bhpardo/ema_en · Datasets at Hugging Face

english stringlengths 2 1.37k
Sími: + 354 530 3700
0.0
Dosing should be titrated as necessary to maintain the haemoglobin target.
- severe loss of appetite leading to weight loss (anorexia),
Minervum 7061 NL-4817 ZK Breda The Netherlands
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with Factor IX inhibitors and a history of allergic reaction.
Day
Epistaxis Nasal ulceration
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
4.
PHARMACEUTICAL PARTICULARS
4.1 Therapeutic indications
Patients with these rare disorders lack certain liver enzymes and are therefore unable to eliminate nitrogen waste, which builds up in the body after eating protein.
76
Paediatric population
The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.
To convert the albumin-corrected serum calcium in mmol/ l value to mg/ dl, multiply by 4.
Abseamed has no influence on the ability to drive and use machines.
Τηλ: +30 210 61 66 100
Do not store above 25°C.
SPECIAL STORAGE CONDITIONS
• 0.1mg/kg body weight as an injection, followed by an infusion (drip) of 0.25mg/kg body weight per hour.
uth ra ge lon no ct du ro lp ina dic Me
AMMONAPS should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema.
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be
METHOD AND ROUTE(S) OF ADMINISTRATION
STATEMENT OF ACTIVE SUBSTANCE(S)
It is supplied as a powder which will be mixed with sterile water before it is given.
It has a dark blue injection button with a raised ring on the top.
101 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
8 June 2001 Date of last renewal:
Do not shake.
4 Clean and stretch the injection site If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen.
The overall incidence of adverse events in children 2 through 11 years of age was similar for the Aerius syrup and the placebo groups.
If your doctor notices that you are suffering from, or are likely to suffer from, any of these severe side- effects described above, you will be immediately transferred to an intensive care unit (ICU) within the hospital, where your doctor can more closely monitor you and prescribe suitable treatment to deal with any dangerous side-effects which have developed.
soreness)
0.99
Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.
Changing the site with each injection may help to prevent such skin changes.
Tinnitus1 Ear pain
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Like all medicines, Aerius can cause side effects although not everybody gets them.
Adult cancer patients with symptomatic anaemia receiving chemotherapy
The pre-filled syringe should not be shaken.
- If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an
If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.
6.
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
1.
OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)
EXP {MM/ YYYY}
C.
Rare:
5.2 Pharmacokinetic properties
In most healthy individuals, the natural ability to fight disease destroys the spores and removes them from the body.
82 The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Hepatic impairment: maraviroc is primarily metabolized and eliminated by the liver.
Three year data in 4411
allergic reaction (e. g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
Medicines should not be disposed of via wastewater or household waste.
Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/ 9 and 3A4.
47 6.4 Special precautions for storage
Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture F).
Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.
Similar pharmacokinetic parameters were observed in a multiple-dose pharmacokinetic study conducted with the syrup formulation in paediatric poor metaboliser subjects 2- to 11-year old diagnosed with allergic rhinitis.
Non response to epoetin alfa therapy may have the following causes: iron, folate, or vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
14.
6 OTHER
Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.
6.1 List of excipients
6.
The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
Monthly tablet Monthly tablet
Malta sanofi-aventis Malta Ltd.
Baraclude reduces the amount of virus in your body, and improves the condition of the liver.
Read the package leaflet before use.
Tlf: + 47 22 88 18 00
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of epoetin alfa in cancer patients.
2.
Some patients may also experience rash.
LOT
In cancer patients
Skin and subcutaneous tissue disorders
4.6 Pregnancy and lactation
Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
When reconstituted 250 microgram/ ml (8 mio IU/ ml) Interferon beta-1b.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
If the haemoglobin is rising by more than 2 g/ dl (1.25 mmol/ l) per month, or if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.
Solvent for BeneFIX
Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.
Hepatobiliary disorders liver function disorders hepatitis
CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.
SPECIAL STORAGE CONDITIONS
MARKETING AUTHORISATION NUMBER(S)
If you don’ t treat it, this could lead to diabetic coma and death.

Sími: + 354 530 3700

0.0

Dosing should be titrated as necessary to maintain the haemoglobin target.

- severe loss of appetite leading to weight loss (anorexia),

Minervum 7061 NL-4817 ZK Breda The Netherlands

Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with Factor IX inhibitors and a history of allergic reaction.

Day

Epistaxis Nasal ulceration

When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.

4.

