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1. Name Of The Medicinal Product

Hedex or Paracetamol Tablets

2. Qualitative And Quantitative Composition

Each tablet contains Paracetamol Ph Eur 500.0 mg

3. Pharmaceutical Form

White capsule-shaped tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Hedex is a mild analgesic and antipyretic. The tablets are recommended for headaches, including migraine and tension headaches, backache, rheumatic and muscle pain, period pains, nerve pains, toothache and for relieving the fever, aches and pains of colds and flu.

4.2 Posology And Method Of Administration

Adults (including the elderly)

2 tablets up to 4 times a day.

Children

6-12 years: ? - 1 tablet three or four times daily as required. Not suitable for children under 6. Children should not be given Hedex tablets for more than 3 days without consulting a doctor.

These doses should not be repeated more frequently than every 4 hours and not more than 4 doses should be given in any 24 hour period.

Hedex is for oral administration.

4.3 Contraindications

Hypersensitivity to paracetamol or any of the other constituents.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the stated dose.

Patients should be advised to consult their doctor if their headaches become persistent.

Patients should be advised not to take other para

1. Name Of The Medicinal Product

Boots Haemorrhoid Ointment or Haemorrhoid Relief Ointment

2. Qualitative And Quantitative Composition

Active ingredients

% w/w

Specification

Lidocaine

0.6

Ph Eur

Zinc oxide

6.6

Ph Eur

3. Pharmaceutical Form

Rectal ointment.

4. Clinical Particulars

4.1 Therapeutic Indications

This product is indicated for the relief of pain and discomfort of haemorrhoids and pruritis ani.

4.2 Posology And Method Of Administration

HAEMORRHOIDS

Adults, children over 12 years and elderly: This product should be applied night and morning and after each bowel movement. Repeat as required.

EXTERNAL PILES

Moisten cotton wool with warm water and gently cleanse the sore area. Carefully dry with fresh cotton wool and apply approximately 1 inch (2.5 cm) of this product

1. Name Of The Medicinal Product

HALDOL Tablets 5 mg

HALDOL Tablets 10 mg

HALDOL 2 mg/ml

2. Qualitative And Quantitative Composition

Haloperidol 5 mg

Haloperidol 10 mg

Haloperidol 2mg/ml

3. Pharmaceutical Form

Tablets.

Oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

Adults:

• Schizophrenia: treatment of symptoms and prevention of relapse

• Other psychoses: especially paranoid

• Mania and hypomania

• Mental or behavioural problems such as aggression, hyperactivity and self mutilation in the mentally retarded and in patients with organic brain damage

• As an adjunct to short term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour

• Intractable hiccup

• Restlessness and agitation in the elderly

• Gilles de la Tourette syndrome and severe tics.

Children:

• Childhood behavioural disorders, especially when associated with hyperactivity and aggression

• Gilles de la Tourette syndrome

• Childhood schizophrenia.

4.2 Posology And Method Of Administration

For oral administration.

Since the oral solution is not intended for administration in multiples of 5 ml, the quantities given are expressed per ml.

Dosage for all indications should be individually determined and is best initiated and titrated under close clinical supervision. To determine the initial dose, consideration should be given to the patient's age, s

1. Name Of The Medicinal Product

Heparin sodium 10 IU/ml I.V. flush solution

2. Qualitative And Quantitative Composition

Heparin Sodium Ph. Eur. 10 IU/ml

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

To maintain the patency of in-dwelling intravenous lines. It is not recommended for therapeutic use.

4.2 Posology And Method Of Administration

For injection into the catheter/cannula.

For routine use, 1

4.3 Contraindications

Known hypersensitivity to constituents.

Current or history of heparin-induced thrombocytopenia.

4.4 Special Warnings And Precautions For Use

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving regular and repeated use of heparin flush solutions for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

Heparin induced thrombocytopenia and heparin induced thrombocytopenia with thrombosis can occur up to several weeks after discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT and HITT.

Heparin Sodium 10 IU/ml i.v. flush solution should be used with caution in patients with hypersensitivity to low molecular weight heparin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For incompatibilities with other medicinal products see Section 6.2.

