissue adhesions at undesired sites. May potentiate existing infection; do not leave in an infected or contaminated space. Possibility of transmitting infective agents. Instruct patients to consult their clinician if symptoms of B19 virus infection appear (eg, fever, drowsiness, chills & runny nose followed about 2 wk later by rash & joint pain). Pregnancy & lactation. Not recommended for use in childn <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Atrial fibrillation, pyrexia, pleural effusion, pneumonia, nausea, pneumothorax, constipation, resp failure, tachyarrhythmia, HTN, wound infection, atelectasis, post-procedural haemorrhage, anemia, pain, pruritus, hypotension, hyperglycemia, sleep disorder, haemorrhagic anaemia, cystitis, dyspnoea, insomnia, MI, procedural site reactions, bronchopleural fistula, flatulence, UTI, vocal cord paralysis, increased Hb.

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Drug Interactions

May be denatured after exposure to soln containing alcohol, iodine or heavy metals (eg, antiseptic soln).

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view TachoSil detailed prescribing information

Storage

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Description

View TachoSil description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Haemostatics

ATC Classification

B02BC30 - combinations ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.

Regulatory Classification

POM

Presentation/Packing

Form

TachoSil sponge

Packing/Price

(3 cm x 2.5 cm) 1's; (9.5 cm x 4.8 cm) 1's

TachoSil

Manufacturer:

Corza Medical

Distributor:

Zuellig Pharma

Marketer:

Wellesta