PHARMACEUTICAL PARTICULARS

4.1 Therapeutic indications

Patients with these rare disorders lack certain liver enzymes and are therefore unable to eliminate nitrogen waste, which builds up in the body after eating protein.

76

Paediatric population

The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.

To convert the albumin-corrected serum calcium in mmol/ l value to mg/ dl, multiply by 4.

Abseamed has no influence on the ability to drive and use machines.

Τηλ: +30 210 61 66 100

Do not store above 25°C.

SPECIAL STORAGE CONDITIONS

• 0.1mg/kg body weight as an injection, followed by an infusion (drip) of 0.25mg/kg body weight per hour.

uth ra ge lon no ct du ro lp ina dic Me

AMMONAPS should therefore be used with caution in patients with congestive heart failure or severe renal insufficiency, and in clinical conditions where there is sodium retention with oedema.

A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be

METHOD AND ROUTE(S) OF ADMINISTRATION

STATEMENT OF ACTIVE SUBSTANCE(S)

It is supplied as a powder which will be mixed with sterile water before it is given.

It has a dark blue injection button with a raised ring on the top.

101 Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51

8 June 2001 Date of last renewal:

Do not shake.

4 Clean and stretch the injection site If you need to, use an alcohol wipe to clean the skin at the injection site you’ve chosen.

The overall incidence of adverse events in children 2 through 11 years of age was similar for the Aerius syrup and the placebo groups.

If your doctor notices that you are suffering from, or are likely to suffer from, any of these severe side- effects described above, you will be immediately transferred to an intensive care unit (ICU) within the hospital, where your doctor can more closely monitor you and prescribe suitable treatment to deal with any dangerous side-effects which have developed.

soreness)

0.99

Sodium acetate, trihydrate; acetic acid glacial, arginine hydrochloride, polysorbate 20 and water for injections.

Changing the site with each injection may help to prevent such skin changes.

Tinnitus1 Ear pain

If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.

Like all medicines, Aerius can cause side effects although not everybody gets them.

Adult cancer patients with symptomatic anaemia receiving chemotherapy

The pre-filled syringe should not be shaken.

- If you suffer from a liver or cardiac disease or if you have recently had surgery, there is an

If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious.

6.

An increased relative risk of thromboembolic events (RR 1.67, 95% CI:

1.

OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)

EXP {MM/ YYYY}

C.

Rare:

5.2 Pharmacokinetic properties

In most healthy individuals, the natural ability to fight disease destroys the spores and removes them from the body.

82 The use of medicinal products called amantadine (for the treatment of Parkinson´s disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Hepatic impairment: maraviroc is primarily metabolized and eliminated by the liver.

Three year data in 4411

allergic reaction (e. g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)

Medicines should not be disposed of via wastewater or household waste.

Studies in man suggest no induction of the main inducible cytochrome P450, 1A, 2C8/ 9 and 3A4.

47 6.4 Special precautions for storage

Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture F).

Misuse of Aranesp by healthy persons may lead to an excessive increase in packed cell volume.

Similar pharmacokinetic parameters were observed in a multiple-dose pharmacokinetic study conducted with the syrup formulation in paediatric poor metaboliser subjects 2- to 11-year old diagnosed with allergic rhinitis.

Non response to epoetin alfa therapy may have the following causes: iron, folate, or vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.

14.

6 OTHER

Treatment with pioglitazone has been shown to reduce hepatic glucose output and to increase peripheral glucose disposal in the case of insulin resistance.

6.1 List of excipients

6.

The most frequent of adverse events reported in excess of placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.

Monthly tablet Monthly tablet

Malta sanofi-aventis Malta Ltd.

Baraclude reduces the amount of virus in your body, and improves the condition of the liver.

Read the package leaflet before use.

Tlf: + 47 22 88 18 00

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of epoetin alfa in cancer patients.

2.

Some patients may also experience rash.

LOT

In cancer patients

Skin and subcutaneous tissue disorders

4.6 Pregnancy and lactation

Beta-blocking agents may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia.

There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.

When reconstituted 250 microgram/ ml (8 mio IU/ ml) Interferon beta-1b.

Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.

If the haemoglobin is rising by more than 2 g/ dl (1.25 mmol/ l) per month, or if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.

Solvent for BeneFIX

Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.

The pharmacokinetic of digoxin was not altered by coadministration of irbesartan.

Hepatobiliary disorders liver function disorders hepatitis

CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.

SPECIAL STORAGE CONDITIONS

MARKETING AUTHORISATION NUMBER(S)

If you don’ t treat it, this could lead to diabetic coma and death.