When an indwelling device is used for repeated withdrawal of blood samples for laboratory analyses and th

1. Name Of The Medicinal Product

Haemate P 500 and 1000 Powder and solvent for solution for injection or infusion

2. Qualitative And Quantitative Composition

Haemate P 500 IU

Haemate P 500 is presented as a powder and solvent for solution for injection or infusion containing nominally 1200 International Units (IU) human plasma-derived von Willebrand Factor-ristocetin co-factor activity (VWF:RCo) and 500 IU human coagulation factor VIII activity (FVIII:C)per vial.

von Willebrand Factor

Haemate P 500 contains approximately 120 IU/ml (1200 IU/10ml) human plasma-derived VWF:RCo when reconstituted with 10 ml water for injections.

Factor VIII

Haemate P 500 contains approximately 50 IU/ml (500 IU/10ml) human plasma-derived coagulation Factor VIII:C when reconstituted with 10 ml water for injections.

Haemate P 1000 IU

Haemate P 1000 is presented as a powder and solvent for solution for injection or infusion containing nominally 2400 International Units (IU) human plasma-derived von Willebrand Factor-ristocetin co-factor activity (VWF:RCo) and 1000 IU human coagulation factor VIII activity (FVIII:C) per vial.

von Willebrand Factor

Haemate P 1000 contains approximately 160 IU/ml (2400 IU/15ml) human plasma-derived VWF:RCo when reconstituted with 15 ml water for injections.

Factor VIII

Haemate P 1000 contains approximately 66.6 IU/ml (1000 IU/15ml) human plasma-derived coagulation Factor VIII:C when reconstituted with 15 ml water for injections.

The specific activity of Haemat

1. Name Of The Medicinal Product

Human Varicella-Zoster Immunoglobulin 250 mg solution for injection

2. Qualitative And Quantitative Composition

Human Varicella-Zoster Immunoglobulin Ph.Eur. contains human protein, 40-180 g/L of which at least 95% is IgG. The concentration of specific IgG to Varicella Zoster is at least 100 IU/mL in nominal 250 mg vials. The correct volume to give 250 mg is overprinted on the label.

This product is prepared from plasma from screened donors. Donors are selected from the USA.

For excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis against varicella-zoster virus (VZV) infection in at risk patients exposed to varicella (chickenpox) or herpes zoster:

1. pregnant women with negative VZV immune status especially up to early in the third trimester

2. neonates whose mothers develop varicella infection within 7 days before and 7 days after delivery

3. neonates whose mothers have no history of varicella and/or a negative immune status

4. premature infants <28 weeks of gestation or newborns with low birth weight

5. adults and children with no history of varicella and/or a negative immune status, receiving immunosuppressive therapy including steroids, cytostatic agents, radiotherapy, recent stem cell transplantation, or who have congenital or acquired immunodeficiency disorders and are not receiving replacement therapy with immunoglobulin.

Notes on use of Human Varicella-Zoster Immunoglobulin

Whenever possible, contacts without a definite history of chickenpox should be screened for antibody by a

Human Albumin Biotest 20%, solution for infusion

Human albumin

Read this entire leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Human Albumin Biotest 20% is and what it is used for
2. Before you are given Human Albumin Biotest 20%
3. How you are given Human Albumin Biotest 20%
4. Possible side effects
5. How to store Human Albumin Biotest 20%
6. Further information

What Human Albumin Biotest 20% Is And What It Is Used For

Human Albumin Biotest 20% is a solution for infusion (into a vein). 1000 ml solution contains 200 g human plasma protein of which at least 95% is human albumin.

Human Albumin Biotest 20% is used to restore and maintain circulating blood volume where there is a low blood volume and the use of a colloid, such as albumin, is required.

Before You Are Given Human Albumin Biotest 20%

You will not receive Human Albumin Biotest 20% if:

  • you are allergic (hypersensitive) to albumin preparations or to any of the other ingredients (these are listed in section 6 of this leaflet).

Heparin sodium 10 IU/ml I.V. flush solution

heparin sodium

Please read all of this leaflet carefully before you start having this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  • In this leaflet Heparin sodium 10 IU/ml I.V. flush solution will be called Heparin flush.

In this leaflet:

  • 1. What Heparin flush is and what it is used for
  • 2. Before you have Heparin flush
  • 3. How to use Heparin flush
  • 4. Possible side effects
  • 5. How to store Heparin flush
  • 6. Further information

What Heparin Flush Is And What It Is Used For

Heparin flush belongs to a group of medicines called anticoagulants. It helps to stop the blood from clotting.

Heparin flush is given into an intravenous (I.V.) line. This means it is injected into the tube connected to a vein to keep it clear by preventing the blood from clotting in it. It is not recommended for treatment of harmful blood clots in your body.

Before You Have Heparin Flush

Do not have Heparin flush

  • If you are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

1. Name Of The Medicinal Product

Hepsal 10 I.U./ml flushing solution for maintenance of patency of intravenous devices or Heparin Sodium 10 I.U./ml flushing solution for maintenance of patency of intravenous devices.

2. Qualitative And Quantitative Composition

Heparin sodium 10 I.U./ml (50 I.U. in 5ml)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Flushing solution for maintenance of patency of intravenous devices

A colourless or straw coloured liquid, free from turbidity, and from matter that deposits on standing.

4. Clinical Particulars

4.1 Therapeutic Indications

Heparin is an anticoagulant and acts by potentiating the naturally occurring inhibitors of thrombin and factor X (Xa).

Heparin Sodium 10 I.U./ml Flushing Solution is indicated in any clinical circumstances in which it is desired to maintain the patency of indwelling catheters/cannulae, attendant lines or heparin locks.

4.2 Posology And Method Of Administration

Heparin Sodium 10 I.U./ml Flushing Solution is not recommended for systemic use.

For cleaning indwelling cannulae.

Material to be used as a cannula flush (5ml; 50 units) every four hours or as required.

4.3 Contraindications

The very rare occurrence of established hypersensitivity to heparin is the only contraindication to Heparin Sodium 10 I.U./ml Flushing Solution.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients with known hypersensitivity to low molecular weight heparins.

Rigorous aseptic technique should be observed at all times in its use.

Platelet counts should be measured in

Heparin sodium 1,000 IU/ml ampoule, solution for infusion

heparin sodium

Please read all of this leaflet carefully before you start having this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  • In this leaflet Heparin sodium 1,000 IU/ml ampoule, solution for infusion will be called Heparin infusion.

In this leaflet:

  • 1. What Heparin infusion is and what it is used for
  • 2. Before you have Heparin infusion
  • 3. How to use Heparin infusion
  • 4. Possible side effects
  • 5. How to store Heparin infusion
  • 6. Further information

What Heparin Infusion Is And What It Is Used For

Heparin infusion belongs to a group of medicines called anticoagulants.

Heparin changes the way your blood clots. This means your blood keeps flowing smoothly inside your blood vessels. These are the tubes that carry blood around your body and are called arteries and veins.

Heparin infusion is used :

  • to help stop harmful blood clots in your veins growing bigger (treatment).

An example is a harmful blood clot in a vein deep inside your body. Th

1. Name Of The Medicinal Product

HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. Qualitative And Quantitative Composition

One dose (0.5 ml) contains:

Hepatitis B virus surface antigen, recombinant (HBsAg) *.................. 5 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process. See section 4.3, 4.4 and 4.8.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Suspension for injection in pre-filled syringe

Slightly opaque white suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.

The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.

It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

4.2 Posology And Method Of Administration

Posology

Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection.

Humira

40 mg solution for injection in pre-filled pen

Adalimumab

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • Your doctor must also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira. Keep this Patient Alert Card with you.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Humira is and what it is used for
2. Before you use Humira
3. How to use Humira
4. Possible side effects
5 How to store Humira
6. Further information

What Humira Is And What It Is Used For

Humira is intended for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and psoriasis. It is a medicine that decreases the inflammation process of these diseases. The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Adalimumab binds to a specific protein (tumour necrosis factor or TNF?), which is present at increased levels in inflammatory diseases s

1. Name Of The Medicinal Product

Hexopal Tablets 500mg / Inositol Nicotinate Tablets BP 500mg.

2. Qualitative And Quantitative Composition

Inositol Nicotinate BP 500mg.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Hexopal is indicated for the symptomatic relief of severe intermittent claudication and Raynaud's phenomenon.

4.2 Posology And Method Of Administration

For oral administration.

Adults (including the elderly): The usual dose is 3g daily (i.e. 2 tablets three times a day). The dose may be increased to 4g daily if necessary.

Children: Not recommended.

4.3 Contraindications

Use in patients who have suffered a recent myocardial infarction or are in the acute phase of a cerebrovascular accident.

Use in patients hypersensitive to the active ingredient.

4.4 Special Warnings And Precautions For Use

This product should be used with caution in the presence of cerebrovascular insufficiency or unstable angina.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

There is no evidence of the safety of Hexopal in human pregnancy nor is there adequate evidence from animal work that it is free from hazard. The use of Hexopal in pregnancy should therefore be avoided unless there is no safer alternative.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Side effects are uncommon

1. Name Of The Medicinal Product

Human Albumin Biotest 20%, solution for infusion

2. Qualitative And Quantitative Composition

Human albumin

Human Albumin Biotest 20% is a solution containing 200 g/l of total protein of which at least 95% is human albumin.

The product has a hyperoncotic effect.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion.

A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

4. Clinical Particulars

4.1 Therapeutic Indications

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.

4.2 Posology And Method Of Administration

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient's individual requirements.

Posology

The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid or protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.

If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:

? arterial blood pressure and pulse rate

? central venous pressure

? pulmonary artery wedge pressure

? urine output

? electrolyte

? haemaotcrit / haemoglobin

Lilly

User Manual

Instructions for Use

Read and follow all of these instructions carefully. If you do not follow these instructions completely, you may get too much or too little insulin.

Every time you inject:

  • Use a new needle
  • Prime to make sure the pen is ready to dose
  • Make sure you got a full dose

Also, read the Patient Information Leaflet printed on the back of this manual.

Pen Features

  • A multiple dose, disposable prefilled pen containing 300 units of U-100 insulin
  • Delivers up to 60 units per dose in single unit increments
  • Easy to use; compact size

Pen Parts

Important Notes

  • Read and follow all of these instructions carefully. If you do not follow these instructions completely, you may get too much or too little insulin.
  • Use a new needle for each injection.
  • Be sure a needle is completely attached to the pen before priming, setting (dialling) the dose and injecting your insulin.
  • Prime every time.
  • The pen must be primed before each injection to make sure the pen is ready to dose. Performing the priming step is important to confirm that insulin comes out when you push the injection button, and to remove air that may collect in the insulin cartridge during normal use. See Section “III. Priming the Pen”.
  • If you do not prime, you may get too much or too little insulin.
  • Make sure you get a full dose.
  • To make sure you get

Helixate NexGen 1000 IU powder and solvent for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

Read all of this leaflet carefully before you start using this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or your pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

  • 1. What Helixate NexGen 1000 IU is and what it is used for
  • 2. Before you use Helixate NexGen 1000 IU
  • 3. How to use Helixate NexGen 1000 IU
  • 4. Possible side effects
  • 5. How to store Helixate NexGen 1000 IU
  • 6. Further information

WHAT Helixate NexGen 1000 IU IS AND WHAT IT IS USED FOR

Helixate NexGen 1000 IU belongs to a pharmacotherapeutic group called blood coagulation Factor VIII (ATC-Code B02B D02).

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

One vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units). After reconstitution with the appropriate volume of solvent (water for injections),

1. Name Of The Medicinal Product

HEPARIN (MUCOUS) INJECTION BP

2. Qualitative And Quantitative Composition

Heparin (Mucous) Injection BP 1000 Units/ml: each ml contains Heparin Sodium 1,000 IU

Heparin (Mucous) Injection BP 5000 Units/ml: each ml contains Heparin Sodium 5,000 IU

Heparin (Mucous) Injection BP 25000 Units/ml: each ml contains Heparin Sodium 25,000 IU

3. Pharmaceutical Form

Solution for Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of thrombo-embolic disorders such as deep vein thrombosis, acute arterial embolism or thrombosis, thrombophlebitis, pulmonary embolism and fat embolism.

For prophylaxis against deep vein thrombosis and thrombo-embolic events in susceptible patients.

4.2 Posology And Method Of Administration

For intravenous or subcutaneous injection.

Treatment Dosage:

Intravenous administration

5,000 - 10,000 IU every 4 hours or 500 IU/kg bodyweight daily as a continuous infusion in sodium chloride injection or dextrose injection. Doses should be individually adjusted according to coagulation tests.

Subcutaneous administration

The initial dose is 250 IU/kg bodyweight. Further doses should be given every 12 hours and individually adjusted according to coagulation tests.

Dosage adjustment

It is recommended that dosages be adjusted to maintain a thrombin clotting time, whole blood clotting time or activated partial thromboplastin time 1.5 to 2 times that of control on blood withdrawn 4 - 6 hours after the first injection or

Heparin (mucous) Injection BP

1,000, 5,000 and 25,000 Units/ml

heparin sodium

Please read all of this leaflet carefully before you start having this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
  • In this leaflet Heparin (mucous) Injection will be called heparin.

In this leaflet:

  • 1. What heparin is and what it is used for
  • 2. Before you have heparin
  • 3. How to use heparin
  • 4. Possible side effects
  • 5. How to store heparin
  • 6. Further information

What Heparin Is And What It Is Used For

Heparin belongs to a group of medicines called anticoagulants.

Heparin changes the way your blood clots. This means your blood keeps flowing smoothly inside your blood vessels. These are the tubes that carry blood around your body and are called arteries and veins.

Heparin is used:

  • to help stop harmful blood clots in your veins growing bigger (treatment).
  • to help stop harmful blood clots forming in your veins (prevention).

An example is a harmful blood clot in a vein deep inside your body. This is usually in your leg (deep vein thrombosis or DVT for short). Another example is a clot which blocks the blood supply

1. Name Of The Medicinal Product

Hirudoid Cream

2. Qualitative And Quantitative Composition

Heparinoid 0.3% w/w (Equivalent to 25 000 Units per 100 g cream).

3. Pharmaceutical Form

Topical cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Hirudoid is indicated for the treatment of superficial thrombophlebitis and the soothing relief of superficial bruising and haematoma.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 5 years of age:

Two to six inches (5-15 cm) to be applied up to four times daily to the affected area and gently massaged into the skin.

4.3 Contraindications

Not to be used on large areas of skin, broken skin, sensitive areas of skin or mucous membranes. Not to be used in individuals with a known sensitivity to any active or inactive component of the formulation. Not to be used in children under 5 years of age.

4.4 Special Warnings And Precautions For Use

For external use only. If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no evidence to suggest that Hirudoid should not be used during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

In the absence of any reports of the accidental ingestion of Hirudoid, no specific advice is available. General supportive measures may be appropriate.

1. Name Of The Medicinal Product

Human Tetanus Immunoglobulin, 100 IU/ml sterile solution

2. Qualitative And Quantitative Composition

Human Tetanus Immunoglobulin Ph.Eur. contains human protein, 40-180 g/L of which at least 95% is IgG. The concentration of specific IgG to tetanus toxin is not less than 100 IU/ml in nominal 250 IU vials. The correct volume to give the stated potency is overprinted on the label.

This product is prepared from plasma from screened donors. Donors are selected from the USA.

For excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

1. Post-exposure prophylaxis:

Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty, and in patients with severe deficiency in antibody production or vaccinated patients with high risk wounds.

2. Therapy of clinically manifest tetanus.

Active tetanus vaccination should always be administered in conjunction with tetanus immunoglobulin unless there are contraindications or confirmation of adequate vaccination.

4.2 Posology And Method Of Administration

4.2.1 Posology

Prophylaxis of tetanus prone wounds:

• 250 IU, unless the risk is thought to be extremely high

 

• The dose may be increased to 500 IU in: